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

NCT01183598 | Completed Phase 1

• 1 other identifier: WA19847
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Castleman's Disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: tocilizumab [RoActemra/Actemra]

Interventions

tocilizumab [RoActemra/Actemra] DRUG

maintenance dose

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Little Rock, Arkansas, 72205-7199, United States

Location

MeSH Terms

Conditions

Castleman Disease

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 17, 2010
• Study Start: August 1, 2006
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)