NCT00937300

T-cell Based Immunotherapy for Head and Neck Cancer

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

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Inge Marie Svane · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma
• Head and Neck Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-07-13
• Last updated: 2011-11-23

Locations

1 site across 1 country: Denmark