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Sponsors and Collaborators: |
Rush University Medical Center GlaxoSmithKline Millennium Pharmaceuticals, Inc. |
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Information provided by: | Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT00479167 |
The purpose of this study is to determine what dose of bortezomib in combination with tositumomab I-131 is tolerable whether bortezomib and Tositumomab I-131 are effective in the treatment of relapsed or refractory non-hodgkin's lymphoma (NHL). Both agents are effective in treating relapsed and refractory NHL. Administer of the agents together may sensitize the cells to the radiation from Tositumomab I-131.
Condition | Intervention | Phase |
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Follicular Lymphoma |
Drug: Bortezomib and Tositumomab I-131 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Trial of Combined Weekly Bortezomib and Tositumomab I-131 in Patients With Relapsed or Refractory Follicular Non-Hodg |
Estimated Enrollment: | 20 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Stephanie A Gregory, MD | (312)942-5982 | Stephanie_A_Gregory@rush.edu |
Contact: Teresa M O'Brien, RN | (312)942-5689 | teresa_obrien@rush.edu |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Teresa M O'Brien, RN 312-942-5689 teresa_obrien@rush.edu | |
Principal Investigator: Stephanie A Gregory, MD | |
Sub-Investigator: Parameswaran Venugopal, MD | |
Sub-Investigator: Henry Fung, MD | |
Sub-Investigator: Jamile Shammo, MD | |
Sub-Investigator: Melissa Larson, MD |
Principal Investigator: | Stephanie A Gregory, MD | Rush University Medical Center |
Responsible Party: | Rush University Medical Center ( Dr. Stephanie Gregory ) |
Study ID Numbers: | LYM 2005-01 |
Study First Received: | May 24, 2007 |
Last Updated: | December 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00479167 |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's Lymphoma Follicular Non-Hodgkin's Lymphoma Lymphoma |
Immunoproliferative Disorders Bortezomib Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Iodine-131 anti-B1 antibody Antibodies, Monoclonal Lymphatic Diseases |
Antibodies Iodine Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |