Melanoma (Skin)
Conditions
Keywords
stage IV melanoma, recurrent melanoma
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Countries
United States
Outcome results
None listed