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

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.

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Key information

Conditions

Castleman's Disease Castleman Disease Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Little Rock, Arkansas, 72205-7199, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tocilizumab [RoActemra/Actemra]

Drug

maintenance dose

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Aug 17, 2010
Registry last updated: Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed