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Tracking Information | |||||||||
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First Received Date † | February 6, 2009 | ||||||||
Last Updated Date | February 6, 2009 | ||||||||
Start Date † | January 2009 | ||||||||
Current Primary Outcome Measures † |
To estimate the overall response rate (complete or partial response and stable disease by the IWG criteria) to temsirolimus [ Time Frame: 26 weeks ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma | ||||||||
Official Title † | Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma | ||||||||
Brief Summary | This clinical trial is for patients with Hodgkin Lymphoma that has not responded to standard treatment. The purpose of this study is to determine what effects, good or bad, Temsirolimus has on Hodgkin Lymphoma. The study will also determine whether Temsirolimus is tolerated in patients with Hodgkin Lymphoma who have been previously treated with chemotherapy. |
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Detailed Description | Temsirolimus 25 mg IV infusion will be given once weekly on days 1, 8, 15 and 22 of each cycle. Patients will be assessed for response with CT scans after the second cycle, and then after every other cycle until disease progression is confirmed. Patients will be treated with Temsirolimus until disease progression, or up to six cycles. Continuation of therapy beyond cycles is at the discretion of the investigator. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Hodgkin's Lymphoma | ||||||||
Intervention † | Drug: Temsirolimus | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 30 | ||||||||
Estimated Completion Date | January 2017 | ||||||||
Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
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Location Countries † | United States | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00838955 | ||||||||
Responsible Party | Danielle Shafer D.O., Loyola University Cardinal Bernadin Cancer Center | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Loyola University | ||||||||
Collaborators †† | Wyeth | ||||||||
Investigators † |
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Information Provided By | Loyola University | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |