Vaccine Therapy in Treating Patients With Metastatic Melanoma

National Cancer Institute (NCI)

Status and phase: Completed; Phase 2

Conditions: Melanoma (Skin)

Treatments: Biological: aldesleukin; Biological: incomplete Freund's adjuvant; Biological: MART-1 antigen; Biological: gp100 antigen

Study type: Interventional

Funder types: NIH

Identifiers

NCT00019994

CDR0000067391

NCI-99-C-0159

NCI-T99-0079

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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