drugset / Trial / NCT00037037

Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

NCT00037037

RandomizedOpen-labelTreatment

Summary

RATIONALE: Vaccines made from peptides 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 kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Timeline

Start
2001-10
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject MAGE-10.A2 Peptide Intravenous
Subject MART-1 antigen Vaccine Intravenous
Subject NY-ESO-1 peptide vaccine Vaccine
Subject sargramostim Protein / enzyme biologic Subcutaneous
Subject tyrosinase peptide Peptide Intravenous

Indications