Phase II Trial of Monoclonal Antibody (J591) in Combination With Low-Dose Subcutaneous Interleukin-2

Completed · Phase 2

Conditions studied: Prostatic Neoplasms

In brief

The monoclonal antibody J591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (Proleukin, Aldesleukin). The study is an open-label, non-randomized phase II study for patients with documented hormone refractory prostate cancer.

Key facts

Study ID

NCT00040586

Run by

BZL Biologics

Last updated by the study team

2007-01-22

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may not qualify if…

• Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of entry.
• History of CNS metastasis, and/or history of seizure and/or stroke.
• Lab values: ANC<1500/mm3; platelet count<100,000/mm3; serum creatinine>2.0; SGOT>2 x normal; bilirubin (total)>1.5; serum calcium> or equal to 11.5.
• Active serious infection not controlled by antibiotics.
• Active angina pectoris or NYHA Class III-IV.
• Karnofsky Performance Status <60.
• Life Expectancy < 3 months.
• Age< 21y.
• 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.
• Untreated thyroid disease, with the exception of treated and stable hyperthyroidism or hypothyroidism for at least 4 weeks prior to entry.

Where it is running

• New York Presbyterian Hospital Medical Oncology/Urology Clinics — New York, New York, United States

Full record on ClinicalTrials.gov

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