Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
NCT ID: NCT00904735
Last Updated: 2013-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
76 participants
INTERVENTIONAL
2009-06-30
Brief Summary
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PURPOSE: This randomized phase II trial is studying how well hydroxyurea works compared with giving hydroxyurea together with imatinib mesylate in treating patients with recurrent or progressive meningioma.
Detailed Description
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Primary
* Assess the progression-free survival of patients with recurrent or progressive meningiomas treated with hydroxyurea with vs without imatinib mesylate after surgery and radiotherapy.
Secondary
* Determine the overall survival, and response rate of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to WHO grade (I vs II-III). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for up to 1 year.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
NONE
Study Groups
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Arm I
Patients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
hydroxyurea
Given orally
imatinib mesylate
Given orally
Arm II
Patients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
hydroxyurea
Given orally
Interventions
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hydroxyurea
Given orally
imatinib mesylate
Given orally
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Istituto Scientifico H. San Raffaele
OTHER
Principal Investigators
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Alba A. Brandes, MD
Role: STUDY_CHAIR
Ospedale Bellaria
Locations
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Ospedale Civile Avellino
Avellino, , Italy
Ospedale Bellaria
Bologna, , Italy
Azienda Ospedaliero Careggi
Florence, , Italy
Istituto Nazionale Neurologico Carlo Besta
Milan, , Italy
Ospedale Civile di Rovigo
Rovigo, , Italy
Countries
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Facility Contacts
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Contact Person
Role: primary
Alba A. Brandes, MD
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Other Identifiers
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CDR0000641101
Identifier Type: REGISTRY
Identifier Source: secondary_id
NOVARTIS-SRSI-GICNO-08-002
Identifier Type: -
Identifier Source: secondary_id
SRSI-GICNO-08-002
Identifier Type: -
Identifier Source: org_study_id