Brain and Central Nervous System Tumors | Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma
Brain and Central Nervous System Tumors research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Brain and Central Nervous System Tumors
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:imatinib mesylateGiven orally
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm IPatients receive oral hydroxyurea twice daily and oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Arm IIPatients receive oral hydroxyurea twice daily in the absence of disease progression or unacceptable toxicity.
Start Date: June 2009
Phase: Phase 2
Primary Outcome: Progression-free survival, defined as ≥ 25% increase in tumor volume or new tumor on MRI
Secondary Outcome: Survival
Study sponsors, principal investigator, and references
Principal Investigator: Alba A. Brandes, MD
Lead Sponsor: Istituto Scientifico H. San Raffaele