Cancer

Below are current clinical trials.

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1. 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.

2. 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.

3. 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).

4. A Study to Evaluate Ramucirumab Plus Trifluridine/Tipiracil to Treat Patients with Previously-treated Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma

   Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

   The purpose of this study is to compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/Gastroesophageal Junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with TAS-102 vs. paclitaxel and ramucirumab.

    

5. 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.

6. A Study of Hematopoiesis in Patients with Monoclonal B Cell Lymphocytosis (MBL), B-Chronic Lymphocytic Leukemia (CLL), and Healthy Controls

   Rochester, Minn.

   The purpose of this study is to determine the cellular and mechanistic basis of bone marrow hematopoietic dysfunction in untreated Monoclonal B Cell Lymphocytosis (MBL) and B-Chronic Lymphocytic Leukemia (CLL) patients.

7. A Study to Evaluate the Safety and Effectiveness of Lisocatagene Maraleucel in Patients

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to assess the safety of nonconforming lisocabtagene maraleucel in patients, and to assess the effectiveness of nonconforming lisocabtagene maraleucel in patients.

8. 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.

9. Methylation and Chromatin Abnormalities in Myelodysplastic Syndromes and Chronic Myelomonocytic leukemia.

   Rochester, Minn.

   The purpose of this study is to assess tumor cells from blood and bone marrow from patients with myeloid neoplasms for epigenetic dysregulation and abnormalities of chromatin and for immune activation and exhaustion.

10. The Effects of Acute and Chronic Exercise on Immune Phenotype of Indolent Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia Patients

    Rochester, Minn., Scottsdale/Phoenix, Ariz.

    This clinical trial studies the effect of short-term (acute) and long-term (chronic) exercise on immune characteristics and function (phenotype) of patients with indolent non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Most newly-diagnosed CLL patients have early-stage disease at the time of diagnosis and do not require treatment. Despite not needing therapy, these patients have significant immune dysfunction. This may lead to an increased risk of serious infections requiring hospitalization and an increased risk of secondary non-blood-based (hematologic) cancers. Increasing CLL patients overall physical fitness levels, through exercise during the observation stage, may provide a realistic approach means to increase survival, decrease treatment-related side effects, and improve immune function. Information learned from this study may help researchers determine whether a particular exercise regimen can be used to strengthen the immune system of indolent NHL and CLL patients, delay time to disease progression, assess the need for treatment, and assess infection rates.