Cancer Treatment at Mayo Clinic

Clinical Trials

Below is a list of Cancer Treatment at Mayo Clinic clinical trials from the clinical trials database at Mayo Clinic.

Mayo's clinical trials include experimental treatments, often unavailable elsewhere, which frequently lead to improved patient care for people worldwide. Patients should ask their doctor at Mayo about clinical trials appropriate for their situation.

A Molecular Staging Study of Endometrial Cancer (GOG 0210)
This research study is being done to:

• Collect tissue, urine and blood samples from patients who have endometrial cancer.
• Collect information from patients (for example: age, race, level of education, health history, family health history, and treatments for cancer).

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A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)
Principal Investigators: The principal investigators (PIs) will be transplant physicians at all participating U.S. transplant centers. Study Design: This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.
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A Phase 1 Study of BMS-833923 (XL139) in Subjects With Advanced or Metastatic Cancer
The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule
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A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
OBJECTIVES: Primary - To compare invasive disease-free survival of patients with early-stage breast cancer treated with metformin vs placebo in addition to standard adjuvant therapy. Secondary - To compare overall survival of these patients.
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A Safety and Efficacy Study of Patients With Metastatic or Locally Advanced (Unresectable) Chondrosarcoma
Study IPI-926-04 is a Phase 2, double-blind, placebo-controlled, multicenter, trial evaluating the safety and efficacy of IPI-926 in patients with metastatic or locally advanced (unresectable) chondrosarcoma. The study includes an optional cross-over to open-label IPI-926 for patients randomly assigned to placebo who experience documented disease progression.
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A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation
The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.
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A Study of MLN9708 Administered in Combination With Lenalidomide and Low-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
This open-label, multicenter clinical trial using the oral formulation of MLN9708 will have both phase 1 and phase 2 components. Both phases will include patients with newly diagnosed multiple myeloma who have not previously received systemic treatment.
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A Study of Oral Sapacitabine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
This is a multicenter, randomized, Phase 3 study comparing three drug regimens (arms) as the front-line treatment of elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia (AML) who are not candidates for intensive induction chemotherapy.
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A Study of Ramucirumab in Patients With Gastric, Esophageal and Gastroesophageal Cancer (IRB #: 10-000583, 14T-MC-JVBT, NCT01246960)
Patients are being asked to take part in this research study because they have been diagnosed with esophageal, gastroesophageal junction, or stomach cancer. This study is being done to see whether ramucirumab can slow tumor growth in people with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or stomach.
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A Study of Two Subcutaneous Regimens of SGI-110, a DNA Hypomethylating Agent, in Subjects With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
SGI-110 is a dinucleotide of decitabine and deoxyguanosine linked with a natural phosphodiester linkage. SGI-110 is resistant to deamination by cytidine deaminases which may result in gradual release of decitabine both extra and intracellularly, leading to more prolonged exposures to decitabine due to potentially higher average concentrations and longer half life.
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A Study to Determine the Efficacy and Safety of Lenalidomide in Patients With Mantle Cell NHL Who Have Relapsed or Progressed After Treatment With Bortezomib or Are Refractory to Bortezomib. The "EMERGE" Trial
To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.
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A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell CLL Following Second Line Therapy (THE CONTINUUM TRIAL)
The purpose of this study is to determine if lenalidomide (Revlimid®) is safe and effective as a maintenance therapy at improving further the quality of the response you achieved with your last therapy and at prolonging the duration of your response.
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ABT-888 and Topotecan Hydrochloride in Treating Patients With Advanced Solid Tumors or Relapsed or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
OBJECTIVES: - To determine the maximum-tolerated dose of ABT-888 and topotecan hydrochloride in patients with advanced solid tumors. (Phase I) - To identify any anti-tumor activity of this treatment combination, as assessed by objective response in patients with advanced solid tumors.
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ABT-888 With Cyclophosphamide in Refractory BRCA-Positive Ovarian, Primary Peritoneal or Ovarian High-Grade Serous Carcinoma, Fallopian Tube Cancer, Triple-Negative Breast Cancer, and Low-Grade Non-Hodgkin's Lymphoma
Background: - The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining genomic stability by regulating a variety of DNA repair mechanisms. - Individuals with deleterious mutations in the BRCA1 or BRCA2 tumor suppressor genes have an increased risk of developing breast and ovarian cancers due to impaired or defective DNA damage repair; these individuals have an increased susceptibility to DNA-damaging agents and PARP
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ACNS0334, A Phase III Study for the Treatment of Newly Diagnosed Supratentorial PNET (primitive neuroectodermal tumor) and High Risk Medulloblastoma in Children < 36 months Old with Intensive Induction Chemotherapy with Methotrexate Followed by Consolidation with Stem Cell Rescue vs. the Same Therapy Without Methotrexate
Study Rationale: Parents/ Guardians are being asked to allow their child to take part in this study because their child is less than three years old and has a tumor called a high risk medulloblastoma or primitive neuroectodermal tumor (PNET).
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Acute Pain Caused by Paclitaxel in Patients With Cancer
OBJECTIVES: - To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.
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AFP464 in Treating Patients With Advanced Solid Tumors
OBJECTIVES: - Determine the maximum tolerated dose (MTD) of AFP464 in patients with advanced solid tumors. - Evaluate the toxicity profile of AFP464. - Characterize the plasma pharmacokinetics and urinary excretion of AFP464 and aminoflavone in these patients.
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Analyses of Human Samples Collected in Clinical Trials
Various human samples (e.g., serum, plasma, whole blood, erythrocytes, urine, feces, bile, and/or saliva) will be collected from cancer patients enrolled on approved clinical trials, in accordance with the local protocol. These trials are being conducted at outside institutions, in collaboration with the National Cancer Institute (NCI) and the samples will be sent to the NCI for pharmacological analysis, involving determination of parent drug
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Analysis of Surgery in Patients Presenting With Stage IV Breast Cancer
The purpose of this study is to study patients presenting with stage IV breast cancer. Stage IV means that the breast cancer has spread to another part of the body outside the breast.
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Androgen Ablation Therapy With or Without Chemotherapy in Treating Patients With Metastatic Prostate Cancer
OBJECTIVES: Primary - Evaluate the ability of early chemotherapy to improve overall survival of patients commencing androgen deprivation for metastatic prostate cancer. Secondary - Determine whether early chemotherapy can increase the time to clinical progression (radiographic or symptomatic deterioration due to disease) over hormonal therapy alone.
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Assessing Ear Damage in Young Cancer Patients Treated With Cisplatin
OBJECTIVES: - Determine the optimal criteria for determination of ototoxicity in younger cancer patients treated with cisplatin. - Determine the feasibility of including ultrahigh frequency and evoked otoacoustic emission testing as adjunctive measures of ototoxicity.
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Aurora A Kinase Inhibitor MLN8237 and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTD) with the combination of MLN8237 and bortezomib. (Phase I) II. To describe the toxicities associated with the combination of MLN8237 and bortezomib.
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Azacitidine and Entinostat in Treating Patients With Advanced Breast Cancer
OBJECTIVES: Primary - To evaluate objective response rate by RECIST criteria of the combination of azacitidine (5-AZA) and entinostat in women with advanced triple-negative or hormone-refractory breast cancer. Secondary - To determine the safety and tolerability of the combination of 5-AZA and entinostat in women with advanced breast cancer.
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Azacitidine and Entinostat in Treating Patients With Metastatic Colorectal Cancer
OBJECTIVES: Primary objectives - To determine the preliminary efficacy of the combination of azacitidine and entinostat in patients with metastatic colorectal cancer. Secondary objectives - To explore the effects of this regimen on the time to progression in these patients.
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Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia
OBJECTIVES: Primary - Compare the overall response rate (complete, partial, and hematologic improvement-major by International Working Group [IWG] criteria) in patients with treatment-induced or non-treatment-induced myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (dysplastic), or acute myeloid leukemia with multilineage dysplasia treated with azacitidine with vs without entinostat.
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AZD0530 in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
OBJECTIVES: Primary - To determine the 6-month survival of biomarker-positive patients with previously treated metastatic pancreatic cancer receiving AZD0530. - To determine the adverse events of this drug in these patients. Secondary - To evaluate the response rate in patients treated with this drug.
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AZD2171 in Treating Patients With Relapsed, Refractory, or Untreated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome
OBJECTIVES: Primary - Evaluate the objective response rate in patients with relapsed, refractory, or untreated acute myeloid leukemia or high-risk myelodysplastic syndromes treated with AZD2171. Secondary - Determine the toxicity of this drug in these patients.
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Bendamustine Hydrochloride and Rituximab With or Without Bortezomib Followed by Rituximab With or Without Lenalidomide in Treating Patients With High-Risk Stage II, Stage III, or Stage IV Follicular Lymphoma
OBJECTIVES: Primary - To compare the complete remission rate in patients with high-risk follicular lymphoma receiving induction therapy comprising bendamustine hydrochloride and rituximab with vs without bortezomib. - To compare the 1-year post-induction disease-free survival rate in patients receiving continuation therapy comprising rituximab with vs without lenalidomide.
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Bendamustine Hydrochloride, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed Multiple Myeloma
PRIMARY OBJECTIVES: I. To determine the MTD of bendamustine and lenalidomide in combination with dexamethasone in subjects with MM in first or second relapse. (Phase I) II. To evaluate the confirmed response rate of bendamustine in combination with lenalidomide and dexamethasone in subjects with MM in first or second relapse.
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Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
OBJECTIVES: Primary - To compare the progression-free survival (PFS) rate in patients with stage II, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with bevacizumab in combination with IV vs intraperitoneal (IP) chemotherapy as first-line therapy.
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Bevacizumab and Sorafenib as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Liver Cancer
OBJECTIVES: Primary - Determine the maximum tolerated dose of bevacizumab in combination with sorafenib tosylate in patients with locally advanced or metastatic hepatocellular carcinoma. (Phase I closed to accrual as of 11/03/2010) - Determine time to progression in these patients.
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Bicalutamide and Raloxifene in Treating Patients With Metastatic or Hormone-Refractory Prostate Cancer
OBJECTIVES: I. To describe the 6-month progression-free survival rate, progression-free survival, and overall survival of patients receiving bicalutamide and raloxifene. II. To describe the adverse event profile of combined treatment with bicalutamide and raloxifene (adverse events graded using the NCI CTCAE version 3.0).
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Bicalutamide in Treating Patients With Metastatic Breast Cancer
OBJECTIVES: Primary - Determine the 6-month efficacy rate of bicalutamide as first-, second-, or third-line therapy in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer. Secondary - Determine the 6-month progression-free survival of patients treated with this drug.
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Bicalutamide With or Without MK2206 in Treating Patients With Previously Treated Prostate Cancer
OBJECTIVES: Primary - To compare the two regimens on the proportion of patients with undetectable PSA level (< 0.2 ng/mL) at 44 weeks. Secondary - To compare the proportion of patients with PSA decline ≥ 85% at 44 weeks treated with these regimens.
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Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma
OBJECTIVES: - Evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. - Assess the prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q; the expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75^NTR) receptors; and telomerase activity in these patients.
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Biospecimen Resource for Familial Pancreas Research, a Data and Tissue Registry (also known as a bio-repository, bio-bank, data and tissue database, data and tissue bank, etc.) to Help Advance Research in Familial Pancreas Disease.
The research staff is collecting clinical and family histories, blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, including pancreatic cancer and melanoma. This will help the researchers to learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
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Biospecimen Resource for Pancreas Research, a Data & Tissue Bank (also known as a bio-repository, bio-bank, data & tissue database, data & tissue registry, etc.) to Help Advance Research in Pancreas Disease.
This study is being done to develop better ways to screen people at risk for pancreatic conditions, including pancreatic cancer. It is being done to try to find new genes or substances that may make some people more likely to develop pancreatic conditions, and to find agents that may help to prevent, treat, or cure them.
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BNC105P in Combination With Everolimus/Following Everolimus For Progressive Metastatic Clear Cell Renal Cell Carcinoma
OUTLINE: This is a multi-center study. Phase I: Patients will be accrued in the classic 3 patients per dose per cohort design, 21-day cycle - Dose Level 1 Everolimus 10 mg BNC105P 4.2
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Bortezomib and Combination Chemotherapy in Treating Young Patients With Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
OBJECTIVES: Primary - To estimate the toxicity of bortezomib in combination with intensive reinduction chemotherapy in young patients with relapsed acute lymphoblastic leukemia or lymphoblastic lymphoma. - To estimate the second complete remission rate at the end of block 1 reinduction chemotherapy and the 4-month event-free survival of these patients.
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Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia
OBJECTIVES: Primary - To determine the toxicities and tolerability of bortezomib in combination with standard-relapse acute myeloid leukemia (AML) therapy (idarubicin/cytarabine or etoposide/high-dose cytarabine) in pediatric and young adult patients with relapsed or primary-refractory or secondary AML.
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Bortezomib, Liposomal Doxorubicin Hydrochloride, Dexamethasone, and Cyclophosphamide in Treating Patients With Multiple Myeloma That Relapsed After Autologous Stem Cell Transplant
OBJECTIVES: Primary - To evaluate the 1-year survival of patients with relapsed multiple myeloma treated with bortezomib, pegylated liposomal doxorubicin hydrochloride, dexamethasone, and cyclophosphamide. Secondary - To evaluate response rates in patients treated with this regimen.
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Bortezomib, Rituximab, and Dexamethasone With or Without Temsirolimus in Treating Patients With Untreated or Relapsed Waldenstrom Macroglobulinemia or Relapsed or Refractory Mantle Cell or Follicular Lymphoma
OBJECTIVES: Primary - To determine the maximum-tolerated dose (MTD) of temsirolimus in combination with bortezomib, rituximab, and dexamethasone in patients with untreated or relapsed Waldenstrom macroglobulinemia or relapsed/refractory mantle cell or follicular lymphoma.
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Brain Function in Young Patients Receiving Methotrexate for Acute Lymphoblastic Leukemia
OBJECTIVES: - Determine the neuropsychological function in children with acute lymphoblastic leukemia treated with either high-dose methotrexate or escalating-dose methotrexate in the absence of cranial radiation and nelarabine. - Identify host polymorphisms that predict an increased risk of neurocognitive dysfunction or acute neurotoxicity in these patients.
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Calcium Gluconate and Magnesium Sulfate in Preventing Neurotoxicity in Patients With Colon Cancer or Rectal Cancer Receiving Oxaliplatin-Based Combination Chemotherapy
OBJECTIVES: Primary - To determine whether 2 schedules of calcium gluconate and magnesium sulfate infusions (given before and after chemotherapy or just before chemotherapy) can prevent or ameliorate chronic, cumulative oxaliplatin-induced sensory neurotoxicity in patients with colon or rectal cancer receiving adjuvant FOLFOX chemotherapy comprising leucovorin calcium, fluorouracil, and oxaliplatin.
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Capecitabine and Lapatinib With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
OBJECTIVES: Primary - To compare the progression-free survival of patients with HER2-positive stage IIIB, IIIC, or IV breast cancer treated with lapatinib ditosylate and capecitabine with vs without cixutumumab. Secondary - To assess the safety and tolerability of these regimens in these patients.
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Capecitabine, Gemcitabine, and Radiation Therapy in Treating Patients With Cholangiocarcinoma of the Gallbladder or Bile Duct
OBJECTIVES: - To estimate the stratum-specific (R0 and R1) and overall 2-year survival probabilities of patients with extrahepatic cholangiocarcinoma treated with adjuvant chemotherapy comprising capecitabine and gemcitabine hydrochloride, followed by capecitabine and radiotherapy.
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Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer
OBJECTIVES: Primary - To compare overall survival (OS) in patients with stage IV or recurrent non-small cell lung cancer treated with carboplatin, paclitaxel, and bevacizumab (if appropriate) with vs without cetuximab. - To compare progression-free survival (PFS) of EGFR FISH-positive patients by institutional review.
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Carboplatin and Paclitaxel With or Without Cisplatin and Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IVA Endometrial Cancer
OBJECTIVES: Primary - Compare the recurrence-free survival of patients with stage I-IVA endometrial carcinoma treated with adjuvant chemoradiotherapy comprising cisplatin and tumor volume-directed radiotherapy followed by carboplatin and paclitaxel vs carboplatin and paclitaxel alone.
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Carboplatin, Paclitaxel, and Bevacizumab With or Without Everolimus in Treating Patients With Metastatic Malignant Melanoma
OBJECTIVES: Primary - To assess whether there is sufficient promise of an impact of the addition of everolimus to the combination of carboplatin, paclitaxel, and bevacizumab on progression-free survival that it would be recommended for further testing in patients with metastatic malignant melanoma.
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Carboplatin, Paclitaxel, and Everolimus in Treating Patients With Previously Untreated Cancer of Unknown Primary
OBJECTIVES: Primary - Evaluate the response rate in patients with previously untreated cancer of unknown primary treated with the combination of carboplatin, paclitaxel, and everolimus. Secondary - Assess time to progression, overall survival, duration of response, and time to treatment failure in patients treated with this regimen.
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Caspofungin Acetate or Fluconazole in Preventing Invasive Fungal Infections in Patients With Acute Myeloid Leukemia Who Are Undergoing Chemotherapy
OBJECTIVES: Primary - To determine if prophylaxis with caspofungin administered during periods of neutropenia following chemotherapy for acute myeloid leukemia (AML) is associated with a lower incidence of proven or probable invasive fungal infections (IFI) compared with fluconazole.
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CC-4047 and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Amyloidosis
OBJECTIVES: - To assess the response rate and duration of remission with low-dose CC-4047 plus dexamethasone in patients with relapsed or refractory multiple myeloma or amyloidosis. - To assess the toxicity of CC-4047 plus dexamethasone in this patient population.
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Cediranib Maleate and Selumetinib in Treating Patients With Solid Malignancies
OBJECTIVES: - To determine the maximum-tolerated dose (MTD) of cediranib maleate (AZD2171) in combination with selumetinib (AZD6244 hydrogen sulfate). - To describe the toxicity profile associated with AZD2171 in combination with AZD6244 hydrogen sulfate.
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Chemoembolization With or Without Sorafenib Tosylate in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery
OBJECTIVES: Primary - To compare the progression-free survival of patients with unresectable hepatocellular carcinoma treated with chemoembolization with versus without sorafenib tosylate. Secondary - To compare the overall survival of patients treated with these regimens.
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Chemotherapy and Pelvic Radiation Therapy With or Without Additional Chemotherapy in Treating Patients With High-Risk Early-Stage Cervical Cancer After Radical Hysterectomy
OBJECTIVES: Primary - To determine if administering adjuvant systemic chemotherapy after chemoradiotherapy will improve disease-free survival compared to chemoradiotherapy alone in patients with high-risk early-stage cervical carcinoma found to have positive nodes and/or positive parametria after radical hysterectomy.
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Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor
OBJECTIVES: Primary - Determine whether carboplatin radiosensitization increases long-term, event-free survival of pediatric patients with newly diagnosed, previously untreated, high-risk medulloblastoma or supratentorial primitive neuroectodermal tumors. - Determine whether isotretinoin increases long-term, event-free survival of these patients.
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Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-Small Lung Cancer That Was Removed By Surgery
OBJECTIVES: Primary - Compare overall survival of patients with completely resected stage IB (tumors ≥ 4cm)-IIIA non-small cell lung cancer treated with adjuvant chemotherapy with or without bevacizumab. Secondary - Compare disease-free survival of patients treated with these regimens.
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Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors
OBJECTIVES: - To determine the maximally tolerated dose (MTD) of cilengitide and paclitaxel at weekly dose schedule. - To describe the toxicities associated with cilengitide and paclitaxel. - To describe any antitumor activity of cilengitide and paclitaxel at weekly dose schedule.
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Cisplatin and Etoposide Phosphate With or Without GDC-0449 or Cixutumumab in Treating Patients With Extensive-Stage Small Cell Lung Cancer
OBJECTIVES: Primary - To evaluate the progression-free survival of patients with extensive stage small cell lung cancer treated with cisplatin and etoposide with or without Hedgehog antagonist GDC-0449 or cixutumumab. Secondary - To evaluate the response rate in patients treated with these regimens.
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Cixutumumab and Temsirolimus in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
OBJECTIVES: Primary - To establish the recommended dose level of cixutumumab and temsirolimus for the phase II study in patients with metastatic breast cancer. (Phase I) - To examine the safety profile of this combination in patients with metastatic breast cancer.
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Cixutumumab in Treating Patients With Relapsed or Refractory Solid Tumors
OBJECTIVES: Primary - To determine the response rate in patients with relapsed or refractory malignant solid tumors treated with cixutumumab. - To further define and describe the toxicities of this drug in these patients.
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Clinical Study of PM01183 in Patients With Acute Leukemia
Open-Label, Dose-Escalating, Clinical and Pharmacokinetic Phase I Study of PM01183 in Patients with Advanced Acute Leukemia to determine the maximum tolerated dose (MTD) and the recommended dose (RD) of PM01183 administered as 1-hour intravenous (i.v.)
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Clofarabine and Cytarabine in Treating Young Patients With Refractory or Relapsed Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
OBJECTIVES: Primary - To define the overall response rate (complete remission or remission without platelet recovery) in young patients with relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) treated with clofarabine in combination with cytarabine.
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Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
OBJECTIVES: Primary - To compare the overall survival of older patients with newly diagnosed acute myeloid leukemia (AML) treated with clofarabine as induction therapy and consolidation therapy vs standard daunorubicin hydrochloride and cytarabine.
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Collecting and Storing Biological Samples From Patients With Ewing Sarcoma
OBJECTIVES: - Collect biological specimens, including associated demographic and clinical data, from patients with Ewing sarcoma. - Provide a repository for long-term storage of Ewing sarcoma-related biological materials. - Make collected specimens available to qualified researchers to understand the biology of Ewing sarcoma and correlate these results with demographic and clinical data.
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Collecting and Storing Biological Samples From Young Patients With Hodgkin's Lymphoma
OBJECTIVES: - Establish a biologic specimen repository (of tumor tissue, tissue arrays, lymphoblastoid cell lines, host DNA, tumor and host RNA, serum, and plasma) and database linked to clinical features and outcomes from well-characterized cohorts of children and young adults with Hodgkin's lymphoma.
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Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors
OBJECTIVES: - Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children's Oncology Group institutions. - Provide a repository for long-term storage of specimens from these patients.
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Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
OBJECTIVES: - Collect malignant, borderline malignant neoplasms, and related biological specimens from Children's Oncology Group institutions for cases in which there is no disease-specific biologic protocol. - Provide a repository for long-term storage of malignant, borderline malignant neoplasms, and related biological specimens from these patients.
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Collecting and Storing Samples of Blood and Tumor Tissue From Patients With Osteosarcoma
OBJECTIVES: - To collect biological specimens from patients with osteosarcoma at Children's Oncology Group (COG) institutions. - To provide a repository for long-term storage of osteosarcoma-related biological materials. - To make these specimens available to qualified researchers to understand the biology of osteosarcoma and correlate these results with the patients' clinical data.
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Collecting and Storing Samples of Bone Marrow and Blood From Patients With Relapsed Acute Lymphoblastic Leukemia or Non-Hodgkin Lymphoma
OBJECTIVES: - Establish a mechanism to bank specimens of tumor cells and host germline DNA from patients with acute lymphoblastic leukemia (ALL) or non-Hodgkin lymphoma at first and subsequent relapse. - Make these specimens available to qualified researchers to study the biology of ALL.
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Collecting and Storing Tissue Samples From Patients With Rare or Cutaneous Non-Hodgkin Lymphoma
OBJECTIVES: - To determine the clinical features, treatment, and outcome of patients with rare or cutaneous pediatric non-Hodgkin lymphoma (NHL). - To determine the pathologic and biologic features of these diseases, including molecular diagnostics and flow cytometry.
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Collecting and Storing Tissue, Blood, and Bone Marrow Samples From Patients With Rhabdomyosarcoma or Other Soft Tissue Sarcoma
OBJECTIVES: - Collect human tumor tissue and other biological specimens (blood, serum, and bone marrow) from patients with rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma diagnosed and/or treated at a Children's Oncology Group (COG) member institution.
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Collecting Blood and Tissue Samples From Family Members of Patients With Pancreatic Diseases, Pancreatic Cancer, and Melanoma
OBJECTIVES: - To collect clinical history, family history, and blood and/or tissue samples from family members of patients diagnosed with pancreatic diseases, pancreatic cancer, or melanoma. - To learn whether inherited factors increase the risk of pancreatic diseases, pancreatic cancer, or other cancers.
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Collecting Medical Information and Tissue Samples From Patients With Pancreatic Cancer or Other Pancreatic Disorders
OBJECTIVES: Primary - To collect clinical data and family histories and blood and/or tissue samples from patients diagnosed with pancreatic diseases, including pancreatic cancer, for use in future studies. - To collect information regarding food preparation and intake in these patients.
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Collecting Tissue Samples From Patients With Leukemia or Other Blood Disorders Planning to Enroll in an ECOG Leukemia Treatment Clinical Trial
OBJECTIVES: - To provide a mechanism for sample collection and submission for diagnostic review to determine eligibility of patients with suspected leukemia or related hematologic disorders for enrollment on ECOG leukemia clinical trials.
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Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
OBJECTIVES: Primary - To compare the pathologic complete response rate (pCR) within the breast of patients with breast cancer receiving neoadjuvant combination chemotherapy comprising fluoroucacil, epirubicin hydrochloride, and cyclophosphamide followed by paclitaxel and trastuzumab vs neoadjuvant paclitaxel with trastuzumab (Herceptin®) followed by combination chemotherapy comprising fluoroucacil, epirubicin hydrochloride, cyclophosphamide, and trastuzumab.
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Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
OBJECTIVES: Primary - Compare the early response rates in patients with intermediate-risk rhabdomyosarcoma (RMS) treated with vincristine, dactinomycin, and cyclophosphamide (VAC) vs VAC alternating with vincristine and irinotecan hydrochloride (VI) in combination with radiotherapy.
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Combination Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin Lymphoma
OBJECTIVES: Primary - To maintain the overall survival (as defined by 4-year "second-event"-free survival) at or above 95% for pediatric patients with high-risk Hodgkin lymphoma (HL). Secondary - To maintain 3-year event-free survival at or above 93% for patients with high-risk HL.
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Combination Chemotherapy Followed By Docetaxel or Ixabepilone in Treating Patients Who Have Undergone Surgery for Nonmetastatic Breast Cancer
OBJECTIVES: Primary - To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.
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Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk Medulloblastoma
OBJECTIVES: Primary - Determine if treatment of pediatric patients with newly diagnosed supratentorial primitive neuroectodermal CNS tumors or high-risk medulloblastoma with intensive induction chemotherapy comprising vincristine, etoposide, cyclophosphamide, and cisplatin in combination with high-dose methotrexate and leucovorin calcium followed by consolidation chemotherapy comprising carboplatin and thiotepa and peripheral blood stem cell rescue results in a higher complete response rate then in patients treated with the
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Combination Chemotherapy in Treating Patients With Non-Metastatic Extracranial Ewing Sarcoma
OBJECTIVES: Primary - Test the effect of the combination of vincristine, cyclophosphamide, and topotecan (VTC) added to the standard 5-drug chemotherapy interval-compressed backbone on event-free survival (EFS) and overall survival of children and young adults with Ewing sarcoma.
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Combination Chemotherapy in Treating Young Patients With Down Syndrome and Acute Myeloid Leukemia or Myelodysplastic Syndromes
OBJECTIVES: Primary - Determine the event-free survival (EFS) and overall survival rates in pediatric patients with Down syndrome and acute myeloid leukemia or myelodysplastic syndromes treated with induction therapy comprising cytarabine, daunorubicin hydrochloride, thioguanine, and asparaginase followed by intensification therapy comprising cytarabine and etoposide.
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
OBJECTIVES: - To describe the outcomes (i.e., complete response rate, event-free survival, disease-free survival [DFS], and overall survival [OS]) of adolescents and young adults with newly diagnosed acute lymphoblastic leukemia (ALL) treated with a pediatric chemotherapy regimen by adult hematologists/oncologists at multiple sites.
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Promyelocytic Leukemia
OBJECTIVES: Primary - To decrease the total anthracycline dose from the best current published results in patients with standard-risk childhood acute promyelocytic leukemia (APL) while still maintaining a comparable event-free survival (EFS). Secondary - To assign treatment based on risk stratification by WBC at diagnosis.
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Liver Cancer
OBJECTIVES: Primary - To estimate the event-free survival (EFS) in pediatric patients with stage I (non-PFH, non-SCU) and stage II (non-SCU) hepatoblastoma treated with surgical resection followed by 2 courses of cisplatin, fluorouracil, and vincristine (C5V).
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Combination Chemotherapy in Treating Young Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
OBJECTIVES: Primary - Compare the relative safety and efficacy of augmented Berlin-Frankfurt-Münster-86 multiagent chemotherapy with or without nelarabine in younger patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-NHL).
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Combination Chemotherapy Plus Bevacizumab With or Without Oxaliplatin in Treating Older Patients With Metastatic Colorectal Cancer
OBJECTIVES: Primary - To compare the progression-free survival (PFS) of elderly patients with metastatic colorectal carcinoma who are randomized to receive fluoropyrimidine-based therapy plus bevacizumab, with or without oxaliplatin. Secondary - In a prospectively planned pooled analysis with a similar trial to be conducted by the Japanese Clinical Oncology Group (JCOG), evaluate and compare the overall survival (OS) of elderly patients with metastatic colorectal carcinoma who
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Combination Chemotherapy With or Without Lestaurtinib in Treating Infants With Newly Diagnosed Acute Lymphoblastic Leukemia
OBJECTIVES: Primary - To compare the 3-year event-free survival of infants with mixed lineage leukemia rearranged (MLL-R) acute lymphoblastic leukemia (ALL) randomized to treatment with a modified P9407 chemotherapy backbone with or without the FLT3 inhibitor lestaurtinib.
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Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma
OBJECTIVES: Primary - Compare the event-free and overall survival of patients with tumor of the Ewing's family treated with standard induction chemotherapy comprising vincristine, dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC) transplantation with or without radiotherapy and/or surgery.
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Combination Chemotherapy With or Without Radiation Therapy in Treating Young Patients With Newly Diagnosed Stage III or Stage IV Wilms Tumor
OBJECTIVES: Primary - Determine the 4-year event-free survival (EFS) of patients with stage IV favorable histology (FH) Wilms tumor with pulmonary metastases only who have complete resolution of pulmonary lesions without whole lung irradiation treated with DD4A chemotherapy comprising vincristine, dactinomycin, and doxorubicin hydrochloride.
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Combination Chemotherapy, Radiation Therapy, and an Autologous Peripheral Blood Stem Cell Transplant in Treating Young Patients With Atypical Teratoid/Rhabdoid Tumor of the Central Nervous System
OBJECTIVES: Primary - To determine the 6-, 12-, and 24-month event-free survival and overall survival of children (birth to 21 years of age) with atypical teratoid/rhabdoid CNS tumors (AT/RT), diagnosed based on histology, immunophenotyping, and modern molecular and immunohistochemical analysis of INI1, treated with surgery, intensive chemotherapy combined with stem cell rescue, and radiation therapy.
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Combination Chemotherapy, Radiation Therapy, and/or Surgery in Treating Patients With High-Risk Kidney Tumors
OBJECTIVES: Primary - Evaluate whether a treatment regimen containing cyclophosphamide, carboplatin, and etoposide alternating with vincristine, doxorubicin hydrochloride, and cyclophosphamide (regimen UH-1) improves the event-free and overall survival of patients with diffuse anaplastic Wilms' tumor (DAWT) as compared to historical controls.
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Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma
OBJECTIVES: Primary - To improve the 3-year event-free survival (EFS) rate of high-risk neuroblastoma patients through treatment with a tandem consolidation of thiotepa/cyclophosphamide followed by carboplatin/etoposide/melphalan (CEM) as compared to single CEM consolidation.
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Comparison of Different Types of Surgery in Treating Patients With Stage IA Non-Small Cell Lung Cancer
OBJECTIVES: Primary - Compare the disease-free survival of patients with small (≤ 2 cm) peripheral stage IA non-small cell lung cancer undergoing lobectomy vs sublobar resection (wedge resection or segmentectomy). Secondary - Compare the overall survival of patients undergoing lobectomy vs sublobar resection.
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Comparison of MRI and Molecular Breast Imaging in Breast Diagnostic Evaluation
Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo.
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Comparison of Radiation Therapy Regimens in Combination With Chemotherapy in Treating Young Patients With Newly Diagnosed Standard-Risk Medulloblastoma
OBJECTIVES: Primary - Compare event-free and overall survival of pediatric patients (3 to 7 years of age) with newly diagnosed standard-risk medulloblastoma treated with standard-dose vs reduced-dose craniospinal radiotherapy and posterior fossa boost vs tumor bed boost radiotherapy in combination with chemotherapy comprising vincristine, cisplatin, lomustine, and cyclophosphamide.
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Cyclophosphamide, Carfilzomib, Thalidomide, and Dexamethasone in Treating Patients With Newly Diagnosed Active Multiple Myeloma
PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose of carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone. (Phase I) II. In newly diagnosed myeloma to evaluate the response rate (CR, nCR, and VGPR) to carfilzomib given in combination with oral cyclophosphamide and thalidomide and dexamethasone after four 28 day cycles.
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Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
OBJECTIVES: Primary - To determine the feasibility and toxicity of dasatinib in combination with intensified chemotherapy in young patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. - To determine whether the intensification of tyrosine kinase inhibition (TKI) through the addition of dasatinib to induction therapy (on days 15-28) and the substitution of dasatinib for imatinib mesylate during post-induction therapy will lead to a 3-year event-free
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Detection of Aggressive Breast Tumors Using Tc-99m-NC100692
The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.
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Dinaciclib in Treating Patients With Relapsed or Refractory Multiple Myeloma
OBJECTIVES: Primary - To evaluate the efficacy of single agent dinaciclib in patients with relapsed or refractory multiple myeloma. Secondary - To evaluate the toxicities associated with dinaciclib in these patients. - To evaluate the response duration and progression-free survival among these patients.
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Docetaxel and Prednisone With or Without Vaccine Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
OBJECTIVES: Primary - To evaluate the overall survival of patients with castrate-resistant, metastatic prostate cancer treated with docetaxel and prednisone with versus without vaccine therapy comprising vaccinia-PSA(L155)-TRICOM and fowlpox-PSA(L155)-TRICOM. Secondary - To evaluate the time to radiographic progression in patients treated with these regimens.
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Docetaxel, Oxaliplatin, Capecitabine, Fluorouracil, and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
OBJECTIVES: Primary - Assess and compare the pathologic complete response rate of sequential docetaxel, oxaliplatin, and capecitabine followed by fluorouracil, oxaliplatin, and radiotherapy versus fluorouracil, oxaliplatin, and radiotherapy alone in patients with potentially resectable advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia.
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Donor Stem Cell Transplant in Treating Young Patients With Acute Myeloid Leukemia With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory or Relapsed Acute Myelogenous Leukemia
OBJECTIVES: - To define the relationship between the status of donor NK-cell receptor and patient outcomes after killer immunoglobulin-like receptor-incompatible unrelated donor (URD) hematopoietic cell transplantation (HCT) in young patients with acute myeloid leukemia with monosomy 7, -5/5q-, high FLT3 internal tandem duplication allelic ratio (High-FLT3-ITD AR), or refractory or relapsed acute myelogenous leukemia.
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Dose Escalation Study of Hyperbaric Oxygen With Radiation and Chemotherapy to Treat Squamous Cell Carcinoma of the Head and Neck
The goal of this study is to see if patients can tolerate HBO therapy up to five days a week. Three patients in Arm 1 (HBO on Monday and Friday) will be observed throughout their course of concomitant radiation, chemo and hyperbaric therapy.
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Dose Escalation Study of Safety and Tolerability of AT-406 in Patients With Advanced Solid Tumors and Lymphomas
Ascenta Therapeutics, Inc. is conducting a clinical trial of the compound AT-406, a small molecule second mitochondria-derived activator of caspase C (Smac) mimetic. In vivo and in vitro studies have demonstrated that AT-406 induces cell death in several tumor models by inhibiting XIAP (X linked IAP), cIAP-1 (cellular IAP-1) and cIAP-2 (cellular IAP-2), thus releasing initiator and effector caspases to promote apoptosis.
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Dose Escalation Study to Determine Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous TKM-080301
This study will be a Phase I, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy.
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Dose-escalation Study of Oral CX-4945
Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth and overexpression of CK2 has been documented in multiple types of cancer. CK2 has emerged as a potential anticancer target and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers.
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Doxepin Hydrochloride in Treating Oral Mucositis Pain in Patients With Head and Neck Cancer Undergoing Radiation Therapy With or Without Chemotherapy
OBJECTIVES: Primary - Determine whether doxepin hydrochloride mouth rinse, compared to placebo, is effective in reducing oral mucositis-related pain in patients with head and neck cancer undergoing radiotherapy with or without chemotherapy. Secondary - Assess the adverse event profile of these regimens, using a patient-reported questionnaire at 5, 15, 30, 60, 120, and 240 minutes, in these patients.
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Early Increase in Blood Flow (EIBS) in the Duodenum in Patients With Pancreatic Cancer
The overall goal of this study is to test a technique that in the future may allow endoscopic detection of pancreatic neoplasia. The study is a single group, prospective, open label pilot study designed to assess the feasibility and efficacy of 4D-ELF in detecting EIBS in peri-ampullary duodenal mucosa in pancreatic cancer patients compared to control patients.
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Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer
OBJECTIVES: Primary - To evaluate whether early local therapy comprising surgery of intact primary disease compared to local palliative therapy only in patients with stage IV breast cancer, whose disease does not progress during initial optimal systemic therapy, will result in prolonged survival.
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Effect of Aromatase Inhibitor Therapy on Blood Vessel Function in Postmenopausal Women With Breast Cancer
OBJECTIVES: - Determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer. OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative).
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Effect of Surgery and Radiation Therapy on Tc-99M Sestamibi Uptake Patterns in Molecular Breast Imaging
The study will allow us to evaluate whether surgery and radiation have persistent effects on the breast tissue with regards to whether and how such changes impact MBI images and to determine whether the inflammatory changes due to treatment resolve within 6-12 months of completing treatment.
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Effectiveness of Aprepitant in Addition to Ondansetron in the Prevention of Nausea and Vomiting Caused by Upper Abdominal Radiotherapy
Severe nausea and/or vomiting in patients receiving radiotherapy to the upper abdomen is common despite having received pre-medication with ondansetron, a standard preventive treatment. This study aims to reduce the incidence of significant nausea and/or vomiting with the addition of the NK1-antagonist aprepitant to standard ondansetron treatment.
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Efficacy Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Platinum-Refractory Head and Neck Cancers
Squamous cell carcinoma of the head and neck is the sixth most common cancer in the world. More than 50% of patients diagnosed with advanced regional disease will relapse locally or at distant sites.
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Escalating Dose Study in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Bruton's tyrosine kinase (Btk) is non-receptor tyrosine kinase with restricted cellular expression largely limited to B-lymphocytes, monocytes, and mast cells or basophils. Btk is a critical component of the B cell receptor (BCR) signaling network and is crucial for B cell development.
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Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane Adjuvant Therapies for Pre-Menopausal Women with Endocrine Responsive Breast Cancer (IBCSG 24-02)
This research study is being done to:

• see if ovarian function suppression [OFS] plus giving tamoxifen or exemestane is better at stopping the return of breast cancer than just giving tamoxifen in pre-menopausal women.
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  Evaluation of SAMe for Hot Flashes
  OBJECTIVES: I. To evaluate the impact of SAMe on hot flash scores in women with a history of breast cancer or women who do not wish to take estrogen therapy for fear of increased risk of breast cancer.
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  Everolimus and Alemtuzumab in Treating Patients With Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  PRIMARY OBJECTIVES: I. Test the safety and tolerability of the combination of everolimus and alemtuzumab. (Phase I) II. Determine the maximum tolerated dose of everolimus in this combination. (Phase I) III. Assess the rate of overall responses in patients with relapsed/refractory CLL to treatment with the maximum tolerated dose of everolimus together with a standard dose of alemtuzumab using conventional NCI-WG 1996 response criteria.
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  Everolimus and Gemcitabine Hydrochloride in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
  OBJECTIVES: I. To determine the maximally tolerated dose of concurrently administered RAD001 and gemcitabine in patients with advanced, refractory solid tumors. II. To describe the toxicity of the treatment combination. III. To describe any evidence of the antitumor activity of the treatment combination.
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  Everolimus and Lenalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin or Hodgkin Lymphoma
  PRIMARY OBJECTIVES: I. To establish the maximum tolerated dose of RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma. (Phase I) II. To assess tumor response to RAD001 and lenalidomide in subjects with relapsed/refractory Non-Hodgkin Lymphoma or Hodgkin Lymphoma.
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  Everolimus, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
  OBJECTIVES: - To determine the maximum tolerated dose (MTD) of everolimus in combination with temozolomide and 3D-conformal radiotherapy or intensity-modulated radiotherapy (IMRT) followed by adjuvant temozolomide with or without everolimus in patients with newly diagnosed glioblastoma.
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  Familial Barrett's Esophagus
  This research study is trying to determine whether Barrett's esophagus and associated esophageal cancers, specifically esophageal adenocarcinoma are inherited in certain families. Persons who are affected with Barrett's esophagus or esophageal cancer (adenocarcinoma type) are asked to complete a questionnaire that determines their habits and asks a detailed family history.
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  Family Study of Lymphoproliferative Disorders
  Blood and lymph node cancers can begin in either the lymphatic tissues (as in the case of lymphoma) or in the bone marrow (as with leukemia and myeloma), and they all are involved with the uncontrolled growth of white blood cells.
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  Fludeoxyglucose F 18-PET/CT Imaging in Assessing the Tumor and Planning Neck Surgery in Patients With Newly Diagnosed Head and Neck Cancer
  OBJECTIVES: Primary - Determine the negative predictive value of PET/CT imaging based upon pathologic sampling of the neck lymph nodes in patients with head and neck cancer planning to undergo N0 neck surgery.
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  Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma
  PRIMARY OBJECTIVES: I. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies. II. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.
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  GDC-0449 and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery
  OBJECTIVES: Primary - To determine the maximum tolerated dose of erlotinib hydrochloride and Hedgehog antagonist GDC-0449 with or without gemcitabine hydrochloride in patients with unresectable solid tumors. Secondary - To describe the adverse events profile associated with these treatment regimens.
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  Gemcitabine and Erlotinib Before and After Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
  OBJECTIVES: Primary - To estimate the proportion of patients with resectable adenocarcinoma of the pancreas alive at 2 years from the date of study registration after treatment with neoadjuvant and adjuvant gemcitabine hydrochloride and erlotinib hydrochloride plus pancreatectomy.
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  Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer
  OBJECTIVES: Primary - Compare the overall survival of patients with advanced transitional cell carcinoma of the urinary tract treated with gemcitabine hydrochloride, cisplatin, and bevacizumab vs gemcitabine hydrochloride, cisplatin, and placebo. Secondary - Compare the progression-free survival of patients treated with these regimens.
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  Gemcitabine Hydrochloride and Docetaxel With or Without Bevacizumab in Treating Patients With Advanced or Recurrent Uterine Leiomyosarcoma
  OBJECTIVES: Primary - To determine whether the addition of bevacizumab to fixed-dose rate gemcitabine hydrochloride and docetaxel reduces the progression-free survival event rate when compared with gemcitabine hydrochloride and docetaxel plus placebo in patients with advanced or recurrent uterine leiomyosarcoma (LMS).
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  Gemcitabine Hydrochloride With or Without Erlotinib Hydrochloride Followed By the Same Chemotherapy Regimen With or Without Radiation Therapy and Capecitabine or Fluorouracil in Treating Patients With Pancreatic Cancer That Has Been Removed By Surgery
  OBJECTIVES: Primary - To determine whether the addition of erlotinib hydrochloride to adjuvant chemotherapy comprising gemcitabine hydrochloride improves survival as compared to gemcitabine hydrochloride alone following R0 or R1 resection in patients with pancreatic adenocarcinoma.
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  Gemtuzumab and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
  OBJECTIVES: - To assess the event-free survival and death during the first six weeks in patients with previously untreated, high-risk acute promyelocytic leukemia treated with a combined regimen of tretinoin, arsenic trioxide, and gemtuzumab ozogamicin.
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  Gene Analysis for the Understanding of Barrett's Esophagus and Esophagus Cancer
  This study is being done to advance the understanding of how esophagus cancer and Barrett's Esophagus develop as well as ways to treat these conditions. This will be done by analyzing blood and tissue to identify genes that may be involved in the development of esophagus cancer and Barrett's Esophagus.
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  Gene Therapy and Radioactive Iodine in Treating Patients With Locally Recurrent Prostate Cancer That Did Not Respond to External-Beam Radiation Therapy
  OBJECTIVES: Primary - To determine the safety and tolerance of Ad5CMV-NIS administered intraprostatically followed by radioiodine treatment in patients with locally recurrent adenocarcinoma of the prostate following external beam radiotherapy. - To determine the maximum tolerated dose of Ad5CMV-NIS in these patients.
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  Genetics Study for Women with Breast Cancer and Starting Anastrozole (Arimidex) Treatment (MC0532)
  This study is being done to examine how a woman's genes affect the way her body responds to anastrozole treatment. Researchers will look at changes in hormone levels, bone density and mammograms.
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  Gliogene: Brain Tumor Linkage Study
  A consortium (group) of researchers wants to learn more about gliomas as well as the risk factors (such as environmental and genetic information) for patients with this kind of brain tumor. Participants in this study will be part of a glioma genetic epidemiology study (herein referred to as "GLIOGENE") involving eleven centers in the United States (U.S.)
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  Glutamic Acid in Reducing Nerve Damage Caused by Vincristine in Young Patients Receiving Vincristine for Wilms' Tumor, Rhabdomyosarcoma, Acute Lymphoblastic Leukemia, or Non-Hodgkin's Lymphoma
  OBJECTIVES: Primary - Compare the effect of glutamic acid vs placebo, in terms of decreasing neurotoxicity as measured by a scored neurologic examination, in young patients undergoing vincristine-containing treatment for Wilms' tumor, rhabdomyosarcoma, acute lymphoblastic leukemia, or non-Hodgkin's lymphoma.
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  Gold Sodium Thiomalate in Treating Patients With Advanced Non-Small Cell Lung Cancer
  OBJECTIVES: - To determine the maximum tolerated dose of gold sodium thiomalate in patients with advanced non-small cell lung cancer. - To describe the toxicities associated with this treatment. - To describe any preliminary evidence of biologic activity.
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  Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery
  OBJECTIVES: Primary - To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid. Secondary - To evaluate the safety of this drug in these patients.
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  Higher-Dose Radiation Therapy or Standard Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
  OBJECTIVES: Primary - To determine whether an accelerated course of hypofractionated whole-breast irradiation (WBI) including a concomitant boost to the tumor bed in 15 fractions following lumpectomy will prove to be non-inferior in local control to a regimen of standard WBI with a sequential boost following lumpectomy for early-stage breast cancer patients.
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  Home-Based Programs for Improving Sleep in Cancer Survivors
  OBJECTIVES: Primary - To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake disturbances,as measured by sleep latency or time to fall back asleep after initial sleep onset per sleep diaries, at baseline (week 1) and at the end of week 7 in cancer survivors.
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  I-SPY 2 TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
  I-SPY 2 will compare the efficacy of novel drugs in combination with standard chemotherapy with the efficacy of standard therapy alone. The goal is identify improved treatment regimens for subsets on the basis of molecular characteristics (biomarker signatures) of their disease.
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  Imaging of Radiolabeled White Blood Cells in Patients With Non-Hodgkin's Lymphoma
  OBJECTIVES: - Determine the number of indium In 111-labeled peripheral blood mononuclear cells (PBMCs) and indium In 111-labeled polymorphonuclear leukocytes (PMNLs) trafficking into lymphoma tumors prior to therapy in patients with non-Hodgkin's lymphoma.
