A Phase IA Trial of Combined Murine IgG Monoclonal Anti-Transferrin Receptor Antibodies E2.3 and A27.15 in Cancer Patients
OBJECTIVES: I. Determine the toxicities associated with a 4-hour infusion of antitransferrin
receptor antibodies with one antibody administered by itself for 1 hour before the second
antibody infusion is started. II. Determine the pharmacokinetics of monoclonal antibodies
E2.3 and A27.15.
OUTLINE: This is a dose escalating study. Patients receive antitransferrin antibody A27.15
IV over 4 hours. One hour after the initiation of the A27.15 infusion, infusion of antibody
E2-3 is added by IV piggy back. In the absence of antimouse antibodies and toxic effects,
treatment continues once every 4 weeks in patients achieving minimal, partial, or complete
remission. Treatment ceases in patients experiencing stable or progressive disease. In the
absence of dose limiting toxicity in the first 3 patients treated, subsequent cohorts of 6
patients each receive escalating doses of antitransferrin antibodies E2.3 and A27.15 on the
same dose schedule. If dose limiting toxicity occurs in 2 of 6 patients at a given dose
level, then dose escalation ceases and the next lower dose is declared the MTD. Patients are
followed for 3 weeks.
PROJECTED ACCRUAL: This study will accrue 18-27 patients within 2 years.
Primary Purpose: Treatment
Michael Lobell, MD
University of Arizona
United States: Federal Government
|Arizona Cancer Center||Tucson, Arizona 85724|