Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)

Summary

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.

Conditions

• Diffuse Intrinsic Pontine Glioma

Interventions

DRUG

Bevacizumab

DRUG

Erlotinib

DRUG

Temozolomide

RADIATION

Radiation

Sponsors & Collaborators

• Boston Children's Hospital

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• Children's Healthcare of Atlanta

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospital of Michigan

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Cook Children's Medical Center

  collaborator OTHER

• OHSU Doernbecher Children's Hospital

  collaborator OTHER

• Duke University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital

  collaborator OTHER

• Nemours Children's Clinic

  collaborator OTHER

• New York University

  collaborator OTHER

• Milton S. Hershey Medical Center

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• Lucile Packard Children's Hospital

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• Children's National Research Institute

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• Phoenix Children's Hospital

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Karen D. Wright MD

  lead OTHER

Principal Investigators

• Karen D. Wright, MD · Dana-Farber Cancer Institute

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2016-06-30

Completion

2016-06-30

Countries

• United States

Study Locations