Spots Global Cancer Trial Database for Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
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Trial Identification
Brief Title: Molecularly Determined Treatment of Diffuse Intrinsic Pontine Gliomas (DIPG)
Official Title: Phase II Trial of Molecularly Determined Treatment of Children and Young Adults With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas
Study ID: NCT01182350
Conditions
Study Description
Brief 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.
Detailed Description: The primary objective of this study is to estimate the overall survival of children and young adults with DIPG in the context of a molecularly based treatment strategy, compared to historical controls (COG ACNS0126). Secondary objectives were to determine the safety and potential morbidity associated with biopsy of classic DIPGs based on imaging and clinical history as well as ability to perform biologic analyses on the biopsy material obtained to guide therapy. At study entry, a MRI-guided frameless or frame-based stereotactic biopsy will be performed approaching the pontine termentum through a trans-cerebellar or trans-frontal route. The exact biopsy location will be determined by the treating neurosurgeon at the designated participating site with the goal of minimizing procedural risk. Treatment directed based on tumor biopsy results requires classification of patients into 1 of 4 potential cohorts: O\^6-methylguanine-DNA methyltransferase (MGMT) promoter methylation status (negative versus positive) and epidermal growth factor receptor (EGFR) overexpression status (negative versus positive).
Keywords
Eligibility
Minimum Age: 3 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Phoenix Children's Hospital, Phoenix, Arizona, United States
Children's Hospital Los Angeles, Los Angeles, California, United States
Stanford University/Lucile Packard Children's Hospital, Palo Alto, California, United States
University of California, San Francisco, San Francisco, California, United States
Children's Hospital Colorado, Aurora, Colorado, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Miami Children's Hospital, Miami, Florida, United States
Children's Healthcare of Atlanta, Atlanta, Georgia, United States
Ann & Robert H Lurie Children's Hospital of Chicago, Chicago, Illinois, United States
University of Louisville, Louisville, Kentucky, United States
Johns Hopkins, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States
Washington University Medical Center, Saint Louis, Missouri, United States
New York University, New York, New York, United States
Duke University, Durham, North Carolina, United States
Doernbecher Children's Hospital, Portland, Oregon, United States
Penn State Hershey Medical Center, Hershey, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
UT Southwestern Medical Center, Dallas, Texas, United States
Cook Children's Medical Center, Fort Worth, Texas, United States
Seattle Children's Hospital, Seattle, Washington, United States
Contact Details
Name: Karen D. Wright, MD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR
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