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Castleman’s Disease

The Castleman's Study (2366)
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
Status Conditions Phase Study ID
Closed Lymphoproliferative Disease Phase II 2366.00
NCT01024036
Summary

The study is being conducted to demonstrate that CNTO 328 in combination with best supportive care is superior to best supportive care in terms of durable tumor and symptomatic response (reduction in tumor size and the symptoms for at least 18 weeks) and has an acceptable benefit risk profile in among patients with multicentric Castleman's disease.


Investigator
Corey Casper
Location    
SCCA Network 206-288-7232 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Measureable and symptomatic Multicentric Castleman's Disease
  • Adequate organ function as assessed by Laboratory values evaluated by the investigator to determine eligibility prior to treatment
  • ECOG Performance Status of 0, 1, or 2
  • Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained stable or decreased over the 4 weeks before treatment

Exclusion Criteria:

  • HIV or HHV-8 positive
  • Skin lesions as sole measurable manifestation of MCD
  • Prior exposure to IL-6 or IL-6 receptor targeted therapies
  • Previous lymphoma
  • Certain Malignancies, from which the patient has been disease-free for = 3 years
  • Concurrent medical condition or disease that may interfere with study participation
Last Updated
October 16, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.