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lutetium Lu 177 monoclonal antibody J591

Michael Morris, MD

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.

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

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

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate	NCT00081172	Prostate Cancer	lutetium Lu 177...	18 Years -	National Cancer Institute (NCI)
Radiolabeled Monoclonal Antibody in Treating Patients With Progressive Metastatic Androgen-Independent Adenocarcinoma (Cancer) of the Prostate	NCT00081172	Prostate Cancer	lutetium Lu 177...	18 Years -	National Cancer Institute (NCI)

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