Leukemia Clinical Trial
Official title:
Phase I/II Trial Of Sequential Therapy With Cytarabine And Bismuth-213-Labeled HuM195 (Humanized Anti-CD33) In Patients With Advanced Myeloid Malignancies
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may
kill more cancer cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining chemotherapy and
monoclonal antibody therapy in treating patients who have advanced myeloid cancer.
OBJECTIVES:
- Determine the maximum tolerated dose of bismuth Bi 213 monoclonal antibody M195
following cytarabine in patients with advanced myeloid malignancies.
- Determine the antileukemic effects of this treatment in this patient population.
- Determine the toxicity of this treatment in this patient population.
- Determine the complete remission rate of patients treated with this treatment regimen.
OUTLINE: This is a dose escalation study of bismuth Bi 213 monoclonal antibody M195 (Bi213
MOAB M195).
Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14,
patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days.
Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the
final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment
continues in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients
experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are
treated at the MTD.
Patients are followed twice weekly for 4 weeks and then monthly for 3 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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