Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen
Data Collection
Melanoma+9
+ Neoplasms
+ Neoplasms by Histologic Type
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184V) emulsified in Montanide ISA-51 with or without gp100:209-217 (210M) peptide. Secondary * Compare the toxicity profile of these immunizations in these patients. OUTLINE: This is a randomized study. Patients are assigned to 1 of 2 cohorts according to HLA-A2\*0201 status. Patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms. * Cohort 1 (HLA-A2\*0201-positive patients): Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive immunization comprising recombinant gp100 protein (184V) emulsified in Montanide ISA-51 subcutaneously (SC) on days 1, 22, 43, and 64 (1 course). * Arm II: Patients receive immunization comprising recombinant gp100 protein (184V) and gp100:209-217 (210M) peptide emulsified in Montanide ISA-51 SC on days 1, 22, 43, and 64 (1 course). * Cohort 2 (HLA-A2\*0201-negative patients): Patients receive immunization as in cohort 1, arm I. In both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity. In both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. Patients achieving stable disease or a partial response receive retreatment according to their assigned cohort. Patients with progressive disease who are eligible for interleukin-2 (IL-2) receive retreatment according to their assigned cohort AND high-dose IL-2 IV over 15 minutes 3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). Patients receive up to 3 retreatment courses. Patients achieving a complete response (CR) receive 1 retreatment course beyond CR. Patients with progressive disease who are ineligible for IL-2 administration are removed from the study. PROJECTED ACCRUAL: A total of 45-75 patients (30-50 for cohort 1 \[15-25 per treatment arm\] and 15-25 for cohort 2) will be accrued for this study within 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 16 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Diagnosis of metastatic melanoma * Measurable disease * Progressive disease during or after prior standard treatment with or without interleukin-2 PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 6 months Hematopoietic * WBC at least 3,000/mm\^3 * Platelet count at least 90,000/mm\^3 * Lymphocyte count greater than 500/mm\^3 Hepatic * Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) * ALT and AST less than 3 times normal * Hepatitis B surface antigen negative Renal * Creatinine no greater than 2.0 mg/dL Cardiovascular * No symptomatic cardiac disease Immunologic * No active systemic infection * No autoimmune disease * No known immunodeficiency disease * No known hypersensitivity to study agents * No form of primary or secondary immunodeficiency * No opportunistic infection * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior gp100 peptide vaccine Chemotherapy * More than 6 weeks since prior nitrosoureas Endocrine therapy * No concurrent systemic steroid therapy Radiotherapy * Not specified Surgery * Prior recent (within the past 3 weeks) minor surgical procedures allowed Other * Recovered from prior therapy (toxicity no greater than grade 1) * More than 3 weeks since prior systemic anticancer therapy * No other concurrent systemic anticancer therapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, United StatesOpen Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support in Google MapsNCI - Center for Cancer Research
Bethesda, United States