A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment
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This open-label, single center study will provide RoActemra/Actemra (tocilizumab) to a maximum of 4 patients with Multicentric Castelman's Disease who have demonstrated benefit from RoActemra/Actemra in study MRA004US (Chugai Pharma USA) without major toxicities or significant adverse events. Patients will receive their most effective maintenance dose until disease progression or significant toxicity occurs.
Efficacy: Maintenance of hemoglobin >/=10.5 g/dL, of Zubrod Performance Status, and of improvement in fatigue and anorexia as per National Cancer Institute Common Toxicity Criteria (NCI CTC) scales [ Time Frame: until disease progression or significant toxicity occurs ]
Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays [ Time Frame: up to 90 days after discontinuation of treatment ]
Provision of tocilizumab for treatment of Multicentric Castleman's Disease to patients with evidence of clinical benefit in response to tocilizumab [ Time Frame: until disease progression or significant toxicity occurs ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients, >/= 18 years of age
Evidence of improvement of one or more clinical benefit criteria with acceptable tolerability to RoActemra/Actemra in Protocol MRA001US, maintained clinical benefit in MRA004US, and completion of MRA004US
Life expectancy > 12 weeks
Zubrod performance status </= 3
Serious toxicity including anaphylactic reactions to tocilizumab during the MRA004US trial
Any treatment for Multicentric Castleman's Disease except for corticosteroids within 2 weeks prior to Day 1
Active infection requiring iv antibiotics for > 1 month and not resolving at least 1 week prior to Day 1; iv antibiotics prophylaxis for infections of implanted venous access portals is allowed
Active viral infection within 28 days prior to Day 1
Treatment with any investigational agent other than RoActemra/Actemra within 30 days prior to baseline