Stage IV Melanoma Clinical Trial
Official title:
Melanoma Vaccines: Differentiation Antigen Peptides (MART-1:27-35, Tyrosinase and Gp-100) as Immune Targets
This randomized pilot clinical trial studies vaccine therapy and sargramostim in treating patients with stage IV malignant melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as sargramostim, increase the number of white blood cells and platelets found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for malignant melanoma
PRIMARY OBJECTIVES:
I. Determine the immunological effects of immunization protocols utilizing MART-1:27-35
(MART-1:27-35 peptide vaccine), tyrosinase (tyrosinase peptide) or gp-100 (gp100 antigen)
peptides suspended in incomplete Freund's adjuvant (IFA) in the presence of two different
concentrations of sargramostim (GM-CSF).
II. Define the safety and toxicity profile of an immunization protocol utilizing varying
concentrations of MART-1:27-35, tyrosinase and gp-100 peptides suspended in IFA in the
presence of two different concentrations of GM-CSF.
III. Collect preliminary data on therapeutic efficacy as it relates to parameters of immune
function in patients with stage IV malignant melanoma.
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM I: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen
admixed in incomplete Freund's adjuvant subcutaneously (SC) on day 1 of weeks 0, 3, 6, 9,
12, and 24.
ARM II: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100 antigen
admixed in incomplete Freund's adjuvant SC and lower-dose sargramostim SC on day 1 of weeks
0, 3, 6, 9, 12, and 24.
ARM III: Patients receive tyrosinase peptide, MART-1:27-35 peptide vaccine, and gp100
antigen admixed in incomplete Freund's adjuvant SC and higher-dose sargramostim SC on day 1
of weeks 0, 3, 6, 9, 12, and 24.
In all arms, treatment may repeat every 3 months for up to 18 months in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for up to 3
years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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