drugset / Trial / NCT00031733
Vaccine Therapy and Interleukin-12 With Either Alum or Sargramostim After Surgery in Treating Patients With Melanoma
Phase 2
Completed
60 enrolled
University of Southern California
National Cancer Institute (NCI) · collab
RandomizedTreatment
Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response. Combining vaccine therapy with interleukin-12 and either alum or sargramostim may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of combining vaccine therapy with interleukin-12 and either alum or sargramostim in treating patients who have undergone surgery for stage II, stage III, or stage IV melanoma.
Timeline
- Start
- 2002-02
- Primary completion
- 2004-12
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MART-1 antigen | Vaccine | — | — |
| Subject | alum adjuvant | Unknown | — | Subcutaneous |
| Subject | gp100 antigen | Peptide | — | — |
| Subject | recombinant interleukin-12 | Protein / enzyme biologic | — | Subcutaneous |
| Subject | sargramostim | Protein / enzyme biologic | — | Subcutaneous |
| Subject | tyrosinase peptide | Peptide | — | — |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | — |