Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

Study Overview
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Brief Summary
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RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: This randomized phase II trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.

Detailed Description
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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.

Official Title
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Immunization Of Patients With Metastatic Melanoma Using A Recombinant GP100 Protein (184V) And A Class I Restricted Peptide From The GP100 Antigen

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: aldesleukin
* Biological: gp100 antigen
* Biological: incomplete Freund's adjuvant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: gp100 antigen|nan|
|Biological: incomplete Freund's adjuvant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV melanoma, recurrent melanoma