drugset / Trial / NCT00089193

Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma

NCT00089193

RandomizedOpen-labelTreatment

Summary

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.

Timeline

Start
2003-09
Primary completion
2007-02
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject multi-epitope melanoma peptide vaccine Vaccine Subcutaneous
Subject sargramostim Protein / enzyme biologic
Background incomplete Freund's adjuvant Other / unclassified

Indications