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Sponsors and Collaborators: |
Corixa Corporation GlaxoSmithKline |
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Information provided by: | Corixa Corporation |
ClinicalTrials.gov Identifier: | NCT00022906 |
The purpose of this study is to determine the proper dose, effectiveness, and safety of using Iodine-131 Anti-B1 Antibody for the treatment of patients with previously treated non-Hodgkin's lymphoma (NHL) who have greater than 25% bone marrow involvement with lymphoma.
Condition | Intervention | Phase |
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Non-Hodgkin's Lymphoma |
Drug: Iodine-131 Anti-B1 Antibody |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody For Patients With Previously Treated Non-Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement |
Estimated Enrollment: | 24 |
Study Start Date: | May 1999 |
The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti B-1 Antibody in patients with previously treated NHL having more than 25% bone marrow involvement with lymphoma. Secondary endpoints include assessment of response rate, duration of response, relapse-free survival, time to treatment failure, safety, and survival.
The dose escalation will be started at 45cGy and will be escalated in 10cGy increments until the maximum tolerated dose in reached.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CP-98-028 |
Study First Received: | August 15, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00022906 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Non-Hodgkin's Lymphoma Radioimmunotherapy Monoclonal Antibody Corixa Bexxar |
Anti-B1 Antibody Tositumomab Iodine -131 Anti-B1 Antibody Iodine I 131 Tositumomab |
Immunoproliferative Disorders Immunologic Factors Iodine-131 anti-B1 antibody Trace Elements Lymphoma, Small Cleaved-cell, Diffuse Antibodies, Monoclonal Lymphatic Diseases Anti-Infective Agents, Local |
Antibodies Iodine Micronutrients Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |
Anti-Infective Agents Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Antineoplastic Agents Growth Substances Physiological Effects of Drugs Iodine-131 anti-B1 antibody Trace Elements Pharmacologic Actions Antibodies, Monoclonal |
Anti-Infective Agents, Local Lymphatic Diseases Neoplasms Antibodies Therapeutic Uses Iodine Micronutrients Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Immunoglobulins |