drugset / Trial / NCT00937300
T-cell Based Immunotherapy for Head and Neck Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2009-06
- Primary completion
- 2011-06
- Completion
- 2011-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 1e+09 cells | Intravenous |
| Subject | Tumor Infiltrating Lymphocytes | Cell therapy | 1e+10 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | aldesleukin | Protein / enzyme biologic | 2e+06 iu | Subcutaneous |