Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients
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ClinicalTrials.gov Identifier: NCT00287131 |
Recruitment Status
: Unknown
Verified March 2012 by Sheba Medical Center.
Recruitment status was: Recruiting
First Posted
: February 6, 2006
Last Update Posted
: March 29, 2012
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Tracking Information | ||||
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First Submitted Date ICMJE | February 2, 2006 | |||
First Posted Date ICMJE | February 6, 2006 | |||
Last Update Posted Date | March 29, 2012 | |||
Study Start Date ICMJE | January 2006 | |||
Estimated Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Response rate and toxicity [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE |
Response rate and toxicity | |||
Change History | Complete list of historical versions of study NCT00287131 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients | |||
Official Title ICMJE | Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients | |||
Brief Summary | Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma. Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Melanoma | |||
Intervention ICMJE | Procedure: Procedure - Adoptive cell transfer
Procedure - Adoptive cell transfer |
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Study Arms | 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 | Unknown status | |||
Estimated Enrollment ICMJE |
70 | |||
Original Enrollment ICMJE |
20 | |||
Estimated Study Completion Date | November 2013 | |||
Estimated Primary Completion Date | December 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00287131 | |||
Other Study ID Numbers ICMJE | SHEBA-04-3518-JS-CTIL | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sheba Medical Center | |||
Study Sponsor ICMJE | Sheba Medical Center | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Sheba Medical Center | |||
Verification Date | March 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |