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
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.
Approximately 54-96 patients (18-32 per treatment group) will be accrued for this study
within 16 months.
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