Conditions: Prostate Cancer Neoplasm Metastasis
Keywords: Prostate Cancer Oncology Prostate Cancer Metastatic Hormone PSA Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 75
Healthy volunteers: no

Brief summary:
Multicenter study in which patients with metastatic hormone refractory prostate cancer (HRPC), who have not had previous chemotherapy or immunotherapy treatments, received MDX-010 every 3 weeks for 4 doses (12 weeks total duration of induction). MDX-010 was administered at escalating dosage levels of 3, 5, and 10 mg/kg/dose infusions. At least 6 patients were to be enrolled in each dosage level. Patients who tolerated and responded to treatment or who had stable disease for 3 months or longer and who subsequently progressed during the follow up phase of the study had the option to receive additional treatment with MDX-010, up to 4 cycles. Patients were followed in the study for response up to 2 years and were followed for survival status for up to 5 years after enrollment.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: MDX-010
Intervention descriptions: intervention 1: selected dose administered IV every 3 weeks

Protocol document: