Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in 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.
Primary Purpose: Treatment
National Cancer Institute (NCI)
United States: Federal Government
|Surgery Branch||Bethesda, Maryland 20892|