Can a Tumor's genetic blueprint guide better treatment for kids with brain cancer?
NCT ID NCT03739372
First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time
Summary
This pilot trial explores whether using a tumor's molecular profile—its gene expression and DNA sequencing—can help doctors choose a personalized treatment plan for children and young adults with high-grade glioma (a type of brain cancer). Participants receive a recommendation from a specialized tumor board, which may include up to four FDA-approved drugs based on the tumor's unique characteristics. The study aims to see if this tailored approach can improve progression-free survival and overall survival at 12 months, while also monitoring safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Individualized treatment plan based on molecular profiling, with up to four FDA-approved drugs selected by a specialized tumor board
- What this could lead to
- If successful, this approach could show that tailoring treatment to each tumor's genetic makeup improves survival in children with high-grade glioma.
- What could go wrong
- This is a small pilot study, so results may not be conclusive. The approach depends on the accuracy of molecular profiling and the availability of effective drugs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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44 people
The number who actually took part.
- Started
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Nov 2018
- Finished
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May 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 21 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with newly diagnosed HGG (including midline HGG but excluding DIPG), who undergo tissue collection as part of standard of care. HGG is defined as either World Health Organization (WHO) grade III or IV, or testing positive for H3K27M mutation. Patients with disseminated disease are not eligible, and MRI of the spine must be performed if disseminated disease is suspected by the treating physician. Primary spinal cord tumors are eligible. * Enrollment within 3 weeks of the start of radiation therapy. * Start of radiation therapy within 6 weeks from initial tissue diagnosis. * Age ≤ 21 years * Karnofsky score ≥ 50 for patients ≥ 16 years of age and Lansky score ≥ 50 for patients ≤15 years of age. Patients who are unable to walk because of paralysis but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score * Adequate tissue for molecular profiling (see Section 8 of the protocol for full details) * The effects of the current treatment paradigm on the developing human fetus are unknown. For this reason, females of child-bearing potential and males must agree to use adequate contraception: hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation, and 30 days after completion of study drug administration. Should a female become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Males treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 30 days after completion of study drug administration. * Adequate neurologic function defined as: Patients with seizure disorder may be enrolled if seizures are well controlled. * Ability by patient or parent/legal guardian to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: * Patients who are currently enrolled on another therapeutic clinical trial. Individual cases should be discussed with the study chair. * Patients who are currently taking any anti-cancer directed therapy. Steroids are not considered anti-cancer therapy. The use of temozolomide during radiation therapy is allowed at standard dosing (maximum 75 to 90 mg/m\^2 daily for a total of 42 days). Any other schedule(s) need to be discussed with the study chair. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Female patients of childbearing potential must not be pregnant or breast-feeding. Female patients of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy (as clinically indicated). * Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy. Telemedicine visits are acceptable.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
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Children's Hospitals and Clinics of Minneapolis
Minneapolis, Minnesota, 55404, United States
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Children's National Medical Center
Washington D.C., District of Columbia, 20010, United States
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Johns Hopkins University
Baltimore, Maryland, 21218, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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Seattle Children's Hospital
Seattle, Washington, 98105, United States
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The Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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University of California, San Diego Rady Children's Hospital
San Diego, California, 92123, United States
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University of California, San Francisco
San Francisco, California, 94158, United States
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University of Florida
Gainesville, Florida, 32611, United States
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University of Utah
Salt Lake City, Utah, 84112, United States
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Washington University
St Louis, Missouri, 63110, United States
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