Spots Global Cancer Trial Database for Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

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Trial Identification

Brief Title: Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate

Official Title: A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer

Study ID: NCT00081172

Conditions

Prostate Cancer

Interventions

lutetium Lu 177 monoclonal antibody J591

Study Description

Brief Summary: 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.

Detailed Description: 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.