Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of patients with metastatic, androgen-independent prostate cancer.

Key facts

Study ID

NCT00195039

Run by

Weill Medical College of Cornell University

People needed

47

Starts

2004-08-01

Expected to finish

2013-10-01

Last updated by the study team

2017-10-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of prostate adenocarcinoma.
• Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite adequate medical or surgical castration therapy.
• Progressed following discontinuation of anti-androgen therapy, if received.
• Serum testosterone < 50 ng/ml

You may not qualify if…

• Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
• Use of PC-SPES within 4 weeks of treatment.
• Use of red blood cell or platelet transfusions within 4 weeks of treatment.
• Use of hematopoietic growth factors within 4 weeks of treatment.
• Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
• Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
• Prior radiation therapy encompassing >25% of skeleton.
• Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
• Active angina pectoris or NY Heart Association Class III-IV.
• History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
• Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
• Prior monoclonal antibody therapy with the exception of ProstaScint®
• Prior investigational therapy (medications or devices) within 6 weeks of treatment.
• Known history of HIV

Where it is running

• Weill Medcial College of Cornell University — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.