flt3L With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma or Renal Cell Cancer
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.
|Stage IV Melanoma Stage IV Renal Cell Cancer Recurrent Renal Cell Cancer Recurrent Melanoma||Drug: flt3 ligand Drug: gp100 antigen Drug: MART-1 antigen Drug: Montanide ISA-51 Drug: tyrosinase peptide||Phase 2|
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Start Date:||February 1998|
|Study Completion Date:||March 2007|
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.
Approximately 54-96 patients (18-32 per treatment group) will be accrued for this study within 16 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019396
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Patrick Hwu||National Cancer Institute (NCI)|