Imatinib piu` idrossiurea nel trattamento dei meningiomi recidivati o in progressione: studio randomizzato di fase II. - ND

• Conditions: patients affected by recurrent or progressive meningiomas

• Registration Number: EUCTR2008-007988-16-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Patients with WHO grade I-III meningioma.
2. Recurrence after surgery and radiotherapy or radiosurgery
3. Patients not amenable of further surgery.
4. Age: ≥18 yr and ≤75 yr.
5. Performance status: WHO 0-2.
6. Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x UNL , creatinine < 1.5 x ULN.
7. Adequate bone marrow function, defined as the following: ANC >1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level.
8. Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
9.Written, voluntary informed consent.
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.Optic nerve sheet tumors and neurofibromatosis type II.
2. Second malignancies.
3. Anti-epileptic treatment with EIAED
4. Patient has a known brain metastasis.
5. Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
6. Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
7. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective of the study will be to assess the impact of imatinib plus hydroxyurea on PFS in patients with a diagnosis of meningioma recurrent or progressive after surgery and radiotherapy, vs PFS in control group.;Secondary Objective: Overall survival, response rate (RR), and toxicity will also be assessed as secondary objectives.<br>Moreover a translational research will be performed in order to generate hypotheses for further development of meningiomas treatment (e.g. association with somatostatine analogues, treatment duration, role of dose-escalation, predictive tests etc).;Primary end point(s): Progression free survival. Progression defined as at least a 25% increase in tumor volume or new tumor on MRI.