patients affected by recurrent or progressive meningiomas
Conditions
Interventions
Trade Name: GLIVEC
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: IMATINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Trade Name: ONCOCARBIDE*2
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Countries
Italy
Outcome results
None listed