T-cell Based Immunotherapy for Head and Neck Cancer

Sponsor

Inge Marie Svane (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00937300

Collaborator

(none)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Squamous Cell Carcinoma Head and Neck Cancer	Biological: cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

toxicity [week 0 to 20]

Secondary Outcome Measures

immune response [week 0 to 20]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Oncology, Copenhagen University Hospital, Herlev	Herlev		Denmark	2730

Sponsors and Collaborators

Inge Marie Svane

Investigators

Study Director: Inge Marie Svane, Professor, MD, Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark