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T-cell Based Immunotherapy for Head and Neck Cancer

NCT ID: NCT00937300

Last Updated: 2011-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Squamous Cell Carcinoma Head and Neck Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Cyclophosphamide, Sendoxan®, Baxter A/S Fludarabine, Fludara®, Bayer Shering Interleukin-2, Proleukin®, Chiron B.V.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inge Marie Svane

OTHER

Sponsor Role lead

Responsible Party

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Inge Marie Svane

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Inge Marie Svane, Professor, MD

Role: STUDY_DIRECTOR

Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark

Locations

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Department of Oncology, Copenhagen University Hospital, Herlev

Herlev, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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HH0908

Identifier Type: -

Identifier Source: org_study_id