A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment

Conditions
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Castleman's Disease

Intervention / Treatment
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* Drug: tocilizumab [RoActemra/Actemra]


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* maintenance dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | until disease progression or significant toxicity occurs | 
| Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays |  | 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 |  | until disease progression or significant toxicity occurs |