drugset / Trial / NCT00303836
Vaccine Therapy With or Without Interleukin-2 After Chemotherapy and an Autologous White Blood Cell Infusion in Treating Patients With Metastatic Melanoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This randomized phase II trial is studying how well giving vaccine therapy with or without interleukin-2 after chemotherapy and an autologous white blood cell infusion works in treating patients with metastatic melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy with interleukin-2, chemotherapy, and an autologous white blood cell infusion may be a more effective treatment for metastatic melanoma.
Timeline
- Start
- 2005-11
- Primary completion
- 2007-01
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MART-1 antigen | Vaccine | — | Subcutaneous |
| Subject | aldesleukin | Protein / enzyme biologic | — | Intravenous |
| Subject | gp100 antigen | Peptide | — | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |
| Background | therapeutic autologous lymphocytes | Cell therapy | — | Intravenous |