Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and sargramostim to see how well they work compared to vaccine therapy alone in treating patients with stage II B, stage IIC, stage III, or stage IV melanoma.
|Melanoma (Skin)||Biological: incomplete Freund's adjuvant Biological: multi-epitope melanoma peptide vaccine Biological: sargramostim||Phase 2|
|Study Design:||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Evaluation of GM-CSF-in-Adjuvant and the Number of Vaccine Sites on Immunization With Multiple Synthetic Melanoma Peptides|
|Study Start Date:||September 2003|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
- Compare immune response in patients with stage IIB-IV melanoma treated with vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 with vs without sargramostim (GM-CSF).
- Compare immune response in patients treated with these vaccinations administered at 1 vs 2 sites.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 1 injection site.
- Arm II: Patients receive vaccination comprising multiple synthetic melanoma peptides and Montanide ISA-51 at 2 injection sites.
- Arm III: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) at 1 injection site.
- Arm IV: Patients receive vaccination comprising multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF at 2 injection sites.
In all arms, treatment repeats once weekly for 6 weeks. Patients return for booster vaccinations at weeks 12, 26, 39, and 52.
PROJECTED ACCRUAL: A maximum of 124 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089193
|United States, District of Columbia|
|Washington Cancer Institute at Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111-2497|
|Hillman Cancer Center at University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15232|
|United States, Texas|
|MD Anderson Cancer Center at University of Texas|
|Houston, Texas, United States, 77030-4009|
|United States, Virginia|
|Cancer Center at the University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Craig L. Slingluff, MD||University of Virginia|