Trial Information
T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
toxicity
Outcome Time Frame:
week 0 to 20
Safety Issue:
Yes
Principal Investigator
Inge Marie Svane, Professor, MD
Investigator Role:
Study Director
Investigator Affiliation:
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Authority:
Denmark: Danish Medicines Agency
Study ID:
HH0908
NCT ID:
NCT00937300
Start Date:
June 2009
Completion Date:
June 2011
Related Keywords:
- Squamous Cell Carcinoma
- Head and Neck Cancer
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms