Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
Recruitment status was Active, not recruiting
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
PURPOSE: This randomized phase I/II trial is studying three different doses of a vaccine and comparing them to see how well they work in treating patients with stage IIIB, stage IIIC, or stage IV melanoma.
Biological: incomplete Freund's adjuvant
Biological: multi-epitope melanoma peptide vaccine
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Vaccination With Multiple Synthetic Melanoma Peptides Recognized by Helper T-Cells in Patients With Advanced Melanoma|
- Safety if less than 33% of patients experience a dose-limiting toxicity at day 22 [ Designated as safety issue: Yes ]
- Immune response by Proliferation Assay at day 22 [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
- Determine the immune response in patients with stage IIIB, IIIC, or IV melanoma treated with vaccine comprising multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF).
OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive vaccine comprising low-dose multiple synthetic melanoma peptides, Montanide ISA-51, and sargramostim (GM-CSF) on days 1, 8, 15, 29, 36, and 43.
- Arm II: Patients receive vaccine comprising medium-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
- Arm III: Patients receive vaccine comprising high-dose multiple synthetic melanoma peptides, Montanide ISA-51, and GM-CSF as in arm I.
On day 22, the lymph node draining the vaccination site is removed to determine whether the immune system is responding to the vaccine.
PROJECTED ACCRUAL: A maximum of 38 patients will be accrued for this study.
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22908|
|Study Chair:||Craig L. Slingluff, MD||University of Virginia|