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
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Tracking Information | |||||||
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First Submitted Date ICMJE | July 10, 2009 | ||||||
First Posted Date ICMJE | July 13, 2009 | ||||||
Last Update Posted Date | August 18, 2015 | ||||||
Study Start Date ICMJE | June 2009 | ||||||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
toxicity [ Time Frame: week 0 to 20 ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | T-cell Based Immunotherapy for of Melanoma | ||||||
Official Title ICMJE | T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma. | ||||||
Brief Summary | 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) |
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Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Melanoma | ||||||
Intervention ICMJE | 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:
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Study Arms ICMJE | Not Provided | ||||||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
31 | ||||||
Original Estimated Enrollment ICMJE |
6 | ||||||
Actual Study Completion Date ICMJE | January 2015 | ||||||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Denmark | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00937625 | ||||||
Other Study ID Numbers ICMJE | MM0909 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | Inge Marie Svane, Herlev Hospital | ||||||
Study Sponsor ICMJE | Inge Marie Svane | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Herlev Hospital | ||||||
Verification Date | August 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |