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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This study has been withdrawn prior to enrollment.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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • toxicity [ Time Frame: week 0 to 20 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • immune response [ Time Frame: week 0 to 20 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937300

Locations
Denmark
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
  More Information

No publications provided

Responsible Party: Inge Marie Svane, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00937300     History of Changes
Other Study ID Numbers: HH0908
Study First Received: July 10, 2009
Last Updated: November 22, 2011
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cyclophosphamide
Fludarabine monophosphate
Fludarabine
Interleukin-2
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
 Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013