Back to resultsT-cell Based Immunotherapy for Head and Neck Cancer
Primary Purpose
Squamous Cell Carcinoma, Head and Neck Cancer
Status
Withdrawn
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma
Eligibility 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.
Sites / Locations
- Department of Oncology, Copenhagen University Hospital, Herlev
Outcomes
Primary Outcome Measures
toxicity
Secondary Outcome Measures
immune response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00937300
Brief Title
T-cell Based Immunotherapy for Head and Neck Cancer
Official Title
T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Withdrawn
Why Stopped
The patients eligible for this trial do not exist anymore due to change in procedures.
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inge Marie Svane
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma, Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2
Other Intervention Name(s)
Cyclophosphamide, Sendoxan®, Baxter A/S, Fludarabine, Fludara®, Bayer Shering, Interleukin-2, Proleukin®, Chiron B.V.
Intervention Description
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.
Primary Outcome Measure Information:
Title
toxicity
Time Frame
week 0 to 20
Secondary Outcome Measure Information:
Title
immune response
Time Frame
week 0 to 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Marie Svane, Professor, MD
Organizational Affiliation
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Department of Oncology, Copenhagen University Hospital, Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
T-cell Based Immunotherapy for Head and Neck Cancer
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