||A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) plus Best Supportive Care Compared With Best Supportive Care in Subjects with Multicentric Castleman’s Disease
||Ortho Biotech Oncology Research & Development, Unit of Centocor Research & Development, Inc.
||Frits van Rhee, MD, PhD
||To demonstrate that CNTO 328 in combination with BSC is superior to BSC in terms of durable tumor and symptomatic response among subjects with MCD.
||The study population will consist of subjects with symptomatic MCD who are 18 years or older and are HIV-negative and HHV-8-negative. About 78 patients will take part in this international study. About 10 participants, male or female, age 18 and older, regardless of race or ethnicity, will participate in this study at UAMS.
||Subjects will receive CNTO 328 (11 mg/kg) or placebo by a 1-hour IV infusion every 3 weeks. Dose modification (increase or decrease) is not permitted. Approximately 78 subjects will be randomly assigned in a 1:2 ratio to placebo + BSC or to CNTO 328 + BSC. The study will be conducted in a blinded manner with independent, centrally confirmed assessment of the diagnosis and radiographic assessment of tumor response.
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