RATIONALE: Monoclonal antibodies can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Radioactive monoclonal antibodies, such as yttrium Y 90 monoclonal antibody, can find cancer cells and either kill them or carry cancer-killing substances to them without harming normal cells. PURPOSE: This phase I trial is studying the side effects and best dose of a yttrium Y 90 monoclonal antibody and how much radiation is taken in by the organs in the body in treating patients with advanced leukemia or other hematologic disorder.
OBJECTIVES: Primary * To establish that a dose of 150 mg/m² of nonradiolabeled anti-CD45 monoclonal antibody AHN-12 results in normal biodistribution, normal-organ estimated radiation-absorbed dose of less than 20 Gy, and estimated radiation-absorbed dose of no more than 13 Gy to the red marrow. Secondary * To determine the maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12). * To determine the human anti-mouse antibody (HAMA) response. * To define, preliminarily, the antitumor activity of \^90Y-AHN-12. OUTLINE: This is a dose-escalation study of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12). * Biodistribution: Patients receive nonradiolabeled monoclonal antibody AHN-12 IV and an imaging dose of indium Y 111 monoclonal antibody AHN-12 (\^111In-AHN-12) IV over 10 minutes on day 0. Patients undergo whole-body gamma-camera imaging immediately following infusion, at 4-6 hours, and on days 1, 3, 4, and 7. Blood samples are collected prior to each imaging for dosimetry calculations and pharmacokinetics. Patients also undergo bone marrow biopsy 16-24 hours after infusion for dosimetry calculations. Patients with the expected biodistribution of \^111In-AHN-12, an estimated radiation-absorbed dose to the normal organ of \< 20 Gy, an estimated radiation-absorbed dose to the red marrow of ≤ 13 Gy, and a negative human anti-mouse antibody at day 7 proceed to the therapy portion. * Treatment: Patients receive nonradiolabeled anti-CD45 monoclonal antibody AHN-12 IV over 60 minutes and escalating therapy doses of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12 (\^90Y-AHN-12) IV over 10 minutes on day 7 or 8. After completion of study treatment, patients are followed periodically for 1 year.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
150 mg/m\^2 cold antibody at Day 0
Dose per scheduled level; 2.5-12.5 mCi/m\^2
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Biodistribution of nonradiolabeled anti-CD45 monoclonal antibody AHN-12
Time frame: Within 1 hour, 4-6 hours, Days 1, 3, 4 and 7 post infusion
Maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody AHN-12
Time frame: Week 8
Presence of human antibody to murine antibody
Time frame: at baseline and at 28 days, 90 days, and 6 months after completion of study treatment
Dose-limiting toxicity and response
Time frame: at days 28 and 90 after completion of study treatment
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