450 Participants Needed

Targeted Pediatric High-Grade Glioma Therapy

Recruiting at 17 trial locations
LM
DC
AK
KH
Overseen ByKelsey H Troyer, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Nationwide Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.

Who Is on the Research Team?

MF

Maryam Fouladi, MD

Principal Investigator

Nationwide Children's Hospital

ML

Margot Lazow, MD

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

Inclusion Criteria

Age: Patients must be ≥12 months and ≤30 years of age at the time of enrollment onto this screening protocol.
Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. The diagnosis of HGG must have been confirmed by local pathology review. for the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.
Disease Status: There are no disease status requirements for enrollment.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Molecular Profiling

Comprehensive molecular screening of tumor tissue using a multi-omic approach to determine eligibility for treatment arms

4 weeks
1 visit (in-person)

Treatment

Patients are stratified to biologically-targeted treatment arms based on tumor molecular profile and histopathology

10-35 days post-radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including longitudinal evaluation of biomarkers

4 years

What Are the Treatments Tested in This Trial?

Interventions

  • Targeted Pediatric High-Grade Glioma Therapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nationwide Children's Hospital

Lead Sponsor

Trials
354
Recruited
5,228,000+
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