Monoclonal Antibody Therapy in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00003391
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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 muJ591 monoclonal antibody in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed Description

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.

Study Timeline

• Study Start: 1998-06
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-07-21
• Study First Posted: 2004-07-22
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-09
• Last Update Posted: 2009-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

New York Presbyterian Hospital - Cornell Campus; 🇺🇸 New York, New York, United States