|Closed||Castleman's Disease||Phase II||
The purpose of this study is to assess the safety of extended treatment with siltuximab in patients who were previously enrolled in sponsor-initiated studies of multicentric Castleman's disease (C0328T03 and CNTO328MCD2001) and are either treatment-naive or have not progressed on siltuximab in the opinion of the investigator.
- Have multicentric Castleman's disease
- Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
- Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose. Patients with longer treatment durations since the last study treatment may be allowed after discussion with the medical monitor
- Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
- Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study
- Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study
- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
- Intervening treatment for Castleman's disease since the previous siltuximab study except for corticosteroids, provided the dose is not exceeding 1 mg/kg/day of prednisone (or equivalent) and remained stable or decreased over the 4 weeks prior to enrollment
- Known unmanageable allergies, hypersensitivity, or intolerance to monoclonal antibodies or to murine, chimeric, or human proteins or their excipients
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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