Melanoma (Skin)
Conditions
Keywords
recurrent melanoma
Brief summary
RATIONALE: Vaccines made from white blood cells treated with antigens may make the body build an immune response to kill melanoma cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may kill more melanoma cells. PURPOSE: This phase I/II trial is studying the side effects and how well giving vaccine therapy and interleukin-2 works compared to vaccine therapy alone in treating patients with metastatic melanoma that has not responded to previous therapy.
Detailed description
OBJECTIVES: * Evaluate the toxicity, immunologic reactivity, and possible therapeutic efficacy of immunization with dendritic cells presenting the MART-1 and gp100 melanoma antigens with or without interleukin-2 in patients with metastatic melanoma. OUTLINE: This is a dose-escalation study of dendritic cells pulsed with MART-1 and gp100 antigens. Patients receive vaccinations with dendritic cells pulsed with MART-1 and gp100 antigens, either intralymphatically every 4 weeks for 2 doses, or IV every 3 weeks for 4 doses. Some patients also receive interleukin-2 subcutaneously or IV, over 3-5 days, beginning 24 hours after immunization. Cohorts of 2-9 patients receive escalating doses of pulsed dendritic cells IV until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Subsequent cohorts receive cells with or without interleukin-2. One cohort may expand to 15 patients to determine the accuracy of immunologic response to the vaccine. One cohort of 11 patients receives cells intralymphatically without interleukin-2 every 3-4 weeks for 2 courses. Patients with stable disease or who achieve minor, mixed, or partial response may be retreated. Patients with stable or responding disease undergo a second course of vaccination. Patients who completed treatment with vaccine alone and have stable disease, progressive disease, disease progression after a response, or a partial response with no further improvement may receive 2 additional courses. PROJECTED ACCRUAL: A total of 10-42 patients will be accrued for this study.
Interventions
BIOLOGICALMART-1 antigen
BIOLOGICALaldesleukin
BIOLOGICALgp100 antigen
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 confirmed metastatic melanoma that has failed standard effective therapy * Measurable or evaluable disease * HLA-A2 positive PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/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 * AST/ALT less than 4 times upper limit of normal * Negative hepatitis B surface antigen * No coagulation disorder Renal: * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance greater than 75 mL/min Cardiovascular: * No major cardiovascular disease Pulmonary: * No major respiratory disease Other: * No major immunological disease * No penicillin allergy * HIV negative * No active systemic infection * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * At least 4 weeks since prior steroid therapy and recovered Radiotherapy * Not specified Surgery * Not specified Other * More than 4 weeks since any other prior therapy and recovered
Countries
United States
Outcome results
None listed