Patients with disease of any major organ system that would compromise their ability to withstand therapy. Patients with disease of any major organ system that would compromise their ability to withstand therapy; any significant organ impairment should be discussed with the study chair prior to patient entry Patients with disease of any major organ system that would compromise their ability to withstand therapy Patients with disease of any major organ system that would compromise their ability to withstand therapy. Patients with disease of any major organ system that would compromise their ability to withstand therapy Patients with disease of any major organ system that would compromise their ability to withstand therapy. Patients with disease of any major organ system that would compromise their ability to withstand therapy.