Expired Study
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Bethesda, Maryland 20892


RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, work in different ways to stimulate the immune system and stop tumor cells from growing. Interleukin-2 may stimulate a person's lymphocytes to kill kidney cancer cells. Combining biological therapy with interleukin-2 may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cellular adoptive immunotherapy together with interleukin-2 works in treating patients with metastatic kidney cancer.

Study summary:

OBJECTIVES: Primary - Determine whether adoptive T-lymphocyte transfer combined with interleukin-2 results in clinical tumor regression in patients with metastatic renal cell cancer. OUTLINE: Tumor-reactive T-lymphocytes are isolated from tumor-infiltrating lymphocytes, peripheral blood mononuclear cells, or lymph nodes and expanded in vitro. Several months later, eligible patients receive cultured T-lymphocytes IV over 10-20 minutes followed by interleukin-2 (IL-2) IV over 15 minutes every 8 hours for up to 12 doses. Approximately 1 month later, patients are evaluated. Responding patients continue to receive T-lymphocytes and IL-2 until the cells are used up in the absence of disease progression or unacceptable toxicity. Non-responding patients receive a preparative regimen comprised of cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1. Beginning on day 0, patients receive the cultured T-lymphocytes and IL-2 as before. They also receive filgrastim (GM-CSF) subcutaneously daily until blood counts recover. Treatment may be repeated once approximately 1 month later in the absence of unacceptable toxicity or disease progression AND provided there are an adequate number of cells. PROJECTED ACCRUAL: A total of 29-100 patients (a maximum of 29 to be treated) will be accrued for this study within 3 years.


DISEASE CHARACTERISTICS: - Diagnosis of renal cell carcinoma (RCC) - Metastatic disease - Measurable disease - Tumor progression after treatment with interleukin-2 (only patients receiving cell infusions) - Asymptomatic brain metastases allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - More than 3 months Hematopoietic - Platelet count > 100,000/mm^3 - No coagulation disorders Hepatic - ALT and AST < 3 times upper limit of normal - Total bilirubin ≤ 1.6 mg/dL OR - Direct bilirubin ≤ 0.5 mg/dL - Hepatitis B negative Renal - Creatinine ≤ 1.6 mg/dL Cardiovascular - No major cardiovascular illness - Normal stress cardiac test* NOTE: *For patients with EKG abnormalities, symptoms of cardiac ischemia or arrhythmias, or age > 50 years Pulmonary - No major respiratory illness - FEV_1 > 60 % of predicted* NOTE: *For patients with prolonged history of cigarette smoking or symptoms of respiratory dysfunction Immunologic - No active systemic infections - No major immune system illness - HIV negative - Epstein-Barr virus positive Other - No contraindication to interleukin-2 therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - Not specified Endocrine therapy - No concurrent steroid therapy Radiotherapy - Prior local radiotherapy to non-evaluated sites allowed Surgery - Not specified Other - More than 4 weeks since prior potentially effective therapy for RCC



Primary Contact:

Principal Investigator
James C. Yang, MD
NCI - Surgery Branch

Backup Contact:


Location Contact:

Bethesda, Maryland 20892
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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