Phase II Trial of Monoclonal Antibody J591 in Combination With Low-Dose Interleukin-2 in Patients With Recurrent Prostate Cancer
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
|New York Presbyterian Hospital Medical Oncology/Urology Clinics||New York, New York 10021|