drugset / Trial / NCT00085462
Gene-Modified White Blood Cells Followed By Interleukin-2 and Vaccine Therapy in Treating Patients With Metastatic Melanoma
Phase 1
Completed
61 enrolled
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI) · collab
Open-labelTreatment
Summary
RATIONALE: Inserting a gene that has been created in the laboratory into a person's white blood cells may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Vaccines may make the body build an immune response to kill tumor cells. Combining gene-modified white blood cell infusions with interleukin-2 and vaccine therapy may kill more tumor cells. PURPOSE: This phase I trial is studying how well giving gene-modified white blood cells when given together with interleukin-2 and vaccine therapy works in treating patients with metastatic melanoma.
Timeline
- Start
- 2004-05
- Primary completion
- 2007-05
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | — | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | — | — |
| Subject | gp100-fowlpox vaccine | Vaccine | — | Intravenous |
| Subject | therapeutic autologous lymphocytes | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |