Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
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 monoclonal antibody therapy in treating patients who have recurrent acute lymphoblastic leukemia or non-Hodgkin's lymphoma.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of B43-Genistein Immunoconjugate in Recurrent B-Lineage Acute Lymphoblastic Leukemia and Non Hodgkin's Lymphoma|
|Study Start Date:||March 2000|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004858
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90027-0700|
|United States, District of Columbia|
|Children's National Medical Center|
|Washington, District of Columbia, United States, 20010-2970|
|United States, Minnesota|
|Parker Hughes Institute|
|St. Paul, Minnesota, United States, 55113|
|Study Chair:||Fatih M. Uckun, MD||Parker Hughes Cancer Center|