TheranosticTrials.org

Clinical Trial · NCT00195039

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

Overview

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.

Sponsor

Weill Medical College of Cornell University

Phase

Phase 2

Contacts

Scott Tagawa, M.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00195039

Drug / Compound

J591

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies
Chelator: DOTA

Eligibility

Inclusion

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

Exclusion

  • Use of PC-SPES within 4 weeks of treatment.
  • Use of hematopoietic growth factors within 4 weeks of treatment.
  • Bone scan demonstrating confluent lesions involving both axial and appendicular skeleton.
  • Prior radiation therapy encompassing \>25% of skeleton.
  • Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.
  • 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 treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®).
  • Active angina pectoris or NY Heart Association Class III-IV.
  • Use of red blood cell or platelet transfusions within 4 weeks of treatment.
  • History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of study entry.
  • Prior investigational therapy (medications or devices) within 6 weeks of treatment.
  • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
  • Known history of HIV