Phase II monitored clinical trial for evaluation of treatment of patients with Thymic Epithelial Tumours(TET) or Histiocitosi X (LCH) with Imatinib Mesylate. - TETIMAX

• Conditions: Patients affected by TET or LCH

• Registration Number: EUCTR2007-006119-22-IT
• Lead Sponsor: IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-01
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

2.TET or LCH confirmed by istological analisys
3.Patients that have received at least one line of treatment with progression of disease
4.Immunoistochemical evaluation
expression of cKIT, PDGFRα, PDGFRβ, m-TOR, p-AKT in LCH patints ,
expression of EGFR, c-KIT, COX-in TET patients.
5.Age from 18 to 75 years old
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnat womeni, childbearing or in fertile period without anticonceptional measures
2.Non measurable lesion as unique site of disease
3. Important disease that can give at the patient high risk of injury

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine the efficacy of treatment with imatinib mesylate in patients affected by refractory TET or LCH. Evaluation of activity<br>will be based on complete pathological response (according to RECIST criteria).;Secondary Objective: 2. Evaluation of safety and toxicity (according to NCI criteria), quality of life (according to EORTC QLQ-C30).<br>3. Identification of predictive biological markers of clinical response: pharmacogenomic and immunological parameters.;Primary end point(s): Determine the efficacy of treatment with imatinib mesylate in patients affected by refractory TET or LCH. Evaluation of activity<br>will be based on complete pathological response (according to RECIST criteria).