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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01183598
First received: August 13, 2010
Last updated: February 15, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Castleman's Disease
 Drug: tocilizumab [RoActemra/Actemra]
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays [ Time Frame: up to 90 days after discontinuation of treatment ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: July 2006
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
maintenance dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183598

Locations
United States, Arkansas
Little Rock, Arkansas, United States, 72205-7199
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01183598     History of Changes
Other Study ID Numbers: WA19847
Study First Received: August 13, 2010
Last Updated: February 15, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Giant Lymph Node Hyperplasia
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013