T-cell Based Immunotherapy for Head and Neck Cancer

NCT00937300 | Withdrawn Phase 1 DMC

• 1 other identifier: HH0908
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• toxicity

  week 0 to 20

Secondary Outcomes (1)

• immune response

  week 0 to 20

Interventions

cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2 BIOLOGICAL

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.

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inge Marie Svane: lead

Study Sites (1)

Department of Oncology, Copenhagen University Hospital, Herlev

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Cyclophosphamide; fludarabine; Interleukin-2; fludarabine phosphate; aldesleukin

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Inge Marie Svane, Professor, MD

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 13, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: November 23, 2011

Record last verified: 2011-11

Locations

DK (1)