Expired Study
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Bethesda, Maryland 20892


RATIONALE: Vaccines made from a person's white blood cells may make the body build an immune response and kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

Study summary:

OBJECTIVES: - Determine whether reinfused activated cells alone or in conjunction with high or subcutaneous dose interleukin-2 may result in clinical tumor regression in patients with metastatic melanoma who had previously failed therapy on protocols involving immunization against the gp100 molecule. - Determine the survival of infused cells with antitumor activity in these patients. OUTLINE: This is a salvage regimen. Patients undergo leukopheresis to obtain peripheral blood mononuclear cells or tumor biopsy to obtain tumor infiltrating lymphocytes (TIL). Cells are incubated in the presence of gp209-2M peptide and then harvested and cloned. Patients receive 30-minute IV infusions of these in vitro sensitized cells. Treatment repeats every 2 weeks for 2 courses. An additional cohort of 8 patients receives gp209-2M peptide in Montanide ISA-51 subcutaneously in 2 different sites followed 2 days later by the adoptive transfer of cloned lymphocytes. At 4 to 6 weeks after the treatment courses, patients with stable or regressing disease may be retreated. Patients with disease progression after 2 courses may receive 2 additional courses of cell infusion followed by interleukin-2 (IL-2) on one of two schedules. One cohort of patients receives IL-2 by intravenous bolus over 15 minutes every 8 hours beginning on the day after cell infusion and continuing for up to 5 days of each treatment course. Another cohort receives IL-2 by daily subcutaneous injections on days 1-12 of each course of therapy. If after 12-16 patients have been treated with cloned cells alone initially and responses are inadequate, subsequent patients entered into this study are randomized to receive the cell infusion followed by IL-2 on one of the two described schedules. Patients are followed at 4-6 weeks. PROJECTED ACCRUAL: A total of 91 patients will be accrued for this study over 2 years.


DISEASE CHARACTERISTICS: - Histologically proven metastatic melanoma that has failed therapy on protocols involving immunization against the gp100 molecule - Measurable or evaluable metastatic disease - Must be HLA-A201 positive by standard HLA typing PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Greater than 3 months Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 - Hemoglobin greater than 8.0 g/dL Hepatic: - Bilirubin no greater than 2.0 mg/dL - ALT/AST less than 4 times upper limit of normal Renal: - Creatinine no greater than 1.6 mg/dL Cardiovascular: - For patients randomized to receive interleukin-2: - No major medical illnesses of the cardiovascular system Pulmonary: - For patients randomized to receive interleukin-2: - No major medical illnesses of the pulmonary system Other: - HIV negative - Hepatitis B antigen negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - For patients randomized to receive interleukin-2: - No active systemic infection - No other major medical illnesses of immune system - No coagulation disorders PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy Chemotherapy: - At least 4 weeks since prior chemotherapy Endocrine therapy: - No concurrent steroid therapy Radiotherapy: - At least 4 weeks since prior radiotherapy Surgery: - Not specified Other: - No concurrent active treatment of brain metastases



Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
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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