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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00081172 |
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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: lutetium Lu 177 monoclonal antibody J591 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Of Lu Radiolabeled Monoclonal Antibody HuJ591-GS (Lu-J591) In Patients With Metastatic Androgen-Independent Prostate Cancer |
Study Start Date: | January 2004 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Progressive disease after prior antiandrogen therapy, as evidenced by at least 1 of the following parameters:
Rising prostate-specific antigen (PSA) despite adequate medical or surgical castration therapy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Concurrent luteinizing hormone-releasing hormone (LHRH) analog allowed provided 1 of the following is true:
Radiotherapy
Surgery
Other
At least 1 week since prior antiplatelet medication, including the following:
No concurrent anticoagulant medications (for platelet count < 50,000/mm^3), including the following:
United States, New York | |
Herbert Irving Comprehensive Cancer Center at Columbia University | |
New York, New York, United States, 10032 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 | |
New York Weill Cornell Cancer Center at Cornell University | |
New York, New York, United States, 10021 |
Study Chair: | Michael Morris, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000360629, MSKCC-03144 |
Study First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00081172 |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer |
Antibodies, Monoclonal Antibodies Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Prostatic Neoplasms Recurrence Immunoglobulins Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |