Expired Study
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Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00019383


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: December 16, 2017

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