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

NCT ID: NCT00040586

Last Updated: 2007-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Detailed Description

In this Phase II, open label study, patients will receive daily low-dose subcutaneous rIL-2 (1.2 x 10^6 IU/m^2/day) continuously beginning on day 1. Patients will receive 3 weeks of IL-2, and on day 22 will receive the monoclonal antibody huJ591 via I.V. (25mg/m^2) for 3 consecutive weeks. Il-2 will be continued for 2 additional weeks for a total of 8 weeks. The 8 week regimen will constitute 1 cycle of therapy. Patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Monoclonal Antibody J591

Intervention Type: DRUG

Recombinant Interleukin-2

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

BZL Biologics

INDUSTRY

Sponsor Role: lead

Locations

New York Presbyterian Hospital Medical Oncology/Urology Clinics

New York, New York, United States

Countries

United States

Other Identifiers

1100-471

Identifier Type: -

Identifier Source: org_study_id