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The patients eligible for this trial do not exist anymore due to change in procedures.
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| toxicity | week 0 to 20 |
| Measure | Description | Time Frame |
|---|---|---|
| immune response | week 0 to 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inge Marie Svane, Professor, MD | Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Copenhagen University Hospital, Herlev | Herlev | 2730 | Denmark |
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| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| D007376 | Interleukin-2 |
| C042382 | fludarabine phosphate |
| C082598 | aldesleukin |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| D018307 |
| Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |