A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 31, 2009

Primary Completion Date

October 31, 2014

Study Completion Date

December 31, 2017

Conditions
Newly Diagnosed High-Grade GliomasDiffuse Intrinsic Pontine Glioma
Interventions
DRUG

Temozolomide

"High Grade Glioma Temozolomide during radiotherapy: 90mg/m2/day PO daily (for patients ≤ 18 years of age); 75mg/m2/day PO daily (for patients ≥ 19 years of age); must begin by Day 5 of radiotherapy for a total of 42 days consecutively.~High Grade Glioma Temozolomide during maintenance chemotherapy: 150mg/m2/day PO on Days 1-5."

DRUG

Bevacizumab

"High Grade Glioma Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Day 22 (± 2 days)and Day 36 (± 2 days) of radiotherapy.~High Grade Glioma Bevacizumab during maintenance chemotherapy:10 mg/kg as a 90 minute infusion on Day 1 (+ 2 days)and Day 15 (± 2 days) of each course.~Diffuse Intrinsic Pontine Gliomas Bevacizumab during radiotherapy: 10 mg/kg as a 90 minute infusion on Days 1 (+ 2 days),15, 29, and 43(±2 days for all 3 doses) of radiotherapy.~Diffuse Intrinsic Pontine Gliomas Bevacizumab during maintenance chemotherapy: 10 mg/kg as a 90 minute infusion on Day 1 (+2 days)and 15 (±2 days)."

DRUG

Irinotecan

"High Grade Glioma Irinotecan during maintenance chemotherapy:125 mg/m2/day IV over 90 minutes on Days 1 (+ 2 days)and 15 (±2 days) of each course, given no sooner than one hour after temozolomide on Day 1.~Diffuse Intrinsic Pontine Gliomas Irinotecan maintenance chemotherapy: 125 mg/m2/day IV on Day 1 (+2 days)and Day 15 (±2 days)."

Trial Locations (2)

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60614

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

lead

Children's Hospital Medical Center, Cincinnati

OTHER

NCT00890786 - A Study of Bevacizumab Therapy in Patients With Newly Diagnosed High-Grade Gliomas and Diffuse Intrinsic Pontine Gliomas | Biotech Hunter | Biotech Hunter