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NCT00937300 Clinical Trial

T-cell Based Immunotherapy for Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00937300
Other study ID # HH0908
Secondary ID
Status Withdrawn
Phase Phase 1
First received July 10, 2009
Last updated November 22, 2011
Start date June 2009
Est. completion date June 2011

Study information
Verified date November 2011
Source Herlev Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Medicines Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Denmark Department of Oncology, Copenhagen University Hospital, Herlev Herlev

Sponsors (1)
Lead Sponsor Collaborator
Inge Marie Svane

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary toxicity week 0 to 20 Yes
Secondary immune response week 0 to 20 No
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