Monoclonal Antibody Therapy in Treating Patients With Myelodysplastic Syndrome or Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
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|ClinicalTrials.gov Identifier: NCT00002890|
Recruitment Status : Completed
First Posted : August 11, 2004
Last Update Posted : June 25, 2013
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid leukemia or chronic myelogenous leukemia.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Biological: lintuzumab||Phase 1|
OBJECTIVES: I. Determine the safety and toxicity of yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195) in patients with relapsed or refractory myeloid malignancies. II. Determine the pharmacology and dosimetry of 90Y-MOAB HuM195. III. Study the biological effects of 90Y-MOAB HuM195, including the ability to elicit human anti-human antibody responses and antileukemic responses.
OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195). All patients receive a single intravenous dose of 90Y-MOAB HuM195. Groups of 3 to 6 patients are treated at escalated doses of yttrium-90 until the MTD is determined. Patients with active leukemia who exhibit at least a 50% clearing of marrow blasts after the first dose may receive a second dose after 4-8 weeks provided remaining blasts are CD33-positive, there is no evidence of human anti-human antibody response, and any toxicity has resolved. All patients are followed monthly for 4 months after treatment.
PROJECTED ACCRUAL: Up to 24 patients will be treated. The study is expected to require 12-18 months to complete.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Official Title:||PHASE I DOSE-ESCALATION TRIAL OF YTTRIUM-90-LABELED HuM195 (HUMANIZED ANTI-CD33) IN PATIENTS WITH ADVANCED MYELOID MALIGNANCIES|
|Study Start Date :||October 1996|
|Actual Primary Completion Date :||January 2001|
|Actual Study Completion Date :||January 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002890
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||Joseph G. Jurcic, MD||Memorial Sloan Kettering Cancer Center|