Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate
- Conditions
- Prostate Cancer
- Registration Number
- NCT00081172
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biochemical response as measured by prostate-specific antigen level at 8 weeks after treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
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
Memorial Sloan-Kettering Cancer Center🇺🇸New York, New York, United States