NCT00937300
Withdrawn
Phase 1
T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
Inge Marie Svane1 site in 1 countryJune 2009
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma
- Sponsor
- Inge Marie Svane
- Locations
- 1
- Primary Endpoint
- toxicity
- Status
- Withdrawn
- Last Updated
- 14 years ago
Overview
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.
Investigators
Inge Marie Svane
Professor
Herlev Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to
- •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.
Outcomes
Primary Outcomes
toxicity
Time Frame: week 0 to 20
Secondary Outcomes
- immune response(week 0 to 20)
Study Sites (1)
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