肿瘤科（内科）

以下为当前的临床试验。

按院区、状态和其他条件筛选该研究列表。

1. Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer

   Jacksonville, Fla.

   This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.

2. A Study to Evaluate the da Vinci® Xi™ Surgical System in Nipple Sparing Mastectomy (NSM) Procedures

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to evaluate the safety and effectiveness of the da Vinci Surgical Systems in Nipple Sparing Mastectomy procedures.

3. Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and effective health services, particularly in intensive cancer treatments that require a caregiver, such as CAR-T.

   Our objective in this proposal is to define the long-term needs of CAR-T survivors using patient-reported health-related quality of life (QOL) measures, qualitative interviews, and adverse event data. The rationale for our proposed study is that it will provide the necessary knowledge on CAR-T survivor physical, mental, and social health to formulate a CAR-T specific survivorship program that can be implemented and studied in the future.

   We aim to recruit 100 subjects (50 survivors and 50 caregivers) to the study. Inclusion Criteria are the following:  age ≥ 18, blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma), receiving a CAR-T product, able to complete a written questionnaire in English either independently or with assistance, and able to perform a verbal interview either in person or via phone teleconference. We will survey patients at baseline and then at pre-specified timepoints up to 2 years after CAR-T. Survey questionnaires that have been previously validated in cancer populations will be used to assess: overall quality of life, psychosocial impact, cognitive function, post-traumatic stress, spiritual well-being, and financial toxicity. Patient demographics, adverse events, and comorbidities will also be collected via survey and/or medical record review. A selected subset of participants (10 survivors and 10 caregivers) will be chosen to undergo semi-structured open ended interviewing to obtain a qualitative understanding of unmet needs, social support, and distress. Data will be analyzed and compared to historical lymphoma and transplant cohorts.

4. ALEX Study: A Randomized, Phase III Study Comparing Alectinib with Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase (ALK)-Positive Advanced Non-Small Cell Lung Cancer (NSCLC) Patients

   Scottsdale/Phoenix, Ariz.

   This randomized, active controlled, multicenter Phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with critozinib treatment in patients with treatment-naive ALK-positive advanced NSCLC. Patients will be randomized in a 1:1 ratio to receive either alectinib, 600 mg orally twice daily (BID), or critozinib, 250 mg orally BID. Patients will receive treatment until disease progression, unacceptable toxicity, consent withdrawal or death occurs. The study is expected to last approximately 42 months.

5. A Study of GDC-0199 (ABT-199) Plus MabThera/Rituxan (Rituximab) Compared with Bendamustine Plus MabThera/Rituxan (Rituximab) in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia

   Jacksonville, Fla.

   This open-label, randomized study will compare the efficacy of GDC-0199 plus rituximab (GDC-0199+R) with bendamustine plus MabThera/Rituxan (Rituximab) (B+R) in patients with relapsed or resistant chronic lymphocytic leukemia. Patients will be randomized 1:1 into the two arms. Patients randomized to GDC-0199+R will be given GDC-0199 daily (oral, target dose 400 mg) and will receive 6 cycles of rituximab infused intravenously (IV) on Day 1 of each 28-day cycle (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2).

   Patients randomized to B+R will receive 6 cycles of treatment consisting of a rituximab infusion (Cycle 1: 375 mg/m2; Cycles 2-6: 500 mg/m2) on Day 1 and bendamustine infusions (70 mg/m2) on Days 1 and 2 of each 28-day cycle.

   Patients in the GDC-0199+R arm will continue GDC-0199 treatment until disease progression or 2 years since treatment start, whichever comes first. Anticipated time on study is up to 5 years.

6. A Blood Collection Protocol to Study the Immune Responses of Cancer Patients with Malignancies

   Rochester, Minn., Scottsdale/Phoenix, Ariz.

   This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigator Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

7. Impact of Surgical Removal or Reduction Procedures on Markers of Immune Function in Adult Patients with Renal and Bladder Tumors and Pediatric Patients with Genitourinary Tumors

   Rochester, Minn.

   The purpose of this study is to find out more about certain markers of immune suppression in people with kidney tumors (whether the tumors are benign or cancer). Also want to find out if kidney tumor treatment leads to an improvement in these immune markers.

8. Avelumab In Combination Regimens That Include An Immune Agonist, Epigenetic Modulator, CD20 Antagonist and/or Conventional Chemotherapy in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

   Rochester, Minn.

   Study B9991011 is a multi-center, international, randomized, open label, 2 component (Phase 1b followed by Phase 3), parallel-arm study of avelumab in combination with various agents for the treatment of Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).

9. A Registry for Children Treated with Proton Radiation Therapy

   Rochester, Minn.

   The purpose of the Pediatric Proton Consortium Registry (PPCR) is to enroll children who have been treated with proton radiation in the United States in order to describe the population that currently receives protons and better evaluate its benefits over other therapies. The data collected from this study will help facilitate research on proton beam radiation therapy and allow for collaborative research. The PPCR will collect demographic and clinical data which many centers that deliver proton radiation therapy already collect in routine operations.

10. Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients

    Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to determine the preliminary anti-tumor activity and confirm the safety of VV1 in combination with Cemiplimab. The study will concurrently enroll patients with four distinct advanced malignancies in 5 separate tumor cohorts. The four cancer types are: Non-Small Cell Lung Cancer (NSCLC) and melanoma that are progressing on checkpoint inhibitor (CPI, generally refers to anti-PD(L)1 antibodies) treatment, CPI-naïve hepatocellular carcinoma (HCC), and treatment-naïve endometrioid endometrial cancer.