Status:
UNKNOWN
Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
Lead Sponsor:
Istituto Scientifico H. San Raffaele
Conditions:
Brain and Central Nervous System Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate m...
Detailed Description
OBJECTIVES: Primary * Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiothe...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosed with meningioma
- WHO grade I-III
- Recurrent or progressive disease after prior surgery and radiotherapy, or radiosurgery
- Not amenable to further surgery
- No optic nerve sheet tumor and neurofibromatosis type II
- No known brain metastasis
- PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- ANC \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hemoglobin ≥ 9 mg/dL (transfusion allowed)
- Total bilirubin \< 1.5 times upper limit of normal (ULN)
- SGOT and SGPT \< 2.5 times ULN
- Creatinine \< 1.5 times ULN
- Negative pregnancy test
- Fertile patients must use effective barrier method contraception during and for up to 3 months after completion of study therapy
- No second malignancy
- No known chronic liver disease (i.e., active hepatitis, cirrhosis)
- No known HIV infection
- No significant history of non-compliance to medical regimens or inability to grant reliable informed consent
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent enzyme-inducing anti-epileptic drugs
- No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin®)
- Low-molecular weight heparin (e.g., Lovenox) or heparin allowed
- Mini-dose Coumadin® (e.g., 1 mg QD) allowed for prophylaxis of central venous catheter thrombosis, at the discretion of the treating physician
- No concurrent acetaminophen (Efferalgan®, Tachipirina®) allowed during imatinib mesylate administration
- No other concurrent anticancer agents, including chemotherapy or biological agents
- No other concurrent investigational drugs
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00904735
Start Date
June 1 2009
Last Update
August 12 2013
Active Locations (5)
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1
Ospedale Civile Avellino
Avellino, Italy
2
Ospedale Bellaria
Bologna, Italy, I-40139
3
Azienda Ospedaliero Careggi
Florence, Italy, 50139
4
Istituto Nazionale Neurologico Carlo Besta
Milan, Italy, 20133