Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma
Summary
RATIONALE: Inserting a laboratory-treated gene into a person's white blood cells may make the body build an immune response to kill tumor cells. Giving cyclophosphamide and fludarabine before a white blood cell infusion may suppress the immune system and allow tumor cells to be killed. Vaccines may make the body build an immune response to kill tumor cells. Aldesleukin may stimulate a person's white blood cells to kill tumor cells. Combining white blood cell infusion with vaccine therapy and aldesleukin may cause a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gene-modified white blood cells when given together with cyclophosphamide, fludarabine, vaccine therapy, and aldesleukin and to see how well it works in treating patients with metastatic melanoma.
Timeline
- Start
- 2004-07
- Primary completion
- 2010-08
- Completion
- 2010-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TCR gene-transduced PBLs | Cell therapy | — | Intravenous |
| Subject | autologous transduced TILs | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | MART-1:27-35 peptide vaccine | Vaccine | — | Subcutaneous |
| Background | aldesleukin | Protein / enzyme biologic | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | Subcutaneous |