drugset / Trial / NCT00062036
Cyclophosphamide and Fludarabine Followed By Interleukin-2 Gene-Modified Tumor Infiltrating Lymphocytes in Treating Patients With Metastatic Melanoma
Phase 1/2
Completed
33 enrolled
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI) · collab
Open-labelTreatment
Summary
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide and fludarabine use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the gene for interleukin-2 into a person's tumor infiltrating lymphocytes may make the body build an immune response to kill tumor cells. Combining cyclophosphamide and fludarabine with gene-modified tumor cells may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of gene-modified tumor infiltrating lymphocytes when given together with cyclophosphamide and fludarabine and to see how well they work in patients with metastatic melanoma (phase I is closed to accrual 3/29/06).
Timeline
- Start
- 2003-06
- Primary completion
- 2007-02
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | aldesleukin | Protein / enzyme biologic | — | Intravenous |
| Subject | interleukin-2 gene | Unknown | — | — |
| Subject | therapeutic tumor infiltrating lymphocytes | Cell therapy | — | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | Subcutaneous |
| Background | incomplete Freund's adjuvant | Other / unclassified | — | — |