Expired Study
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Bethesda, Maryland 20892


RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for metastatic melanoma. PURPOSE: Phase II trial to compare the effectiveness of vaccine therapy with or without interleukin-2 in treating patients who have metastatic melanoma that has not responded to previous therapy.

Study summary:

OBJECTIVES: - Compare the efficacy of gp100:209-217(210M) peptide and MART-1:26-35(27L) peptide administered with or without high-dose interleukin-2 (IL-2) in patients with metastatic melanoma who are HLA-A0201 positive. - Determine the efficacy of these peptides in patients who cannot receive IL-2. - Compare the efficacy of IL-2 with or without these peptides in patients who need immediate treatment with IL-2. - Determine the efficacy of MART-1:26-35(27L) peptide in patients who have received prior gp100 antigen. - Compare the immunologic response experienced by patients who have received peptide, with or without IL-2, as measured by changes in T-cell precursors from before to after treatment. - Compare the toxic effects of these regimens in these patients. OUTLINE: This is a partially randomized study. Patients are assigned to 1 of 4 treatment groups based on disease status and prior therapy. - Group A (eligible to receive interleukin-2 (IL-2) but not in immediate need; no prior immunization with gp100 or MART-1 antigen): Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive gp100 and MART-1 peptides emulsified in Montanide ISA-51 (ISA-51) subcutaneously (SC) on day 1. (Arm I closed as of 10/30/02). - Arm II: Patients receive both peptides as in arm I on day 1 and high-dose IL-2 IV over 15 minutes every 8 hours on days 2-5 (for up to 12 doses). (Arm II closed as of 10/30/02). - Group B (ineligible to receive IL-2 due to other debilitating disease): Patients receive treatment as in group A, arm I. - Group C (need immediate IL-2 therapy due to extensive and rapid progression of disease): Patients receive treatment as in group A, arm II. (Group C closed as of 10/30/02). - Group D (prior immunization with gp100 antigen): Patients receive modified MART-1:26-35(27L) peptide emulsified in ISA-51 SC on day 1. Treatment in all groups repeats every 3 weeks for 4 courses. Patients who achieve a minor, mixed, or partial response may receive up to 12 additional courses. Patients who achieve complete response receive 2 additional courses. Patients are followed at 4-6 weeks. PROJECTED ACCRUAL: A total of 103 patients (15-25 for group A, arm I; 19-33 for group A, arm II; and 15 each for groups B, C, and D) will be accrued for this study within 1 year.


DISEASE CHARACTERISTICS: - Histologically confirmed metastatic melanoma that has failed standard therapy - Measurable disease - HLA-A0201 positive PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - ECOG 0-2 Life expectancy: - More than 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 90,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL (less than 3.0 mg/dL for patients with Gilbert's syndrome) - AST/ALT less than 3 times normal - Hepatitis B surface antigen negative - No coagulation disorder Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No major cardiovascular disease - If cardiovascular disease or other debilitating symptoms present, may receive peptide emulsified with Montanide ISA-51 only Pulmonary: - No major respiratory disease Other: - Not pregnant - Fertile patients must use effective contraception - HIV negative - No active systemic infection - No autoimmune disease or immunodeficiency disease - No primary or secondary immunodeficiency PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic therapy - No prior MART-1 antigen immunization Chemotherapy: - At least 3 weeks since prior chemotherapy Endocrine therapy: - At least 3 weeks since prior endocrine therapy - No concurrent steroid therapy Radiotherapy: - At least 3 weeks since prior radiotherapy Surgery: - Prior surgery allowed



Primary Contact:

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

Backup Contact:


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: October 09, 2019

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