T-cell Based Immunotherapy for Head and Neck Cancer
The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.
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 and immune response.
|Squamous Cell Carcinoma Head and Neck Cancer||Biological: cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2||Phase 1|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.|
- toxicity [ Time Frame: week 0 to 20 ]
- immune response [ Time Frame: week 0 to 20 ]
|Study Start Date:||June 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Biological: cyclophosphamide, fludarabine, T-cell infusion, and 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: NCT00937300
|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|