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  Imatinib Mesylate in Treating Patients With Recurrent Brain Tumor
  OBJECTIVES: - Determine the maximum tolerated dose of imatinib mesylate in patients with recurrent oligodendroglioma or mixed oligoastrocytoma who are currently on enzyme-inducing anticonvulsant therapy. (Phase I) - Determine the efficacy of imatinib mesylate, as measured by response, survival, and progression-free survival, in patients with recurrent oligodendroglioma or mixed oligoastrocytoma.
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  Immunotherapy Study for Surgically Resected Pancreatic Cancer
  Unfortunately, despite the best clinical efforts and breakthroughs in biotechnology, most patients diagnosed with pancreatic cancer continue to die from the rapid progression of their disease. The primary reason for this is that the disease is typically without symptoms until significant local and/or distant spread has occurred and is often beyond the chance for cure at the time of the diagnosis.
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  Imprime PGG, Alemtuzumab, and Rituximab in Treating Patients With High Risk Chronic Lymphocytic Leukemia
  PRIMARY OBJECTIVES: I. Determine the maximum tolerated dose of PGG beta glucan in combination with alemtuzumab and rituximab. (Phase I) II. Assess the rate of complete response of patients with high-risk, early-intermediate stage CLL who are treated with alemtuzumab, rituximab, and PGG beta glucan before meeting standard National Cancer Institute-International Workshop on Chronic Lymphocytic Leukemia (NCI-IWCLL) criteria (Hallek, Cheson et al.
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  Incidence of Cancer in Women at Increased Genetic Risk of Ovarian Cancer
  OBJECTIVES: - To determine the prospective incidence of ovarian cancer, fallopian tube cancer, breast cancer, primary peritoneal cancer, and all cancer among women at increased risk of ovarian cancer, with a special emphasis on women who are known BRCA1/2 mutation carriers.
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  Individualized Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
  PRIMARY OBJECTIVES: I. To assess the clinical activity of timed administration of TMZ therapy in patients with stage IV melanoma who have or have not received prior chemotherapy for metastatic melanoma. SECONDARY OBJECTIVES: I.
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  Inositol in Preventing Lung Cancer in Current or Former Smokers With Bronchial Dysplasia
  OBJECTIVES: Primary - To compare the efficacy of inositol vs placebo in reverting bronchial dysplasia in current or former smokers. Secondary - To further define the mechanism(s) of action of pharmacological doses of inositol as a lung cancer chemopreventive agent by evaluating changes in the number of dysplastic lesions and Ki-67, caspase-3, PPAR gamma, cyclin D1, cyclin E, VEGF, EGFR, NF-kappa B, and STAT3 immunostaining in
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  Intensive Treatment for Intermediate-Risk Relapse of Childhood B-Precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies
  Patients have been treated in the past for a cancer of the blood cells called acute lymphoblastic leukemia (ALL). Patients are being asked to take part in this study because the leukemia has come back (relapsed) and is of intermediate risk.
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  Interstitial Brachytherapy With or Without External-Beam Radiation Therapy in Treating Patients With Prostate Cancer
  OBJECTIVES: - Compare the 5-year freedom from progression in patients with intermediate-risk prostate cancer treated with interstitial brachytherapy with or without external beam radiotherapy (EBRT). - Compare biochemical (i.e., prostate-specific antigen) failure, biochemical failure by the Phoenix definition, disease-specific survival, local progression, and distant metastases in patients treated with these regimens.
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  Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand
  Prognosis for many carcinomas, including ovarian carcinoma, is dependent on a complete surgical resection, also known as a R0 resection. At present, the ability to perform a complete resection with negative margins is limited by the surgeon's ability to palpate and visualize the tumor and its margins.
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  Intrapleural Measles Virus Therapy in Patients With Malignant Pleural Mesothelioma
  PRIMARY OBJECTIVES: Maximum tolerated dose (MTD) for the intrapleural administration of a modified vaccine strain measles virus (MV) genetically engineered to produce human thyroidal sodium iodine symporter (NIS) (MV-NIS [oncolytic measles virus encoding thyroidal sodium iodide symporter])in patients with MPM.
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  Ipilimumab or High-Dose Interferon Alfa-2b in Treating Patients With High-Risk Stage III or Stage IV Melanoma That Has Been Removed by Surgery
  OBJECTIVES: Primary - To evaluate recurrence-free survival (RFS) between patients randomized to receive post-operative adjuvant ipilimumab versus those randomized to receive high-dose recombinant interferon alfa-2b (HDI). - To evaluate overall survival (OS) between patients randomized to receive pos-toperative adjuvant ipilimumab versus those randomized to receive HDI.
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  Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
  OBJECTIVES: Primary - Assess the confirmed tumor response in patients with metastatic or unresectable locally advanced adenocarcinoma of the small bowel treated with irinotecan hydrochloride, oxaliplatin, and capecitabine when dosed according to UGT1A1 genotype.
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  Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma
  OBJECTIVES: Primary - Compare the event-free survival of patients with neuroblastoma who have completed myeloablative therapy and autologous stem cell transplantation (ASCT) when treated with adjuvant isotretinoin with or without monoclonal antibody Ch14.18,
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  Ixabepilone and Temsirolimus in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
  OBJECTIVES: - To determine the maximum-tolerated dose (MTD) of the combination of ixabepilone and temsirolimus in patients with advanced solid tumors. - To describe toxicity profiles associated with the combination of ixabepilone and temsirolimus.
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  Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Stage IIA, Stage IIIA, or Stage IIIB Rectal Cancer
  OBJECTIVES: Primary - To test the hypothesis that laparoscopic-assisted resection is not inferior to open resection, based on a composite primary endpoint of oncologic factors that are indicative of a safe and feasible surgical resection, in patients with stage IIA, IIIA, or IIIB rectal cancer.
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  Lapatinib in Treating Women With Ductal Carcinoma In Situ of the Breast
  OBJECTIVES: Primary - Determine the minimal biologic dose of lapatinib ditosylate, defined as the smallest dose, when compared with placebo, that results in a statistically significant lower rate of proliferation in ductal carcinoma in situ (DCIS) breast cancer cells as measured by Ki67.
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  Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma
  OBJECTIVES: Primary - To compare progression-free survival of patients with newly diagnosed multiple myeloma treated with lenalidomide and low-dose dexamethasone with or without bortezomib. Secondary - To assess response using the new international response criteria.
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  Lenalidomide and Low-Dose Dexamethasone in Patients With Previously Treated Multiple Myeloma and Kidney Dysfunction
  Multiple Myeloma (MM) affects approximately 20,000 Americans annually and remains an incurable hematologic malignancy characterized by frequent early response followed by universal treatment relapse necessitating multiple sequential therapeutic regimens. Until recently, few effective therapies existed.
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  Lenalidomide With or Without Epoetin Alfa in Treating Patients With Myelodysplastic Syndrome and Anemia
  OBJECTIVES: Primary - To compare the rate of major erythroid response (MER) in patients with low- or intermediate-1-risk myelodysplastic syndromes treated with lenalidomide with vs without epoetin alfa. Secondary - To compare the time to MER in patients treated with these regimens.
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  Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma
  OBJECTIVES: Primary - To determine the maximum tolerated dose of lenalidomide when given in combination with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone in patients with newly diagnosed stage II-IV diffuse large cell or grade 3 follicular B-cell lymphoma.
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  Lenalidomide, Rituximab, Cyclophosphamide, and Dexamethasone in Treating Patients With Previously Untreated Low-Grade Non-Hodgkin Lymphoma
  OBJECTIVES: Primary - To assess tumor response to lenalidomide, rituximab, cyclophosphamide, and dexamethasone in patients with symptomatic previously untreated low-grade non-Hodgkin lymphoma. Secondary - To describe the adverse event profile of this regimen. - To evaluate overall survival, progression-free survival, duration of response, and time to treatment failure associated with this regimen.
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  Letrozole in Treating Healthy Postmenopausal Women at High Risk for Breast Cancer
  OBJECTIVES: Primary - To compare the effect of lower and intermittent doses of letrozole to standard letrozole therapy on estrogen suppression in postmenopausal women at high risk for developing breast cancer. Secondary - To compare the effect of lower and intermittent doses of letrozole to standard therapy on signs and symptoms of estrogen deficiency, including menopausal symptoms, serum lipid profile, and serum marker bone turnover.
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  Leuprolide Acetate or Goserelin Acetate Compared With Observation in Treating Patients With High-Risk Prostate Cancer Who Have Undergone Radical Prostatectomy
  PRIMARY OBJECTIVES: I. To compare the difference in the biochemical progression-free survival rate (bPFS) at 2-years between immediate ADT for nine months in high risk prostate cancer patients following radical prostatectomy and a similar high risk patient population followed without initiation of immediate ADT treatment.
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  Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies
  OBJECTIVES: - To develop a mechanism for tracking and retaining patients enrolled on COG protocols. - To maintain regular, lifetime contact with patients in order to obtain current identification and contact information, and self/parent-reported health status.
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  Longer-term Recurrence Rates in Patients With Bladder Cancer After Hexvix (Cysview)Fluorescence Cystoscopy/TURB
  A previously completed pivotal clinical study PC B305/04 demonstrated reduced recurrence rates for patients with papillary bladder cancer who underwent Hexvix (Cysview) and white light cystoscopy and transurethral resection (TURB) of the bladder compared to patients who underwent white light cystoscopy and TURB alone.
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  Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia
  OBJECTIVES: Primary - Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia. Secondary - Compare the 3-year event-free survival and frequency and severity of adverse effects in patients treated with high-dose (closed to accrual as of 9/2010) vs low-dose vincristine.
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  Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
  OBJECTIVES: - Identify surrogate markers of response to neoadjuvant chemotherapy by contrast-enhanced magnetic resonance imaging (MRI) that are predictive of pathologic remissions and survival in women with stage III breast cancer. - Identify two groups of patients who have statistically different 3-year disease-free survival using MRI measurements of tumor response to neoadjuvant chemotherapy.
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  Melphalan and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Systemic Light-Chain Amyloidosis
  OBJECTIVES: Primary - To compare hematologic overall response (partial response [PR], very good PR, amyloid complete hematologic response [ACR], and stringent complete response [sCR]) after 3 courses of therapy in patients with previously untreated systemic light-chain amyloidosis treated with melphalan and dexamethasone with vs without bortezomib.
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  Melphalan, Prednisone, and Thalidomide or Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
  OBJECTIVES: Primary - To compare progression-free survival between patients receiving melphalan, prednisone, and thalidomide versus melphalan, prednisone, and lenalidomide in newly diagnosed multiple myeloma patients who are not candidates for high-dose therapy. Secondary - To compare overall survival between both arms.
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  MLN8237 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Leukemia
  OBJECTIVES: Primary - To determine the objective response rate in pediatric patients with relapsed or refractory solid tumors or leukemia treated with aurora A kinase inhibitor alisertib (MLN8237). Secondary - To define and describe the toxicities of this regimen in these patients.
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  Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
  The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (~90%) for the detection of breast cancers independent of breast density.
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  Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer
  Patients who are at average risk of developing colorectal cancer who are eligible for colorectal cancer screening will be asked to collect a single stool sample for the Exact CRC screening test and for the commercially available FIT assay.
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  Multiple Ascending Dose (MDX1105-01)
  This is an open label, multicenter, dose escalation and multidose study of MDX-11-5, a fully human monoclonal IgG4 antibody targeting the Programed Death-Ligand 1 (PD-L1). The study will consist of 3 periods: Screening (up to 28 days), Treatment (up to 16 six-week cycles), and Follow-up (up to 6 months).
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  Multiple Ascending Dose of BMS-911543
  The purpose of this first in human study is to determine if BMS-911543 is safe and tolerable in subjects with symptomatic intermediate-1, intermediate-2 or high risk myelofibrosis to permit clinical testing at the Maximum Tolerated Dose or at a Clinically Active Dose, and to determine if BMS-911543 will demonstrate efficacy in symptomatic myelofibrosis.
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  Neuropsychological and Behavioral Testing in Young Patients With Medulloblastoma or Supratentorial Primitive Neuroectodermal Tumor (PNET)
  OBJECTIVES: - To institute procedures to ensure a consistent, streamlined, and efficient administration of the neuropsychological and behavioral tests in a cooperative group setting in order to maximize compliance with a standardized assessment battery conducted at 3 standardized time points in children with medulloblastoma or supratentorial primitive neuroectodermal tumor (PNET).
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  Obatoclax and Bortezomib in Treating Patients With Relapsed or Refractory Multiple Myeloma
  OBJECTIVES: Primary - To determine the maximum tolerated dose and recommended phase II dose of obatoclax mesylate when given in combination with bortezomib in patients with relapsed or refractory multiple myeloma. (Phase I) - To evaluate the response rate (complete response, partial response, and very good partial response) in patients treated with this regimen.
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  Octreotide and Interferon Alfa-2b or Bevacizumab in Treating Patients With Metastatic or Locally Advanced, High-Risk Neuroendocrine Tumor
  OBJECTIVES: - To compare central review-based progression-free survival (PFS) in poor prognosis carcinoid patients treated with either depot octreotide acetate plus bevacizumab or depot octreotide acetate plus interferon. - To compare overall survival, time to treatment failure, and traditionally reported progression-free survival of poor prognosis carcinoid patients treated with either depot octreotide acetate plus bevacizumab or depot octreotide acetate plus interferon.
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  Ofatumumab, Pentostatin, and Cyclophosphamide in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  PRIMARY OBJECTIVES: I. Arm A: To assess the rate of complete response using pentostatin, cyclophosphamide, and ofatumumab in patients with previously untreated CLL or SLL requiring therapy. II. Arm B: To assess the treatment-free survival rate at 18 months using pentostatin,cyclophosphamide, and ofatumumab induction therapy followed by ofatumumab consolidation in patients with previously untreated CLL or SSLL requiring therapy.
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  Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
  OBJECTIVES: Primary - To compare disease-free survival of patients with resected stage III colon cancer treated with adjuvant FOLFOX chemotherapy comprising oxaliplatin, fluorouracil, and leucovorin calcium with versus without celecoxib. Secondary - To contribute to an international prospective pooled analysis comparing disease-free survival of patients treated with these regimens.
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  Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed Persistent or Recurrent Uterine or Ovarian Cancer
  OBJECTIVES: Primary - To determine if treatment with paclitaxel and carboplatin does not result in an inferior death rate when compared to paclitaxel and ifosfamide in chemotherapy-naïve patients with newly diagnosed stage I-IV persistent or recurrent uterine or ovarian carcinosarcoma.
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  Paclitaxel and Cisplatin or Topotecan With or Without Bevacizumab in Treating Patients With Stage IVB, Recurrent, or Persistent Cervical Cancer
  OBJECTIVES: Primary - To compare the overall survival of patients with stage IVB, recurrent, or persistent carcinoma of the cervix treated with paclitaxel in combination with cisplatin or topotecan with vs without bevacizumab.
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  Paclitaxel or Polyglutamate Paclitaxel or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Peritoneal Cancer or Fallopian Tube Cancer
  OBJECTIVES: Primary - Compare overall survival of patients with stage III or IV ovarian epithelial or primary peritoneal cancer or fallopian tube cancer in clinical complete response after prior primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until documented disease progression.
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  Paclitaxel With or Without Cixutumumab as Second-Line Therapy in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer
  OBJECTIVES: Primary - To evaluate the progression-free survival of patients with metastatic esophageal or gastroesophageal junction cancer treated with paclitaxel with versus without cixutumumab as second-line therapy. Secondary - To evaluate the overall survival of patients treated with these regimens.
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  Paclitaxel, Carboplatin, and Bevacizumab or Paclitaxel, Carboplatin, and Temsirolimus or Ixabepilone, Carboplatin, and Bevacizumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
  OBJECTIVES: Primary - To estimate the hazard of progression or death of each treatment with paclitaxel, carboplatin, and bevacizumab vs paclitaxel, carboplatin, and temsirolimus vs ixabepilone, carboplatin, and bevacizumab relative to that of historical controls in patients with advanced or recurrent endometrial cancer.
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  Paclitaxel, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer
  OBJECTIVES: Primary - To compare the progression-free survival of patients with stage IIIC or IV breast cancer treated with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) versus ixabepilone versus paclitaxel with or without bevacizumab. Secondary - To compare the objective response rate, duration of response, and time to treatment failure in patients receiving nab-paclitaxel versus paclitaxel, and to separately compare these endpoints in patients receiving ixabepilone versus paclitaxel.
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  Panitumumab, Docetaxel, Cisplatin, Radiation Therapy, and Surgery in Treating Patients With Newly Diagnosed, Locally Advanced Esophageal Cancer or Cancer of the Gastroesophageal Junction
  OBJECTIVES: Primary - To determine the pathologic complete response rate in patients with newly diagnosed, locally advanced adenocarcinoma of the distal esophagus or gastroesophageal junction treated with neoadjuvant panitumumab and combination chemoradiotherapy followed by surgery.
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  Panobinostat and Everolimus in Treating Patients With Recurrent Multiple Myeloma, Non-Hodgkin Lymphoma, or Hodgkin Lymphoma
  PRIMARY OBJECTIVES: I. To determine the maximum tolerated doses (MTD) of LBH589 and RAD001 when used in combination in patients with myeloma or lymphoma (Phase I). II. Arm A: To evaluate the therapeutic activity of the combination of LBH589 with RAD001 in patients with relapsed or refractory lymphoma.
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  Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
  PRIMARY OBJECTIVES: I. To evaluate the proportion of confirmed response of LBH589 in patients with relapsed or refractory non-Hodgkin lymphoma. SECONDARY OBJECTIVES: I. To describe the toxicities associated with LBH589 in patients with NHL.
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  Participation in Procurement of Tissue, Serum, Plasma, Cell Bank, DNA and RNA Samples, and Urine for Biological Studies Related to Prostate Cancer and Prostate Cancer Treatment Follow Up
  This research study is being done to collect regular and routine follow-up information related to the outcome of treatment for prostate cancer. This study is also being done to relate treatment outcome to measurement of substances in the blood such as prostate-specific antigen (PSA) and other markers.
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  Pazopanib Hydrochloride in Treating Patients With Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma
  OBJECTIVES: Primary - To assess the antitumor activity (in terms of the tumor response rate using the RECIST criteria) of pazopanib in patients with advanced malignant pheochromocytomas or paragangliomas. Secondary - To assess the safety profile of pazopanib in patients with advanced malignant pheochromocytomas or paragangliomas.
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  Pazopanib in Treating Patients With Advanced Thyroid Cancer
  OBJECTIVES: Primary - To establish the safety and efficacy of pazopanib hydrochloride in patients with differentiated, medullary, or anaplastic thyroid cancer. Secondary - To assess the impact of pazopanib hydrochloride on serum and plasma VEGF levels.
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  Pemetrexed Disodium or Observation in Treating Patients With Malignant Pleural Mesothelioma Without Progressive Disease After First-Line Chemotherapy
  OBJECTIVES: Primary - To determine if maintenance therapy with pemetrexed disodium versus observation improves progression-free survival of patients with malignant pleural mesothelioma who have at least stable disease after completion of first-line therapy comprising pemetrexed disodium with cisplatin or carboplatin.
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  Pentostatin, Alemtuzumab, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  OBJECTIVES: Primary - To assess the rate of complete and overall response in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma treated with pentostatin, alemtuzumab, and low-dose rituximab. - To assess response to this treatment regimen using an expanded definition of response, including CT scans of chest-abdomen-pelvis, immunohistochemical analysis for residual disease in the bone marrow, and sensitive flow cytometry for minimal
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  Pentostatin, Cyclophosphamide, and Rituximab With or Without Bevacizumab in Treating Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  OBJECTIVES: Primary - To assess the rate of complete and overall response in patients with B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma treated with pentostatin, cyclophosphamide, and rituximab with or without bevacizumab.
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  Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors
  This study is being done to: - Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer; - Find the highest dose of EP-100 that can be given without causing bad side effects; - Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of
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  Phase 1/2 Safety and Tolerability Study of SNS01-T in Relapsed or Refractory Multiple Myeloma
  The main purpose is to test the safety and tolerability of SNS01-T. The first group of patients with relapsed or refractory multiple myeloma will be given a relatively low dose. If tolerated, a second group will receive a higher dose.
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  Phase 3 Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Versus Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
  This is a Phase 3, randomized, open-label, multicenter study comparing two treatment regimens for subjects with relapsed multiple myeloma. Eligible subjects will be randomized in a 1:1 ratio to receive either the control Rd or CRd.
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  Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
  The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
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  Phase 3 Study of ThermoDox With Radiofrequency Ablation (RFA) in Treatment of Hepatocellular Carcinoma (HCC)
  This will be a Phase III, randomized, double-blinded, dummy-controlled, efficacy, and safety study of ThermoDox plus RFA versus RFA plus dummy infusion. The 50 mg/m2 ThermoDox or dummy infusion will be administered IV over 30 minutes.
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  Phase III Lucanix™ Vaccine Therapy in Advanced Non-small Cell Lung Cancer (NSCLC) Following Front-line Chemotherapy
  Primary Efficacy Endpoints: - Compare the overall survival of subjects with stage III or IV non-small cell lung cancer treated with belagenpumatucel-L (Lucanix™) vs placebo. Secondary Efficacy Endpoints: - Evaluate the progression free survival (PFS) of subjects treated with Lucanix™ compared to treatment within the BSC control group.
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  Phase III Study of ABI-007(Albumin-bound Paclitaxel) Plus Gemcitabine Versus Gemcitabine in Metastatic Adenocarcinoma of the Pancreas
  A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and PFS in patients diagnosed with metastatic adenocarcinoma of the pancreas.
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  Phase III Study of RAD001 Adjuvant Therapy in Poor Risk Patients With Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 Versus Matching Placebo After Patients Have Achieved Complete Response With First-line Rituximab-chemotherapy
  Phase III study of RAD001 adjuvant therapy in poor risk patients with Diffuse Large B-Cell Lymphoma (DLBCL) of RAD001 versus matching placebo after patients have achieved complete response with first-line rituximab-chemotherapy
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  Pioglitazone Hydrochloride in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer
  OBJECTIVES: Primary - To evaluate the mechanism(s) of action of pioglitazone hydrochloride (pioglitazone) as a candidate chemopreventive agent for lung cancer by investigating the effects on Ki-67 defined in non-small cell lung cancer (NSCLC) tumor tissue.
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  Pixantrone Dimaleate in Treating Patients With HER2-Negative Metastatic Breast Cancer
  OBJECTIVES: Primary - To assess the proportion of confirmed tumor responses in patients with HER2-negative metastatic breast cancer treated with pixantrone dimaleate. Secondary - To describe the distribution of progression-free survival (PFS) times of patients treated with this drug.
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  Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
  OBJECTIVES: Primary - To determine the effectiveness of two doses of daily vaginal prasterone (dehydroepiandrosterone [DHEA]) versus placebo for alleviation of the most bothersome vaginal symptom (vaginal dryness or dyspareunia) over 12 weeks.
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  Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising PSA After Surgery for Prostate Cancer
  OBJECTIVES: Primary - To determine whether the addition of short-term androgen deprivation (STAD) to prostate bed radiotherapy (PBRT) improves freedom from progression (FFP) (i.e., maintenance of a prostate-specific antigen [PSA] less than the nadir+2 ng/mL, absence of clinical failure, and absence of death from any cause) for 5 years, over that of PBRT alone in men treated with salvage radiotherapy after radical prostatectomy.
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  Radiation Therapy and Cisplatin in Treating Patients With Stage I Bladder Cancer
  OBJECTIVES: Primary - To evaluate the rate of freedom from radical cystectomy at 3 years. Secondary - To evaluate the rate of freedom from radical cystectomy at 5 years. - To evaluate the rate of freedom from the development of distant disease progression at 3 and 5 years.
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  Radiation Therapy With or Without Androgen-Deprivation Therapy in Treating Patients With Prostate Cancer
  OBJECTIVES: Primary - Demonstrate an overall survival (OS) advantage in patients with intermediate-risk prostate cancer treated with dose-escalated radiotherapy (RT) with versus without short-term androgen-deprivation therapy (ADT). Secondary - Determine whether the addition of ADT to dose-escalated RT versus RT alone improves clinical failures, biochemical failure by the "nadir +2", freedom from failure, rate of salvage ADT, and prostate cancer-specific mortality in these patients.
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  Radiation Therapy With or Without Chemotherapy in Patients With Stage I or Stage II Cervical Cancer Who Previously Underwent Surgery
  OBJECTIVES: Primary - To determine if post-operative adjuvant chemoradiotherapy (CRT) can significantly improve recurrence-free survival (RFS) when compared to radiation therapy (RT) alone in patients with intermediate-risk factors stage I-IIA cervical cancer after treatment with radical hysterectomy.
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  Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma
  OBJECTIVES: Primary - To determine whether the addition of temozolomide to fractionated radiotherapy improves the progression-free survival (PFS) of patients with symptomatic or progressive low-grade gliomas. - To determine whether the addition of temozolomide to fractionated radiotherapy improves the median overall survival (OS) of these patients.
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  Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
  OBJECTIVES: Primary - Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine. Secondary - Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.
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  Radiation Therapy, Paclitaxel, and Carboplatin With or Without Trastuzumab in Treating Patients With Esophageal Cancer
  OBJECTIVES: Primary - To determine whether trastuzumab increases disease-free survival when combined with radiotherapy, paclitaxel, and carboplatin followed by surgery in patients with HER2-overexpressing esophageal adenocarcinoma. Secondary - To evaluate whether the addition of trastuzumab to this neoadjuvant chemoradiation increases the pathologic complete response rate and overall survival of these patients.
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  Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
  This is a Phase III open-label, randomized, controlled, multicenter study (up to 50 centers). Approximately 270 patients with MDS classified as RAEB-1 and RAEB-2 using the WHO classification and as RAEB-t and chronic myelomonocytic leukemia (CMML) using the FAB classification who failed, became intolerant to, or progressed after treatment with 5-azacitidine or decitabine administered during the past 2 years, will be randomized in a
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  Recombinant Human Chorionic Gonadotropin in Preventing Breast Cancer in Premenopausal Women With BRCA1 Mutations
  OBJECTIVES: Primary - Determine whether the genomic profiles of breast epithelial cells of high-breast cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition, express a signature indicative of high-risk. Secondary - Determine whether women identified to express a "high-breast cancer-risk" signature will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which should have induced breast differentiation and genomic changes
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  Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer
  OBJECTIVES: - Determine the safety and toxicity of recombinant carcinoembryonic antigen (CEA)-expressing measles virus (MV-CEA) and oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) in patients with progressive, recurrent, or refractory ovarian epithelial or primary peritoneal cavity cancer ( MV-CEA closed as of 06/02/2008).
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  Reduced Intensity Conditioning Versus Myeloablative Conditioning for Acute Myeloid Leukemia or Myelodysplastic Syndrome (BMT CTN 0901)
  Patients randomized to RIC will receive one of two regimen types: the combination of fludarabine (120-180 mg/m^2) and busulfan (less than or equal to 8 mg/kg or IV equivalent) (Flu/Bu) or fludarabine (120-180 mg/m^2) and melphalan (less than 150 mg/m^2) (Flu/Mel).
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  Risk-Adapted Chemotherapy in Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia
  OBJECTIVES: Primary - To determine if a maintenance regimen containing once weekly oral methotrexate at 40 mg/m^2/week will result in an improved disease-free survival (DFS) compared to that containing weekly oral methotrexate at 20 mg/m^2/week in the average-risk (AR) subset of pediatric patients with standard-risk (SR) B-precursor acute lymphoblastic leukemia (ALL).
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  Risk-Based Classification System of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
  OBJECTIVES: - To provide a risk-based classification system based on clinical, pathological, molecular, and early response data that will be used to assign all patients with newly diagnosed acute lymphoblastic leukemia (ALL) to the Children's Oncology Group (COG) frontline specific-treatment studies.
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  Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
  OBJECTIVES: - Provide a classification guide that will organize the clinical and laboratory data necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (ALL) to a specific treatment clinical trial. - Provide an administrative base to capture classification data for correlative studies accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.
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  Rituximab and Alemtuzumab in Treating Older Patients With Progressive Chronic Lymphocytic Leukemia
  OBJECTIVES: Primary - To compare the rate of complete and overall response in elderly patients with progressive chronic lymphocytic leukemia (CLL) treated with one of two doses of rituximab combined with alemtuzumab to determine if the use of modified-dose rituximab significantly affects outcome.
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  Rituximab, Cladribine, and Temsirolimus in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
  OBJECTIVES: Primary - To assess the efficacy and safety of the combination of rituximab, cladribine, and temsirolimus in patients with newly diagnosed mantle cell lymphoma. - To determine the maximum tolerated dose of temsirolimus combined with a fixed dose and schedule of rituximab and cladribine in these patients.
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  Rituximab, Cyclophosphamide, Bortezomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Low-Grade Follicular Lymphoma, Waldenstrom Macroglobulinemia, or Mantle Cell Lymphoma
  OBJECTIVES: Primary - To assess tumor response in patients with relapsed or refractory low-grade follicular lymphoma (grade I or II), mantle cell lymphoma, or lymphoplasmacytic lymphoma (Waldenstrom macroglobulinemia) treated with rituximab, cyclophosphamide, bortezomib, and dexamethasone.
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  Rituximab, Yttrium Y 90 Ibritumomab Tiuxetan, Melphalan, and Autologous Peripheral Stem Cell Transplant in Treating Patients With Previously Treated Multiple Myeloma
  OBJECTIVES: Primary - Determine the safety of rituximab, yttrium Y 90 ibritumomab tiuxetan, high-dose melphalan, and autologous peripheral blood stem cell transplantation in patients with previously treated multiple myeloma. - Determine the effect of rituximab and yttrium Y 90 ibritumomab tiuxetan on the clonotypic B-cells at baseline and at B-cell recovery in these patients.
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  Safety and Efficacy of Cryoablation for Metastatic Lung Tumors
  ECLIPSE is a treatment, Phase 1 multicenter, prospective, single arm study with patients serving as their own control. This study is to enroll patients who will undergo cryoablation of at least 1 metastatic pulmonary tumor that is less than or equal to 3.5
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  Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Septic Shock
  To compare the safety and efficacy of the PMX cartridge based on mortality at 28-days in subjects with septic shock who have high levels of endotoxin and are treated with standard medical care plus use of the PMX cartridge, versus subjects who receive standard medical care alone.
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  Safety and Efficacy Study of PLX3397 in Adults With Relapsed or Refractory Hodgkin Lymphoma
  PLX3397 is a selective inhibitor of Fms, Kit, and oncogenic Flt3 activity.The primary objective of this study is to evaluate the efficacy, as measured by overall response rate, of orally administered PLX3397 in patients with relapsed or refractory classical Hodgkin lymphoma (HL).
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  Safety Study Evaluating Twice-Daily Administration of CYT387 in Primary Myelofibrosis or Post-Polycythemia Vera or Post-Essential Thrombocythemia Myelofibrosis
  The myeloproliferative neoplasms (MPN), most notably polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF) are a diverse but inter-related suite of clonal disorders of pluripotent hematopoietic stem cells (Tefferi et al.,
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  Scrambler Therapy in Treating Chronic Pain in Patients With Rash From Varicella Zoster Virus Infection
  PRIMARY OBJECTIVES: I. To explore whether we can decrease post-herpetic neuralgia (PHN) pain with scrambler therapy. OUTLINE: Patients undergo scrambler therapy for approximately 30 minutes. Treatment continues for 10 days in the absence of pain progression or unacceptable toxicity.
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  Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated With Chemotherapy
  OBJECTIVES: I. To record the types of patients that we treat, along with the reported efficacy and potential toxicity associated with scrambler therapy. II. To get experience with patient reported outcome measurement tools that we use in this trial, including a report of analgesic use.
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  Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
  OBJECTIVES: Primary - To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo. Secondary - To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
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  Short-Term Fasting Before Chemotherapy in Treating Patients With Cancer
  PRIMARY OBJECTIVES: I. To assess the safety and feasibility of short-term fasting prior to administration of chemotherapy. SECONDARY OBJECTIVES: I. To evaluate weight changes in patients who are exposed to short-term fasting prior to chemotherapy.
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  Single Versus Double Umbilical Cord Blood Transplantation in Children With High Risk Leukemia and Myelodysplasia
  BACKGROUND: In nearly every large single center or registry analysis of outcomes after UCB transplantation, cell dose is identified as an important factor influencing the incidence and rate of hematopoietic recovery, risk of transplant-related mortality, and probability of survival.
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  Sirolimus and Gold Sodium Thiomalate in Treating Patients With Advanced Squamous Non-Small Cell Lung Cancer
  PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of ATM (gold sodium thiomalate) plus sirolimus. SECONDARY OBJECTIVES: I. To describe the adverse event profile associated with this treatment combination. II.
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  Sorafenib and Everolimus in Treating Patients With Relapsed or Refractory Lymphoma or Multiple Myeloma
  OBJECTIVES: - Determine the maximum tolerated dose (MTD) of sorafenib tosylate and everolimus in patients with relapsed or refractory non-Hodgkin's lymphoma, Hodgkin's lymphoma, or multiple myeloma. - Determine the toxicity of this regimen in this patients.
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  Sorafenib and Temsirolimus in Treating Patients With Recurrent Glioblastoma
  OBJECTIVES: Primary - Establish a maximum tolerable dose of temsirolimus in combination with sorafenib in patients with recurrent glioblastoma not receiving enzyme-inducing anticonvulsants (EIACs). (Phase I [closed to accrual as of 11/21/07]) - Define the safety profile of temsirolimus and sorafenib in these patients.
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  Sorafenib Dose Ramp-Up in Hepatocellular Carcinoma (HCC)
  This is an open-label study that investigates the impact of a dose ramp-up strategy for sorafenib in patients with HCC. Clinical trial and post-marketing data suggest that sorafenib dose reductions and discontinuations due to adverse events are common and limit the drug's effectiveness.
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  Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer
  OBJECTIVES: Primary - To determine the maximum-tolerated dose of the combination of irinotecan hydrochloride, leucovorin calcium, and fluorouracil (FOLFIRI) plus sorafenib tosylate plus bevacizumab. Secondary - To assess the safety of FOLFIRI plus sorafenib tosylate plus bevacizumab.
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  Stage IV Surgery Versus Best Medical Therapy
  This study is designed to examine the impact of surgical resection versus medical therapy as initial treatment therapy for patients with Stage IV melanoma. Surgical resection is thought to be efficacious in highly selected patients with solitary metastases, but not in patients with multiple sites of metastases.
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  Stereotactic Body Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer
  OBJECTIVES: Primary - To determine the maximum tolerated dose (MTD) of stereotactic body radiotherapy (SBRT) in medically inoperable patients with centrally located stage I non-small cell lung cancer. (Phase I) - To determine the efficacy of SBRT when administered at the MTD in these patients.
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  Stereotactic Radiation Therapy With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
  OBJECTIVES: Primary - Compare the overall survival of patients with 1 to 3 cerebral metastases treated with stereotactic radiosurgery with vs without whole-brain radiotherapy. Secondary - Compare time to CNS (brain) failure in patients treated with these regimens.
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  Stereotactic Radiosurgery or Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases That Have Been Removed By Surgery
  OBJECTIVES: Primary - To ascertain in patients with one to four brain metastases whether there is improved overall survival in patients who receive stereotactic radiosurgery (SRS) to the surgical bed compared to patients who receive whole-brain radiotherapy (WBRT).
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  Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral MLN9708 in Adult Patients With Relapsed and Refractory Multiple Myeloma
  This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD) and disease response of the weekly dosing MLN9708 administered orally in patients with relapsed and refractory multiple myeloma.
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  Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED)
  This is a Phase 3 clinical trial to evaluate the efficacy and safety of the combination of EC145 and pegylated liposomal doxorubicin (PLD; available in the United States as Doxil® and outside the United States as Caelyx®) compared to PLD and placebo.
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  Study of Adding AMG 479 to First Line Chemotherapy in Patients With Optimally Debulked Epithelial Ovarian Cancer
  This study will determine the value of adding AMG 479 (fully human monoclonal antibody against IGF-1R) to paclitaxel and carboplatin first line chemotherapy in patients with optimally debulked (<1 cm) FIGO stage III and IV (positive pleural cytology only) ovarian epithelial (including fallopian tube and primary peritoneal) carcinoma.
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  Study of Blood Samples From Newborns With Down Syndrome
  OBJECTIVES: - To further our biological understanding of the natural history of transient myeloproliferative disorder (TMD) and its relationship to subsequent leukemia by facilitating the development of a TMD cell and protein bank, and repository of DNA/RNA from megakaryoblasts for future biological studies.
