Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma
Completed · Phase 1
Conditions studied: Melanoma (Skin)
In brief
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.
Key facts
- Study ID
- NCT00091104
- Run by
- National Institutes of Health Clinical Center (CC)
- People needed
- 136
- Starts
- 2004-07-01
- Expected to finish
- 2010-10-01
- Last updated by the study team
- 2012-03-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office — Bethesda, Maryland, United States
- NCI - Surgery Branch — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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