A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6) in Patients with Hormone Refractory Prostate Cancer

Pt must have histo dx of prostate adeno that is metastatic (N1 and/or M1) & deemed unresponsive/refractory to androgen deprivation therapy. Pt must have rec'd only 1 prior chemo regimen which contained either a taxane or mitoxantrone & 28 days must have lapsed. Pt must have current evidence of disease progression as defined in Sect 5.2. Pt must have PSA >/= 5 w/in 28 days prior to reg. Pt must have measurable or non-measurable disease and all disease must be assessed. Pt must have CT or MRI of abd/pelvis w/in 28 days and bone scan w/in 42 days prior to reg. Pt must be castrate. If pt has been tx'd w/non-steroidal antiandrogens, they must have been stopped per Sect 5.7. Prior RT to <30% of bone marrow & prior surgery allowed. Bisphosphonate therapy permitted provided it commenced > 3 wks prior to reg & is maintained. Pt not allowed to start bisphosphonate after reg. Pt must have C-reactive protein, AGC of >/= 1,500, PLT >/= 100,000, HGB >/= 9, calculated CrCl >/=40, bili and SGOT </= 2 x IULN w/in 28 days prior to reg. Testosterone must be obtained. Pt must have Zubrod PS 0-2. Pts w/hx or current brain mets are not eligible. Pt must not be planning to receive other anti-cancer tx. Pt must be offered opportunity to participate in translational medicine studies outlined in Sect 15. Pts w/any uncontrollled intercurrent illness are not eligible. Pts known to be HIV + not eligible. Pt must not have rec'd any murine or chimeric proteins or human/murine mAb w/in 60 days of 1st dose of study agent.