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T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.


Phase 1
18 Years
70 Years
Not Enrolling
Both
Squamous Cell Carcinoma, Head and Neck Cancer

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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

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