drugset / Trial / NCT00470015
Vaccine Therapy and GM-CSF With or Without Low-Dose Aldesleukin in Treating Patients With Stage II, Stage III, or Stage IV Melanoma
NaSingle-groupOpen-labelTreatment
Summary
RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Giving vaccine and different doses of GM-CSF mixed in incomplete Freund's adjuvant, with or without aldesleukin, may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and how well giving vaccine therapy together with GM-CSF, with or without low-dose aldesleukin, works in treating patients with stage II, stage III, or stage IV melanoma.
Timeline
- Start
- 2007-03
- Primary completion
- 2009-04
- Completion
- 2013-01-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MART-1 antigen | Vaccine | 1 mg | Subcutaneous |
| Subject | MART-1a peptide | Peptide | 1 mg | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | 0.5 unknown | Subcutaneous |
| Subject | gp100 antigen | Peptide | 1 mg | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | 0.3 mg | Subcutaneous |