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| Sponsor: | Corixa Corporation |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Corixa Corporation |
| ClinicalTrials.gov Identifier: | NCT00022906 |
Purpose
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 |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: Iodine-131 Anti-B1 Antibody |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00022906 History of Changes |
| Other Study ID Numbers: | CP-98-028 |
| Study First Received: | August 15, 2001 |
| Last Updated: | June 23, 2005 |
| 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 |
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Antibodies Immunoglobulins Antibodies, Monoclonal Iodine |
Cadexomer iodine Iodine-131 anti-B1 antibody Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Trace Elements Micronutrients Growth Substances Antineoplastic Agents |