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T-cell Based Immunotherapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00937300
Recruitment Status : Withdrawn (The patients eligible for this trial do not exist anymore due to change in procedures.)
First Posted : July 13, 2009
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : June 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :
  1. toxicity [ Time Frame: week 0 to 20 ]

Secondary Outcome Measures :
  1. immune response [ Time Frame: week 0 to 20 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Inge Marie Svane, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT00937300     History of Changes
Other Study ID Numbers: HH0908
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: November 23, 2011
Last Verified: November 2011

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 phosphate
Fludarabine
Interleukin-2
Vidarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents