An open-label, single-arm, phase II, prospective, pilot study of tocilizumab in patients with Erdheim-Chester disease.

OSPEDALE S. RAFFAELE DI MILANO0 sitesStarted: September 21, 2012Last updated: December 17, 2012

Drugs

Trial Snapshot

No summary available.

•-Patients aged > = 18 years able to understand and sign an informed consent--diagnosis of ECD histologically documented ; -advanced disease limited to the skeleton, with at least one measurable lesion; -disease progression in the course of now most commonly used therapies (eg corticosteroids, interferon-alpha, methotrexate) or a location (such as cardiac or CNS) known to be unresponsive to any of the treatments currently available; -if women of childbearing age are necessary: a negative pregnancy test and the ability to exclude securely the beginning of a pregnancy for the duration of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 4
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•-history of hypersensitivity to tocilizumab or to any of the excipients;-serious infections requiring hospitalization or antibiotic therapy within 30 days before enrollment in the study;-active tuberculosis, listeriosis, histoplasmosis, sepsis, abscesses, opportunistic infections, active HBV or HCV-previous history of tuberculosis (as documented by a positive PPD skin test and / or a positive QuantiFERON test and / or chest radiography), in the absence of documented and appropriate administration of a specific treatment for tuberculosis latent-history of infection with HIV-past history (<5 years before enrollment) of a lymphoproliferative disorder or a solid tumor (excluding treated basal cell or squamous cell carcinoma of the skin);-moderate or severe heart failure (class NYHAIII / IV), uncontrolled diabetes mellitus or other diseases that, in the opinion of the physician responsible for the protocol can be detrimental to the patient if he / she would enroll in the study, history of alcohol-and / or drug abuse - previous treatment with alkylating agents (chlorambucil, cyclophosphamide);-serum creatinine> 1.6 mg / dL in women or> 1.9 mg / dl in male patients, AST and / or ALT = 3 x ULN, platelets <100.000/fL; hemoglobin <8.5 g / dl, WBC <1000 / fL; lymphocytes <500/fL, total bilirubin> 2.0 mg / dL

Sponsor

OSPEDALE S. RAFFAELE DI MILANO