Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


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.

Study summary:

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).


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



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: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.