A Phase I Study of B43-Genistein Immunoconjugate in Recurrent B-Lineage Acute Lymphoblastic Leukemia and Non Hodgkin's Lymphoma
OBJECTIVES: I. Determine the maximum tolerated dose of B43-genistein immunoconjugate in
patients with recurrent B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma. II.
Determine the systemic B43-genistein exposure levels in these patients. III. Determine the
antileukemic activity of this regimen in these patients. IV. Monitor the development of
human antimouse antibody in these patients on this regimen.
OUTLINE: This is a dose escalation study. Patients receive B43-genistein immunoconjugate IV
over 1 hour on days 1-3, 8-10, and 15-17. Treatment continues every 3 weeks in the absence
of unacceptable toxicity or until disease progression. Cohorts of 3-6 patients receive
escalating doses of B43-genistein immunoconjugate until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
experience dose limiting toxicity. Patients are followed every 6 months.
PROJECTED ACCRUAL: A minimum of 3-15 patients will be accrued for this study.
Primary Purpose: Treatment
Fatih M. Uckun, MD
Parker Hughes Cancer Center
United States: Federal Government
|Children's Hospital Los Angeles||Los Angeles, California 90027-0700|
|Children's National Medical Center||Washington, District of Columbia 20010-2970|
|Parker Hughes Institute||St. Paul, Minnesota 55113|