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

Castleman's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01183598
• Other study ID #: WA19847
• Status: Completed
• Phase: Phase 1
• First received: August 13, 2010
• Last updated: November 1, 2016
• Start date: August 2006
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Castleman's Disease
• Giant Lymph Node Hyperplasia

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
maintenance dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Safety: Adverse events, laboratory parameters, vital signs, electrocardiograms, chest X-rays		up to 90 days after discontinuation of treatment	No
Primary	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	No