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flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer

Stage IV Melanoma Clinical Trial

Official title:
Phase II Study of Flt3 Ligand Alone or in Combination With Melanoma Peptide Immunization in Patients With Metastatic Melanoma or Renal Cell Cancer

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00019396
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Completed
Phase Phase 2
Start date February 1998
Completion date March 2007
View Details
See also
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