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

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

Genetic and Rare Diseases Information Center resources: Castleman Disease Angiofollicular Lymph Hyperplasia Angiomatous Lymphoid Hamartoma Unicentric Castleman Disease Multicentric Castleman Disease

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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 ]
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 ]


Enrollment:	3
Study Start Date:	August 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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01183598 History of Changes
Other Study ID Numbers:	WA19847
Study First Received:	August 13, 2010
Last Updated:	September 1, 2016
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 September 30, 2016