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  Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
  The purpose of this study is to evaluate oral doses of BMS-754807 in combination with letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal aromatase inhibitor treatment.
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  Study of Kidney Tumors in Young Patients
  OBJECTIVES: Primary - Classify patients with renal tumors by histological categorization, surgico-pathological stage, presence of metastases, age at diagnosis, tumor weight, and loss of heterozygosity for chromosomes 1p and 16q, to define eligibility for a series of therapeutic studies.
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  Study of Late-Occurring Complications in Childhood Cancer Survivors
  OBJECTIVES: - Identify key late-occurring complications, specifically, cardiac dysfunction (closed to accrual as of 4/17/09), myocardial infarction (closed to accrual as of 6/5/06), ischemic stroke, avascular necrosis (closed to accrual as of 11/26/08), and subsequent malignant neoplasm, in childhood cancer survivors.
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  Study of Oral MLN9708 in Adult Patients With Relapsed or Refractory Light Chain Amyloidosis
  This study will include patients with previously treated systemic relapsed or refractory light-chain (AL) amyloidosis who require further therapy and will be aimed at determining the safety profile and the maximum tolerated dose/recommended phase 2 dose of MLN9708 administered orally.
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  Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
  This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).
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  Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence
  The objective of this study is to determine whether pomalidomide is safe and effective in reversing RBC-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis.
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  Study of Tissue and Blood Samples From Patients With High-Grade Glioma
  OBJECTIVES: - To evaluate the diagnostic and prognostic relevance of various molecular, cytogenetic, and other tumor markers in high-grade glioma in paraffin-embedded tissue collected from patients enrolled in the Mayo Clinic or North Central Cancer Treatment Group (NCCTG) high-grade glioma trials conducted since 1979.
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  Study of Tissue and Blood Samples From Patients With Low-Grade Glioma
  OBJECTIVES: - Evaluate the diagnostic and prognostic relevance of alterations of specific chromosomes and chromosomal regions including 7, 9p, 10p, 10q, 13q, 17p, 17q, 19q, 22q, X, and Y, using PCR analysis of microsatellite repeats and FISH.
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  Study to Evaluate the Diagnostic Value of a Combined Molecular Breast Imaging/ Breast Tomosynthesis Modality
  The purpose of this pilot study is to obtain preliminary data on a new way of imaging the breast that combines the benefits of a 3-D anatomical technique (Digital Tomosynthesis) with those of a functional imaging technique (Molecular Breast Imaging).
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  Sunitinib Malate With or Without Gemcitabine Hydrochloride in Treating Patients With Advanced Kidney Cancer That Cannot Be Removed By Surgery
  OBJECTIVES: Primary - To evaluate the response rate to sunitinib malate with vs without gemcitabine hydrochloride in patients with advanced renal cell carcinoma with sarcomatoid features. Secondary - To evaluate progression-free survival of these patients.
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  Surgery With or Without Internal Radiation Therapy Compared With Stereotactic Body Radiation Therapy in Treating Patients With High-Risk Stage I Non-Small Cell Lung Cancer
  OBJECTIVES: Primary - To ascertain whether patients treated by stereotactic body radiation therapy (SBRT) have a 3-year overall survival (OS) rate that is no more than 10% less than patients treated with sublobar resection (SR).
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  Tadalafil in Preventing Erectile Dysfunction in Patients With Prostate Cancer Treated With Radiation Therapy
  OBJECTIVES: Primary - To determine whether tadalafil maintains spontaneous (off-drug) erectile function, as measured by the International Index of Erectile Function (IIEF) as compared to placebo at weeks 28-30 after initiation of radiotherapy in patients with prostate cancer.
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  Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
  OBJECTIVES: Primary - To determine the effect of endocrine therapy with versus without chemotherapy in patients with node-positive breast cancer who do not have high Recurrence Scores (RS) by Oncotype DX®. Secondary - To compare overall survival (OS), distant disease-free survival (DDFS), and local disease-free interval (LDFI) by receipt of chemotherapy or not and its interaction with RS.
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  Temozolomide and Irinotecan Hydrochloride With or Without Bevacizumab in Treating Young Patients With Recurrent or Refractory Medulloblastoma or CNS Primitive Neuroectodermal Tumors
  OBJECTIVES: Primary - To compare the overall survival (OS) of subjects receiving the combination of temozolomide and irinotecan with that of subjects receiving temozolomide, irinotecan, and bevacizumab for recurrent medulloblastoma (MB)/PNET of childhood.
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  Temozolomide or MEK Inhibitor AZD6244 (Selumetinib) in Treating Patients With Metastatic Melanoma of the Eye
  OBJECTIVES: Primary - To assess the progression-free survival (PFS) in three separate patient populations with metastatic uveal melanoma treated with temozolomide vs MEK inhibitor AZD6244 (selumetinib). Secondary - To assess overall survival (OS). - To assess the overall response rate (RR).
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  Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma
  OBJECTIVES: Primary - To determine the feasibility of administering cixutumumab in combination with an intensive multi-agent interval compressed chemotherapy regimen for the treatment of high-risk metastatic rhabdomyosarcoma (RMS). - To determine the feasibility of adding temozolomide to vincristine and irinotecan in these patients.
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  Temsirolimus and Bevacizumab in Treating Patients With Locally Advanced, Recurrent, Metastatic, or Progressive Endometrial Cancer, Ovarian Epithelial Cancer, Liver Cancer, Islet Cell Cancer, or Carcinoid Tumor
  OBJECTIVES: Primary - To determine the response rate and progression-free survival at 6 months in patients with locally advanced, recurrent, metastatic, or progressive endometrial cancer, ovarian epithelial cancer, hepatocellular carcinoma, islet cell cancer, or carcinoid tumor treated with temsirolimus and bevacizumab.
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  Temsirolimus With or Without Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer Who Did Not Respond to Previous Therapy
  OBJECTIVES: Primary - To determine the progression-free survival (PFS) of patients with recurrent and/or metastatic head and neck cancer who failed prior epidermal growth factor receptor-based (EGFR-based) therapy treated with temsirolimus with vs without cetuximab.
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  Three Different Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide
  OBJECTIVES: Primary - To determine whether administering high-dose thoracic radiotherapy, 70 Gy (2 Gy once daily over 7 weeks) or 61.2 Gy (1.8 Gy once daily for 16 days followed by 1.8 Gy twice daily for 9 days), will improve median and 2-year survival compared with 45 Gy (1.5
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  Two Different Methods of Collecting Stem Cells For an Autologous Stem Cell Transplant in Treating Patients With Diffuse Large Cell Lymphoma
  OBJECTIVES: Primary - Determine the therapeutic effect of instrument-driven lymphocyte enrichment of the autograft absolute lymphocyte count (A-ALC) compared to "standard autograft collection" as determined by progression-free survival post-transplantation. Secondary - Determine the profile of immune effector cells of the "lymphocyte enriched autograft" vs "standard autograft" and peripheral blood after autologous stem cell transplant (ASCT) and their impact on post- ASCT immunological reconstitution and clinical endpoints.
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  Use of Low-dose Molecular Breast Imaging for the Detection of Small Breast Lesions
  A total of 150 patients will be studied. Each patient will have a suspicious lesion on mammogram, ultrasound or breast magnetic resonance imaging (MRI) for which biopsy is scheduled. The lesion size on mammogram, ultrasound or breast MRI must be less than 2 cm in diameter and must be considered "suspicious" or "highly suspicious" for malignancy.
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  Vaccine Therapy With or Without Cryosurgery in Treating Patients With Residual, Relapsed, or Refractory B-Cell Non-Hodgkin Lymphoma
  PRIMARY OBJECTIVES: I. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous DC vaccine injection into a cryoablated tumor site (Arm A). II. Evaluation of safety and tolerability as measured by the incidence of significant toxicity of an autologous mature DC vaccine + tumor lysate generated in vitro and delivered intradermally (ID) (Arm B).
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  Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma
  OBJECTIVES: Primary - Determine the safety and toxicity of Edmonston vaccine strain oncolytic measles virus encoding thyroidal sodium iodide symporter (MV-NIS) when administered with or without cyclophosphamide in patients with relapsed or refractory multiple myeloma.
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  Validation of a Multi-gene Test for Lung Cancer Risk
  Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality.
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  Veliparib With or Without Carboplatin in Treating Patients With Stage III or Stage IV Breast Cancer
  OBJECTIVES: Primary - To determine the efficacy of veliparib with vs without carboplatin in patients with stage III or IV BRCA-associated breast cancer. - To evaluate the progression-free survival of patients treated with these regimens.
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  Vibro-Acoustography Imaging in Diagnosing Breast Masses in Women With a Breast Mass or Breast Cancer
  OBJECTIVES: - To study in vivo detection of breast masses by vibro-acoustography (VA) imaging. - To evaluate the performance of VA imaging in differentiating between benign and malignant breast masses identified as BI-RADS 4 or 5.
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  Vibro-Acoustography Imaging in Finding Breast Microcalcifications and Lesions in Women
  OBJECTIVES: - To further develop a new method of in vivo imaging of the breast using vibro-acoustography (VA) imaging. - To demonstrate and evaluate the capability of VA imaging in detecting microcalcifications and lesions inside the human breast.
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  Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma
  OBJECTIVES: Primary - Determine the failure-free survival of patients with newly diagnosed low-risk rhabdomyosarcoma treated with vincristine, dactinomycin, cyclophosphamide, and radiotherapy. Secondary - Determine local control rates in patients treated with this regimen. - Determine the rate of second-look surgery in patients with bulk residual tumor at diagnosis (clinical group III) and the proportion of second-look surgeries that render patients treated with this regimen tumor-free or with
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  Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor
  OBJECTIVES: Primary - Evaluate the overall and event-free survival of younger patients with newly diagnosed stage I favorable histology Wilms' tumor (< 2 years of age and < 550gms) treated with nephrectomy only (very low risk), or with newly diagnosed stage III favorable histology Wilms tumor with possible nephrectomy followed by vincristine, dactinomycin, doxorubicin hydrochloride, and radiotherapy (standard risk).
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  Vinorelbine Ditartrate and Cyclophosphamide in Combination With Bevacizumab or Temsirolimus in Treating Patients With Recurrent or Refractory Rhabdomyosarcoma
  OBJECTIVES: Primary - To determine the feasibility of administering bevacizumab in combination with intravenous vinorelbine and cyclophosphamide (VC) in patients with recurrent rhabdomyosarcoma (RMS). - To determine the feasibility of administering temsirolimus in combination with VC in patients with recurrent RMS.
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  Viral Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
  OBJECTIVES: Primary - Determine the safety and toxicity of intratumoral and/or resection cavity administration of a recombinant, attenuated Edmonston B vaccine strain derivative of measles virus genetically engineered to produce human carcinoembryonic antigen (CEA) in patients with recurrent glioblastoma multiforme.
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  White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
  OBJECTIVES: I. To compare white wine (Arm A) to non-wine nutritional supplement (Arm B) for the treatment of cancer-associated anorexia. II. To evaluate the side effect profile of white wine (Arm A).
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  Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
  OBJECTIVES: Primary - To determine the maximum-tolerated dose of Z-endoxifen hydrochloride in women with metastatic estrogen-receptor positive (ER+) breast cancer. - To describe the safety profile of Z-endoxifen hydrochloride at each of the doses examined.
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  Z1031, A Phase 3 Trial Comparing 16 to 18 Weeks of Neoadjuvant (Given Before Surgery) Exemestane (25 mg daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women with Stage 2 and 3 Estrogen Receptor Positive Breast Cancer
  Patients are being asked to take part in this study because they have a kind of breast cancer that is affected by the levels of hormones in their body. Patients are also postmenopausal, which can affect the way this kind of cancer responds to certain kinds of treatment.
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  Zoledronic Acid in Treating Patients With Metastatic Breast Cancer, Metastatic Prostate Cancer, or Multiple Myeloma With Bone Involvement
  OBJECTIVES: Primary - To compare the proportion of patients with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma involving bone who experience ≥ 1 skeletal-related event during 2 years of treatment with zoledronic acid administered every 12 weeks vs every 4 weeks.
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