T-cell Based Immunotherapy for of Melanoma
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|ClinicalTrials.gov Identifier: NCT00937625|
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : August 18, 2015
The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.
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, tumor response, and immune response.
After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: cyclophosphamide, fludarabine, T-cells, Interleukin-2||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma.|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
- Biological: cyclophosphamide, fludarabine, T-cells, 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. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.Other Names:
- Cyclophosphamide, Sendoxan®, Baxter A/S
- Fludarabine, Fludara®, Bayer Shering
- Interleukin-2, Proleukin®, Chiron B.V.
- toxicity [ Time Frame: week 0 to 20 ]
- immune response [ Time Frame: week 0 to 20 ]
- tumor response [ Time Frame: week 8 and every 3rd week until progression ]
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): NCT00937625
|Department of Oncology, Copenhagen University Hospital, Herlev|
|Herlev, Denmark, 2730|
|Study Director:||Inge Marie Svane, Professor, MD||Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark|
|Principal Investigator:||Rikke Andersen, MD||Center for Cancer Immune Therapy, department of Oncology, Herlev Hospital, Denmark|