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Sponsors and Collaborators: |
Stanford University GlaxoSmithKline |
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Information provided by: | Stanford University |
ClinicalTrials.gov Identifier: | NCT00490490 |
We hope to learn whether I-131 tositumomab combined with external beam radiation therapy is an effective means of treating relapsed, bulky non-Hodgkin's lymphoma. The purpose of the study is to determine the overall response rate with responses described as: Site-dependent and overall CR and functional CR (CR of CRu/PR with PET negativity), or PR rates.
Condition | Intervention | Phase |
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Lymphoma, Non-Hodgkin |
Drug: Tositumomab and iodine I 131 tositumomab Procedure: External beam radiotherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study of Bexxar Combined With External Beam Radiation Therapy for Patients With Relapsed, Bulky Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 25 |
Study Start Date: | January 2007 |
At the present time over 1,600 patients have been treated with iodine I 131 tositumomab (Bexxar) in a variety of clinical trials. The overall clinical data demonstrate that patients with relapsed or refractory low-grade or transformed low-grade, CD20-positive, B-cell non-Hodgkin's lymphoma derive significant therapeutic benefit from iodine I 131 tositumomab. Data describing its safety and efficacy are available for over 700 patients. In aggregate, the data demonstrate that iodine I 131 tositumomab produces: 1) high overall and complete response rates, 2) clinically meaningful prolongations of response compared to those achieved after patients last prior therapies, 3) durable complete responses, and 4) manageable toxicity in patients with low grade or transformed non-Hodgkin's lymphoma. The purpose of this study is to study the safety and efficacy of this treatment in combination with external beam radiation in patients with relapsed bulky NHL.
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:- Histologically confirmed low grade CD20+ B cell NHL patients who have relapsed after chemotherapy or are chemotherapy resistant and have one or more sites of disease measuring more than 5 cm.
Acceptable laboratory status within 2 weeks prior to patient enrollment including:
Patients with impaired bone marrow reserve as indicated by one or more of the following:
United States, California | |
Stanford University School of Medicine | Recruiting |
Stanford, California, United States, 94305 | |
Contact: Dana Peralta 650-725-1730 pdawn07@stanford.edu | |
Contact: Cancer Clinical Trials Office (650) 498-7061 | |
Principal Investigator: Susan J Knox | |
Sub-Investigator: Ranjana Hira Advani | |
Sub-Investigator: Kristen N. Ganjoo | |
Sub-Investigator: Michael L Goris | |
Sub-Investigator: Richard T. Hoppe | |
Sub-Investigator: Ronald Levy |
Principal Investigator: | Susan J Knox | Stanford University |
Study ID Numbers: | LYMNHL0046, 97437, NCT00490490 |
Study First Received: | June 20, 2007 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00490490 History of Changes |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
Antibodies, Monoclonal Lymphoma, Small Cleaved-cell, Diffuse Lymphatic Diseases Antibodies Immunoproliferative Disorders Immunologic Factors |
Iodine-131 anti-B1 antibody Iodine Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Physiological Effects of Drugs Iodine-131 anti-B1 antibody Pharmacologic Actions |
Antibodies, Monoclonal Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |