Vaccine Therapy in Treating Patients With Metastatic Melanoma

Phase 2CompletedNCT00019994

National Cancer Institute (NCI)

Overview

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have metastatic melanoma that has not responded to previous therapy.

OBJECTIVES: * Determine the clinical response to immunization using gp100:44-59 antigen peptide plus gp100:209-217 (210M) and MART-1:26-35 (27L) antigen peptides in patients with metastatic melanoma who are HLA-DRB1\*0401 and HLA-A0201 positive. * Determine the clinical response to immunization using gp100:44-59 antigen peptide alone in patients with metastatic melanoma who are HLA-DRB1\*0401 positive but HLA-A0201 negative. * Determine the immunologic response in patients treated with these regimens as measured by changes in T-cell precursors from before to after treatment. * Evaluate the toxicity profiles of these regimens in these patients. OUTLINE: Patients are assigned to one of three immunization groups based on HLA-A0201 status and prior gp100:209-217 (210M) antigen peptide immunization: * Group 1 (HLA-A0201 positive and no prior gp100:209-217 \[210M\] antigen peptide): Patients receive gp100:44-59 and gp100:209-217 (210M) antigen peptides emulsified together in Montanide ISA-51 (ISA-51) subcutaneously (SC) and gp100:44-59 and MART-1:26-35 (27L) antigen peptides emulsified together in ISA-51 SC. * Group 2 (HLA-A0201 positive and prior gp100:209-217 \[210M\] antigen peptide): Patients receive treatment as in group 1. * Group 3 (HLA-A0201 negative and no prior gp100:209-217 \[210M\] antigen peptide): Patients receive gp100:44-59 antigen peptide emulsified in ISA-51 SC alone. * All groups: Treatment repeats every 3 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients with complete response after 4 doses receive a maximum of 2 additional doses. Patients with stable disease or minor, mixed, or partial response after 4 doses receive a maximum of 12 additional doses. Patients with no response after 4 doses receive immunization with the same peptides and interleukin-2 IV over 15 minutes every 8 hours for a maximum of 12 doses beginning 1 day after each immunization. Patients are followed at 3-4 weeks. PROJECTED ACCRUAL: A total of 45-75 patients (15-25 per immunization group) will be accrued for this study within 2 years.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Conditions

Melanoma (Skin)

Interventions

MART-1 antigenBIOLOGICAL

aldesleukinBIOLOGICAL

gp100 antigenBIOLOGICAL

incomplete Freund's adjuvantBIOLOGICAL

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven metastatic melanoma that has failed standard treatment * HLA-DRB1\*0401 positive * Known HLA-A0201 status 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 * AST or ALT 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 autoimmune disease * No primary or secondary immunodeficiency disease * HIV negative Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active systemic infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunization to the entire gp100 molecule * At least 3 weeks since prior gp100:209-217 antigen peptide * At least 3 weeks since other prior biologic therapy 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 for cancer allowed Other: * At least 3 weeks since any prior therapy except surgery for cancer

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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