Ph I Zactima + Imatinib Mesylate & Hydroxyurea for Pts w Recurrent Malignant Glioma

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

April 30, 2009

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Zactima, Gleevec, Hydroxyurea

"Pts will start treatment on day 1 of cycle 1 w Zactima, imatinib mesylate \& hydroxyurea. All 3 agents administered in continuous daily, oral manner. Imatinib mesylate dose 400 mg/day for pts not on EIAEDs \& 1000 mg/day for pts on EIAEDs based on previous studies demonstrating that pts on EIAEDs require significantly higher doses of imatinib mesylate \& that such doses are safe \& well tolerated. Dose of hydroxyurea 500 mg twice day. Dose level of Zactima will be increased in successive cohorts of pts as described below.~Cohorts of 3-6 pts will accrue at each dose level until MTD is defined. Each cohort will consist of a mini of 3 newly enrolled pts. Intra-patient dose escalation is not permitted. Cohorts may be expanded at any dose level for further elaboration of safety \& pharmacokinetic parameters as required.~Treatment cycle is defined as daily administration of Zactima + imatinib mesylate \& hydroxyurea for 28 days for purpose of scheduling evaluations."

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors
All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

collaborator

AstraZeneca

INDUSTRY

lead

Annick Desjardins

OTHER