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T-cell Based Immunotherapy for Head and Neck Cancer

This study has been withdrawn prior to enrollment.
(The patients eligible for this trial do not exist anymore due to change in procedures.)
Sponsor:
Information provided by (Responsible Party):
Inge Marie Svane, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00937300
First received: July 10, 2009
Last updated: November 22, 2011
Last verified: November 2011
History of Changes

July 10, 2009
November 22, 2011
June 2009
June 2011   (final data collection date for primary outcome measure)
toxicity [ Time Frame: week 0 to 20 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00937300 on ClinicalTrials.gov Archive Site
immune response [ Time Frame: week 0 to 20 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Squamous Cell Carcinoma
  • Head and Neck Cancer
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.
Other Names:
  • Cyclophosphamide, Sendoxan®, Baxter A/S
  • Fludarabine, Fludara®, Bayer Shering
  • Interleukin-2, Proleukin®, Chiron B.V.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00937300
HH0908
Yes
Inge Marie Svane, Herlev Hospital
Inge Marie Svane
Not Provided
Study Director: Inge Marie Svane, Professor, MD Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Herlev Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP