Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Biological: gp100 antigen; Biological: incomplete Freund's adjuvant; Biological: aldesleukin

Study type: Interventional

Funder types: NIH

Identifiers

NCT00072085

CDR0000335441

NCI-6210

NCI-03-C-0299

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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