Radiolabeled BC8 (Anti-CD45) Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Lymphocytic Leukemia
OBJECTIVES: I. Assess the efficacy and toxicity of iodine I 131 monoclonal antibody BC8,
cyclophosphamide, and total body irradiation in patients with advanced acute lymphocytic
leukemia who are receiving HLA matched related or unrelated bone marrow transplantation. II.
Determine the maximum tolerated dose (MTD) of iodine I 131 monoclonal antibody BC8 in these
patients. III. Estimate the MTD of radiation delivered by iodine I 131 monoclonal antibody
BC8 to the marrow. IV. Study the influence of marrow cellularity, level of antigen
expression by leukemic cells, and degree of antigen saturation by antibody on the
biodistribution of iodine I 131 monoclonal antibody BC8 in these patients.
OUTLINE: This is a dose-escalation study. All patients receive a test dose of iodine I 131
monoclonal antibody BC8 (MOAB BC8) IV over several hours 6-14 days prior to the therapeutic
dose. Patients receive the therapeutic dose of iodine I 131 MOAB BC8 IV over several hours
on day -11, total body irradiation over 30-40 minutes twice a day on days -6 to -4, and
cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo allogenic bone marrow
transplantation on day 0. Patients receive intrathecal methotrexate twice prior to
transplantation and then every other week for 4 weeks beginning on day 32 posttransplant.
Cohorts of 4 patients receive escalating doses of iodine I 131 monoclonal antibody until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 4 patients experience dose-limiting toxicity. Patients are followed for the first
100 days, at 6, 9 and 12 months, every 6 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.
Primary Purpose: Treatment
Dana Christine Matthews, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Washington Medical Center||Seattle, Washington 98195-6043|