Phase I Trial of Humanized 1D10 Monoclonal Antibody (Hu1D10) In Patients With Relapsed Non-Hodgkin's Lymphoma (NHL)
I. Assess the safety and tolerability of monoclonal antibody Hu1D10 in patients with
previously treated non-Hodgkin's lymphoma expressing the antigen recognized by Hu1D10.
II. Determine the maximum tolerated dose of monoclonal antibody Hu1D10 in these patients.
III. Evaluate the pharmacokinetics, compare the pharmacology at different dose levels, and
determine the optimal biological dose of this drug in these patients.
IV. Evaluate any antilymphoma effects of this drug in these patients.
OUTLINE: This is a dose escalation, multicenter study.
Patients receive monoclonal antibody Hu1D10 IV over 2-4 hours on days 1, 8, 15, and 22.
Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts
of 3-6 patients receive escalating doses of monoclonal antibody Hu1D10 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6
patients experience dose limiting toxicity. Once the MTD is determined, an additional cohort
of 3-6 patients receive Hu1D10 IV over 2-4 hours on days 1-5.
Patients are followed at 4 weeks, 50 days, and periodically thereafter until disease
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Brian Link, MD
Holden Comprehensive Cancer Center
United States: Food and Drug Administration
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|
|University of Iowa Hospitals and Clinics||Iowa City, Iowa 52242|
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|
|New York Presbyterian Hospital - Cornell Campus||New York, New York 10021|
|Biologics Evaluation Section||Bethesda, Maryland 20892-9903|