Ph I Gleevec in Combo w RAD001 + Hydroxyurea for Pts w Recurrent MG

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

May 31, 2005

Primary Completion Date

August 31, 2008

Study Completion Date

January 31, 2013

Conditions
GlioblastomaGliosarcoma
Interventions
DRUG

Gleevec, RAD001, and Hydroxyurea

Dose of Gleevec will be 400 mg in 1st cohort \& will be increased to 600 mg po/day \& then to 400 mg bid in successive cohorts. Prescribed dose should be administered orally, w large glass of water. Pts should not eat large or high fat meal within 1 hour before or after gleevec dosing. Doses of 600 mg or less should be administered once daily, whereas doses greater than 600 mg should be administered as equal doses twice day. It is recommended that pts take their prescribed Gleevec at same time that they take their prescribed RAD001 \& hydroxyurea, however, 30-60 minute interval between agents is acceptable if required for practical or other compliance issues.

Trial Locations (1)

27710

Duke University Health System, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Pharmaceuticals

INDUSTRY

lead

Annick Desjardins

OTHER