Prostate Cancer Clinical Trial
Official title:
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.
;
Masking: Open Label, Primary Purpose: Treatment
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