T-cell Based Immunotherapy for Head and Neck Cancer
Phase 1
Withdrawn
- Conditions
- Squamous Cell CarcinomaHead and Neck Cancer
- Registration Number
- NCT00937300
- Lead Sponsor
- Inge Marie Svane
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to 1. Acceptable CBC and blood chemistry results. Acceptable organ functions.
Exclusion Criteria
- Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method toxicity week 0 to 20
- Secondary Outcome Measures
Name Time Method immune response week 0 to 20
Trial Locations
- Locations (1)
Department of Oncology, Copenhagen University Hospital, Herlev
🇩🇰Herlev, Denmark