Vaccine Therapy in Treating Patients With Recurrent or Refractory 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. Giving the vaccine with interleukin-2 or sargramostim may help kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of peptide vaccine with or without adjuvant interleukin-2 or sargramostim in treating patients who have recurrent or refractory metastatic melanoma.

Detailed Description
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OBJECTIVES: Determine whether patients with refractory metastatic melanoma undergo partial or complete response to peptides specific to their HLA-antigen, either alone or when combined with 1 of 3 adjuvants. Evaluate the immunologic response to the peptide alone or when combined with 1 of 3 adjuvants in these patients. OUTLINE: Patients are stratified by HLA status (A1 vs A3 vs A24 vs A31). Patients are assigned to 1 of 4 vaccine groups: Group 1 (HLA-A1 positive): Patients receive tyrosinase:240-251. Group 2 (HLA-A3 positive): Patients receive gp100:17-25. (closed to accrual 5/17/2000) Group 3 (HLA-A24 positive): Patients receive tyrosinase:206-214. Group 4 (HLA-A31 positive): Patients receive tyrosinase related protein-1. Each peptide vaccine is separately emulsified in Montanide ISA-51 and administered subcutaneously into the thigh. Patients are treated with peptide vaccine alone or combined with 1 of 3 possible adjuvants (interleukin-2 (IL-2) IV, IL-2 delayed IV, or sargramostim (GM-CSF) SQ) depending on the time of entry into study and response to treatment. At least 4 to 6 patients are accrued for the peptide alone cohort before beginning accrual on the other cohorts. Any patient who experiences unacceptable toxicity due to adjuvant therapy is taken off study. If a second patient develops unacceptable toxicity, that schedule of peptide administration is discontinued. Patients exhibiting stable, minor, mixed, or partial response may receive up to 12 additional courses. Patients are followed for 4-6 weeks. PROJECTED ACCRUAL: A maximum of 457 patients will be accrued for this study over 3.5 years.

Official Title
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Immunization of Patients With Metastatic Melanoma Using Immunodominant Peptides From the Tyrosinase Protein or Tyrosinase Related Protein-1 (TRP1)

Conditions
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Melanoma (Skin)

Intervention / Treatment
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* Biological: aldesleukin
* Biological: incomplete Freund's adjuvant
* Biological: sargramostim
* Biological: tyrosinase peptide
* Biological: tyrosinase-related protein-1


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven refractory metastatic melanoma Must be HLA-A1, HLA-A3, HLA-A24, or HLA-A31 positive Measurable disease PATIENT CHARACTERISTICS: Age: 16 and over Performance Status: ECOG 0-1 Life Expectancy: Greater than 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 90,000/mm^3 No coagulation disorder Hepatic: AST or ALT less than 2 times upper limit of normal Bilirubin no greater than 1.6 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No major cardiovascular disease Pulmonary: No major respiratory disease Other: Not pregnant Fertile patients must use effective contraception HIV negative Hepatitis B surface antigen negative No known allergy to Montanide ISA-51 No active systemic infection No immunodeficiency disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy No concurrent biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No concurrent steroid therapy or other endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: Prior or concurrent surgery for melanoma allowed

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: aldesleukin|nan|
|Biological: incomplete Freund's adjuvant|nan|
|Biological: sargramostim|nan|
|Biological: tyrosinase peptide|nan|
|Biological: tyrosinase-related protein-1|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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recurrent melanoma