Imatinib Mesylate and Hydroxyurea in Treating Patients With Recurrent or Progressive Meningioma

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

March 31, 2009

Study Completion Date

October 31, 2010

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

hydroxyurea

Hydroxyurea is administered orally twice a day. The dose will be set at 500 mg twice a day for all patients. If vomiting occurs not additional trial medication should be taken that day in an effort to replace the material that has been vomited. It is recommended that patients take their prescribed hydroxyurea at the same time that they take their prescribed imatinib mesylate, however, a 30-60 minute interval between agents is acceptable, if required for practical or other compliance issues.

DRUG

imatinib mesylate

"Imatinib administered orally on daily, continuous basis. Imatinib doses of 400mg/600mg administered once daily, whereas daily doses of 800mg/greater administered as equally divided dose taken twice day.~Dose for Imatinib:~Patients receiving p450-inducing antiepileptic drugs:500mg twice day Patients not receiving p450-inducing antiepileptic drugs:400mg/day.~If patients who were not on Cytochrome P450, family 3, subfamily A (CYP3A) enzyme-reducing anti-epileptic drug (EIAED) when originally enrolled must initiate CYP3A enzyme-inducing anti-epileptic drug while on study, study regimen will remain same for minimum of 2 wks before pt transitions to dosing as specified for patients on anti-epileptic drug. If patients originally enrolled must discontinue all EIAEDs while on study, in interest of patient safety, dosing of study regimen will transition to that of patients not on anti-epileptics immediately."

Trial Locations (1)

27710

Duke Cancer Institute, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Duke University

OTHER