Vaccine Therapy in Treating Patients With Melanoma

Phase 2CompletedNCT00020358

National Cancer Institute (NCI)

Overview

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Vaccine therapy may be an effective treatment for melanoma. PURPOSE: Randomized phase II trial to study the effectiveness of three vaccine therapy regimens in treating patients who have melanoma.

OBJECTIVES: * Compare the immunologic activity of three different schedules of peptide immunization with gp100:209-217 (210M) or gp100:17-25 antigen and tyrosinase:368-376 (370D), tyrosinase:240-251 (244S), tyrosinase:206-214 (closed to accrual 11/05/01), or tyrosinase-related protein-1 (ORF3):1-9 peptide (closed to accrual 11/05/01) emulsified in Montanide ISA-51 in patients with melanoma at high risk for recurrence. * Compare the response rate to treatment with interleukin-2 (IL-2) after being immunized with this regimen with the usual response rate to IL-2 in this patient population. * Determine whether an exploratory cohort of HLA-A2-positive patients demonstrate immunologic activity to immunization with 2 peptides emulsified together. OUTLINE: This is a randomized study. Patients are stratified according to HLA type (A0201 vs A1 vs A3 vs A24 vs A31). (HLA-A24 and HLA-A31 closed to accrual 11/05/01). Patients are randomized to 1 of 3 treatment arms and are given an assigned vaccine, which is emulsified in Montanide ISA-51. * HLA typing: * HLA-A2: gp100:209-217 (210M) and tyrosinase:368-376 (370D) * HLA-A1: tyrosinase:240-251 (244S) * HLA-A3: gp100:17-25 * HLA-A24: tyrosinase:206-214 (closed to accrual 11/05/01) * HLA-A31: tyrosinase-related protein-1 (ORF3):1-9 (closed to accrual 11/05/01) * Arm I: Patients receive assigned vaccine subcutaneously (SC) weekly for 10 weeks followed by 3 weeks of no treatment. * Arm II: Patients receive assigned vaccine SC on days 1, 22, 43, and 64. * Arm III: Patients receive assigned vaccine SC on days 1-4, 22-25, 43-46, and 64-67. Treatment in all arms repeats every 13 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. After the completion of the randomized arms of HLA-A2 patients, additional HLA-A2 patients receive immunization with gp100:209-217 (210M) and tyrosinase:368-376 (370D) emulsified in Montanide ISA-51 SC once every 3 weeks for 4 courses. Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours for up to 4 days. Treatment repeats every 10-14 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients with stable disease or mixed or partial response to treatment may receive additional courses every 2 months. Patients are followed at 6 months. PROJECTED ACCRUAL: A total of 324 patients (19-33 per arm for the HLA-A0201 stratum, 13-16 per arm for the other 4 strata, and 33 per the additional HLA-A2 cohort) will be accrued for this study within 2 years. (HLA-A24 and HLA-A31 closed to accrual 11/05/01).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Melanoma (Skin)

Interventions

aldesleukinBIOLOGICAL

gp100 antigenBIOLOGICAL

incomplete Freund's adjuvantBIOLOGICAL

tyrosinase peptideBIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of melanoma, including one of the following characteristics: * Lesions at least 1.5 mm in thickness * At least 1 positive lymph node * Ulcerated lesion * Local recurrence * Metastatic lesions completely resected within the past 6 months * Clinically disease free within the past 6 weeks * HLA-A1, A3, A24, A31, or 0201 positive (HLA-A24 and HLA-A31 closed to accrual 11/05/01) * No ocular or mucosal melanoma PATIENT CHARACTERISTICS: Age: * 16 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 Hepatic: * Bilirubin no greater than 1.6 mg/dL (3.0 mg/dL in Gilbert's syndrome) * AST and ALT less than 3 times normal * Hepatitis B surface antigen negative Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * For interleukin-2 (IL-2) therapy: * No cardiac ischemia, myocardial infarction, or cardiac arrhythmias * Stress cardiac test required if abnormal EKG, symptoms of cardiac ischemia or arrhythmia, or older than 50 years Pulmonary: * For IL-2 therapy: * No obstructive or restrictive pulmonary disease * FEV\_1 greater than 60% predicted if prolonged history of cigarette smoking or symptoms of respiratory dysfunction Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No active systemic infections, autoimmune disease, or active primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 3 weeks since prior systemic biologic therapy for melanoma * No prior gp100 antigen or tyrosinase or TRP-1 peptide * No other concurrent systemic biologic therapy for melanoma Chemotherapy: * At least 3 weeks since prior systemic chemotherapy and recovered * No concurrent systemic chemotherapy for melanoma Endocrine therapy: * At least 3 weeks since prior systemic endocrine therapy for melanoma * No concurrent systemic steroid therapy Radiotherapy: * At least 3 weeks since prior systemic radiotherapy and recovered * No concurrent systemic radiotherapy for melanoma Surgery: * See Disease Characteristics

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.