CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0608 (clinicaltrials.gov NCT No: NCT01024036)
Title: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
Principal Investigator:Luis E. Fayad
Treatment Agent:CNTO 328
Study Status:Terminated
Study Description:The goal of this clinical research study is to study the effectiveness of CNTO
328 (Siltuximab) and best supportive care (BSC), compared to BSC alone, in
patients with MCD. The safety of CNTO 328 and its ability to control symptoms
of the disease will also be studied.

Hide details for General InformationGeneral Information

Disease Group:Lymphoma
Phase of Study:Phase II
Treatment Agents:CNTO 328
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Treatment is given in cycles. Each cycle is 21 days. Treatment with study drug
(either CNTO or placebo) occurs on the 1st day of each cycle.
Supported By:Janssen Research & Development, LLC
Return Visit:During cycle 1(Days 1, 8, and 15), participants will visit the doctor 3 times;
off study/end of treatment (30 days after the last does of study drug).
Home Care:NA


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Luis E. Fayad
Dept:Lymphoma/Myeloma
For Clinical Trial Enrollment:713-792-2860
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults