drugset / Trial / NCT00089063
Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
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 who have undergone surgery for stage IIB, stage IIC, stage III, or stage IV melanoma. Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may make a stronger immune response.
Timeline
- Start
- 2004-06
- Primary completion
- 2007-06
- Completion
- 2007-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MART-1 antigen | Vaccine | — | Subcutaneous |
| Subject | gp100 antigen | Peptide | — | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | — | Subcutaneous |
| Subject | tyrosinase peptide | Peptide | — | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |