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Sponsors and Collaborators: |
Loyola University Wyeth |
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Information provided by: | Loyola University |
ClinicalTrials.gov Identifier: | NCT00838955 |
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.
Condition | Intervention | Phase |
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Hodgkin's Lymphoma |
Drug: Temsirolimus |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Temsirolimus for Relapsed/Refractory Hodgkin's Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | January 2017 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary McCabe, MSN | 708-327-3223 | mmccabe@lumc.edu |
Contact: Mary Lee, BSN | 708-327-2241 | mlee@lumc.edu |
United States, Illinois | |
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center | Recruiting |
Maywood, Illinois, United States, 60153 | |
Contact: Elaine Fluder, MSN 708-216-6198 efluder@lumc.edu | |
Principal Investigator: Danielle Shafer, DO | |
Sub-Investigator: Kevin Barton | |
Sub-Investigator: Laura Michaelis | |
Sub-Investigator: Sucha Nand | |
Sub-Investigator: Tulio Rodriguez | |
Sub-Investigator: Scott Smith | |
Sub-Investigator: Patrick Stiff | |
Sub-Investigator: David Vesole |
Principal Investigator: | Danielle Shafer, DO | Loyola University |
Responsible Party: | Loyola University Cardinal Bernadin Cancer Center ( Danielle Shafer D.O. ) |
Study ID Numbers: | 201170 |
Study First Received: | February 6, 2009 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00838955 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hodgkin's lymphoma relapsed Hodgkin's lymphoma refractory Hodgkin's lymphoma Temsirolimus |
Lymphatic Diseases Immunoproliferative Disorders Hodgkin Lymphoma, Adult Hodgkin's Disease |
Lymphoproliferative Disorders Hodgkin Disease Lymphoma |
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma Hodgkin Disease |