Phase I Trial of Monoclonal Antibody muJ591 in Patients With Hormone-Independent Prostate Cancer
OBJECTIVES: I. Define the toxicity and maximum tolerated dose of monoclonal antibody muJ591
in patients with hormone independent prostate cancer. II. Define the pharmacokinetics and
biodistribution of monoclonal antibody muJ591 in these patients. III. Define the human
antimouse antibody response to this therapy. IV. Define the preliminary efficacy of this
therapy in these patients.
OUTLINE: This is a dose escalation study. Patients receive a single dose of intravenous
iodine I 131-labeled monoclonal antibody muJ591 on day 0, combined with an unlabeled (cold)
dose of monoclonal antibody muJ591. Anterior and posterior imaging is obtained 1 hour after
labeled muJ591 administration and on days 0, 2, 4, and 6. Subsequent cohorts of 3-6 patients
receive fixed iodine-labeled doses with escalating cold doses of monoclonal antibody muJ591
until the maximum tolerated dose is reached. Patients are followed for a minimum of 8 weeks
after muJ591 therapy or until disease progression. Patients with stable or responding
disease who are human anti-mouse antibody negative may receive subsequent treatments at the
discretion of the principal investigator.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Primary Purpose: Treatment
Neil H. Bander, MD
Weill Medical College of Cornell University
United States: Federal Government
|New York Presbyterian Hospital - Cornell Campus||New York, New York 10021|