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| Sponsor: | Corixa Corporation |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | Corixa Corporation |
| ClinicalTrials.gov Identifier: | NCT00022880 |
Purpose
The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1 Antibody that can be given without causing severe side effects.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Lymphocytic Leukemia |
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: | A Phase I, Dose-Escalation, Open-Label, Multicenter Study of Iodine-131, Anti-B1 Antibody for Intermediate- and High-Risk B-Cell Chronic Lymphocytic Leukemia |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 1999 |
The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti-B1 Antibody in patients with CLL. 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 35cGy for patients with platelet counts > 100,000 cells/mm3 (Cohort A) and increased by groups in 10cGy increments until the maximum tolerated dose (MTD) is reached. Subsequently, patients with platelet counts from 75,000-100,000 cells/mm3 (Cohort B) will be enrolled starting at 10cGy below the MTD reached in Cohort A and the dose will be escalated in 10cGy increments up to the MTD.
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| United States, California | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94305 | |
| United States, New York | |
| Long Island Jewish Medical Center | |
| New Hyde Park, New York, United States, 11041 | |
More Information
| ClinicalTrials.gov Identifier: | NCT00022880 History of Changes |
| Other Study ID Numbers: | CP-98-018 |
| Study First Received: | August 15, 2001 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Lymphocytic Leukemia Dose-Escalation Radioimmunotherapy Monoclonal Antibody Corixa |
Bexxar Anti-B1 Antibody Tositumomab Iodine -131 Anti-B1 Antibody Iodine I 131 Tositumomab |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell 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 |