Hydroxyurea With or Without Imatinib Mesylate in Treating Patients With Recurrent or Progressive Meningioma

Istituto Scientifico H. San Raffaele

Status and phase

Unknown

Phase 2

Conditions

Brain and Central Nervous System Tumors

Treatments

Drug: imatinib mesylate

Drug: hydroxyurea

Study type

Interventional

Funder types

Other

Identifiers

NCT00904735

SRSI-GICNO-08-002

NOVARTIS-SRSI-GICNO-08-002

CDR0000641101 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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