Leukemia Clinical Trial
Official title:
PHASE I DOSE-ESCALATION TRIAL OF YTTRIUM-90-LABELED HuM195 (HUMANIZED ANTI-CD33) IN PATIENTS WITH ADVANCED MYELOID MALIGNANCIES
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.
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.
;
Primary Purpose: Treatment
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