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A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. PURPOSE: This phase II trial is studying how well radiolabeled monoclonal antibody works in treating patients with progressive metastatic androgen-independent adenocarcinoma (cancer) of the prostate.
OBJECTIVES: Primary * Determine the prostate-specific antigen (PSA) response rate in patients with progressive metastatic androgen-independent adenocarcinoma of the prostate treated with lutetium Lu 177 monoclonal antibody J591. * Determine the measurable disease response rate in patients treated with this drug. Secondary * Determine the toxicity of this drug in these patients. * Determine the duration of biochemical PSA and/or measurable disease response in patients treated with this drug. * Determine the incidence of human anti-J591 antibody (HAHA) response in patients treated with this drug. * Correlate hematological toxicity of this drug with bone marrow involvement (bone scan index) in these patients. * Determine the survival rate in patients treated with this drug. * Determine the targeting of this drug to known tumor sites in these patients. * Determine the tumor-absorbed radiation dose in patients treated with this drug. OUTLINE: This is a multicenter, open-label study. Patients receive a single dose of lutetium Lu 177 monoclonal antibody J591 IV on day 1. Patients then undergo radionuclide scanning between days 6-8 to confirm tumor targeting by the study drug. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 17-32 patients will be accrued for this study.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York Weill Cornell Cancer Center at Cornell University
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
Start Date
January 1, 2004
Completion Date
May 1, 2006
Last Updated
July 10, 2013
lutetium Lu 177 monoclonal antibody J591
RADIATION
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT06842498
NCT05691465
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04550494