Brain and Central Nervous System Tumors
Conditions
Keywords
adult grade I meningioma, adult grade II meningioma, adult anaplastic meningioma, adult papillary meningioma, recurrent adult brain tumor
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 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether hydroxyurea is more effective when given alone or together with imatinib mesylate in treating patients with meningioma. 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
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 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.
Interventions
DRUGhydroxyurea
Given orally
DRUGimatinib mesylate
Given orally
Sponsors
Istituto Scientifico H. San Raffaele
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival | — |
| Response rate according to MacDonald criteria | — |
| Toxicity as assessed by NCI CTCAE v. 3.0 | — |
Countries
Italy
Outcome results
None listed