A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

• Status: Completed
• Trial end date: 2017-02-24
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate that CNTO 328 when administered in combination with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic response (complete response or partial response) among patients with Multicentric Castleman's Disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Treatments: Antibodies, Monoclonal; Siltuximab

Criteria

Inclusion Criteria:

• Measurable and symptomatic Multicentric Castleman's Disease

• Adequate organ function as assessed by laboratory values evaluated by the investigator to determine eligibility prior to treatment

• Eastern Cooperative Oncology Group 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:

• Human Immunodeficiency Virus or Human Herpes Virus-8 positive

• Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease

• Previous history of lymphoma

• Malignancies, except for adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which the patient has been disease-free for 3 or more years

• Concurrent medical condition or disease that may interfere with study participation

• Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies