Erlotinib and Radiation Therapy in Treating Young Patients With Newly Diagnosed Glioma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

March 31, 2005

Primary Completion Date

July 31, 2012

Study Completion Date

September 30, 2014

Conditions
Brain and Central Nervous System Tumors
Interventions
DRUG

Erlotinib hydrochloride

This study has 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib will be given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study is 120mg/m2 per day (maximum dose of 200mg per day).

Trial Locations (3)

27710

Duke Children's Hospital and Health Center, Durham

38105

St. Jude Children's Research Hospital, Memphis

92123-4282

University of California San Diego, San Diego

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Rady Children's Hospital, San Diego

OTHER

collaborator

Duke University

OTHER

lead

St. Jude Children's Research Hospital

OTHER