T-cell Based Immunotherapy for Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00937300|
Recruitment Status : Withdrawn (The patients eligible for this trial do not exist anymore due to change in procedures.)
First Posted : July 13, 2009
Last Update Posted : November 23, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma Head and Neck Cancer||Biological: cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- Biological: cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2
Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks.Other Names:
- Cyclophosphamide, Sendoxan®, Baxter A/S
- Fludarabine, Fludara®, Bayer Shering
- Interleukin-2, Proleukin®, Chiron B.V.
- toxicity [ Time Frame: week 0 to 20 ]
- immune response [ Time Frame: week 0 to 20 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|