vaccine therapy in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: 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.

Eligibility 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

Keywords: stage iv melanoma recurrent melanoma