Prostate Cancer Clinical Trial
Official title:
Phase I Evaluation of 131I-J591 Murine Monoclonal Antibody in Patients With Progressive Androgen-Independent Prostate Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
tumor-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 prostate cancer that no longer responds to antiandrogen therapy.
OBJECTIVES: I. Determine the biodistribution and normal organ dosimetry of iodine I 131
monoclonal antibody muJ591 in patients with progressive androgen independent prostate
cancer. II. Determine the safety of this drug in these patients. III. Determine the
pharmacokinetics of this drug in these patients. IV. Determine the human antimouse antibody
response in these patients to this drug. V. Determine the antitumor effects of this drug in
these patients.
OUTLINE: This is a dose escalation study of iodine I 131 monoclonal antibody muJ591
(131I-J591). Patients receive unlabeled monoclonal antibody muJ591 IV over 1 hour followed
by 131I-J591 IV over 1 hour. Cohorts of 3-6 patients receive escalating doses of 131I-J591
(radioactivity is escalated, monoclonal antibody dose is fixed) 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. Patients are followed at weeks 3, 4, 6, 8, 9, and 12, and
then every 6 months until month 21.
PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study over 12 months.
;
Primary Purpose: Treatment
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