Phase II Trial of Molecularly Determined Treatment of Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas

NCT01182350 Phase 2 TERMINATED Results posted

Diagnosis of diffuse intrinsic pontine glioma (DIPG) for decades has relied on imaging studies and clinical findings. Histologic confirmation has been absent with surgical biopsy of brainstem tumors not believed to have acceptable safety. The prognosis of DIPG has remained quite poor and novel therapeutic strategies are needed. This DIPG Biology and Treatment Study (DIPG-BATS) study incorporates a surgical biopsy at presentation using strict preoperative neurosurgical planning and stratifies participants to receive FDA-approved agents chosen on the basis of specific biologic targets. This is the first prospective national clinical trial to examine the feasibility and safety of incorporating surgical biopsy into potential treatment strategies for children with DIPG.

Details

Lead sponsor	Karen D. Wright MD
Phase	Phase 2
Status	TERMINATED
Enrolment	53
Start date	2011-09
Completion	2016-06

Conditions

• Diffuse Intrinsic Pontine Glioma

Interventions

• Bevacizumab
• Erlotinib
• Temozolomide
• Radiation

Primary outcomes

• 9-month Overall Survival (OS) Rate — 9 months
  9-month overall survival is the percentage of participants remaining alive 9 months from registration.

Countries

United States