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

Prostatic Neoplasms Clinical Trial

Official title: Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT00040586
• Study type: Interventional
• Source: BZL Biologics
• Status: Completed
• Phase: Phase 2