T-cell Based Immunotherapy for of Melanoma
The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.
Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.
After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)
|Melanoma||Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma.|
- toxicity [ Time Frame: week 0 to 20 ]
- immune response [ Time Frame: week 0 to 20 ]
- tumor response [ Time Frame: week 8 and every 3rd week until progression ]
|Study Start Date:||June 2009|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2
- Cyclophosphamide, Sendoxan®, Baxter A/S
- Fludarabine, Fludara®, Bayer Shering
- Interleukin-2, Proleukin®, Chiron B.V.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937625
|Department of Oncology, Copenhagen University Hospital, Herlev|
|Herlev, Denmark, 2730|
|Study Director:||Inge Marie Svane, Professor, MD||Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark|
|Principal Investigator:||Rikke Andersen, MD||Center for Cancer Immune Therapy, department of Oncology, Herlev Hospital, Denmark|