Expired Study
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Bethesda, Maryland 20892


Purpose:

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).


Criteria:

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


NCT ID:

NCT00020358


Primary Contact:

Study Chair
Steven A. Rosenberg, MD, PhD
NCI - Surgery Branch


Backup Contact:

N/A


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: September 19, 2017

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