flt3l with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer

Conditions: Stage IV Melanoma; Stage IV Renal Cell Cancer; Recurrent Renal Cell Cancer; Recurrent Melanoma

Summary: rationale: the drug flt3l may stimulate a person's immune system and help to kill tumor cells. vaccines made from melanoma cells may make the body build an immune response to and kill their tumor cells. purpose: phase ii trial to study the effectiveness of flt3l with or without vaccine therapy in treating patients with metastatic melanoma or renal cell cancer.

objectives: i. evaluate the immunologic and biologic activity of flt3 ligand (flt3l) alone in patients with metastatic renal cell cancer or hla-a2.1 negative melanoma. ii. evaluate the immunologic and biologic activity of flt3l alone or in combination with melanoma peptide immunization (mart-1, gp100:209-217, gp100:280-288, and tyrosinase) in patients with metastatic, hla-a2.1 positive melanoma. protocol outline: patients are assigned to 1 of 3 treatment groups: group 1 (renal cell cancer): patients receive flt3 ligand (flt3l) subcutaneously (sq) alone on days 1-14. group 2 (hla-a2.1 negative melanoma): patients receive flt3l sq alone on days 1-14. group 3 (hla-a2.1 positive melanoma): patients may receive either flt3l sq alone on days 1-14 or in combination with melanoma peptide immunization. patients may receive melanoma peptide immunization comprised of mart-1 immunodominant peptide, gp100:209-217, gp100:280-288, and tyrosinase peptide emulsified in montanide isa-51 sq on day 12 of flt3l administration. treatment repeats every 4 weeks for 2 courses. patients with no response or minor response may receive 2 additional courses. patients with disease progression after 1 course are removed from study. projected accrual: approximately 54-96 patients (18-32 per treatment group) will be accrued for this study within 16 months.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- histologically proven metastatic melanoma or renal cell cancer patients receiving melanoma peptide immunizations must be hla-a2.1 positive measurable disease --prior/concurrent therapy-- biologic therapy: at least 1 month since prior biologic therapy chemotherapy: at least 1 month since prior chemotherapy endocrine therapy: no concurrent systemic steroid therapy at least 1 month since prior steroid therapy radiotherapy: at least 1 month since prior radiotherapy surgery: prior surgery allowed other: greater than 1 month since prior therapy --patient characteristics-- age: not specified performance status: ecog 0-1 life expectancy: greater than 3 months hematopoietic: wbc at least 3,000/mm3 platelet count at least 90,000/mm3 no coagulation disorders hepatic: bilirubin no greater than 1.6 mg/dl ast and alt less than 2 times normal renal: creatinine no greater than 2 mg/dl cardiovascular: no major cardiovascular disease pulmonary: no major pulmonary disease other: not pregnant or nursing negative pregnancy test hiv negative hepatitis b surface antigen negative no allergic reaction to montanide isa-51 no active systemic infection no prior autoimmune disorders

Keywords: adult solid tumor body system/site cancer cancer kidney tumor kidney/urinary cancer melanoma recurrent melanoma recurrent renal cell cancer renal cell cancer skin tumor solid tumor stage iv melanoma stage iv renal cell cancer stage, melanoma stage, renal cell cancer