Clinical trial
Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified…
NCT00091104 · National Institutes of Health Clinical Center (CC), NIH · Completed
Key facts
| NCT number | NCT00091104 |
|---|---|
| Title | Cyclophosphamide and Fludarabine Followed by Vaccine Therapy, Gene-Modified White Blood Cell Infusions, and Aldesleukin in Treating Patients With Metastatic Melanoma |
| Official title | A Study in Metastatic Melanoma Using a Lymphodepleting Conditioning Followed by Infusion of Anti-MART-1 TCR-Gene Engineered Lymphocytes and Subsequent Peptide Immunization |
| Lead sponsor | National Institutes of Health Clinical Center (CC), NIH |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Melanoma (Skin) |
| Intervention type | Biological, Drug, Procedure, Radiation |
| Interventions | MART-1:27-35 peptide vaccine, aldesleukin, filgrastim, incomplete Freund's adjuvant, therapeutic autologous lymphocytes, therapeutic tumor infiltrating lymphocytes, cyclophosphamide, fludarabine phosphate, autologous hematopoietic stem cell transplantation, in vitro-treated peripheral blood stem cell transplantation and 1 more |
| Enrollment | 136 |
| Start date | Jul 1, 2004 |
| Primary completion | Aug 1, 2010 |
| Completion | Oct 1, 2010 |
| First posted | Sep 8, 2004 |
| Last update posted | Mar 15, 2012 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: