Actively Recruiting
Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma
Led by Children's Oncology Group · Updated on 2026-05-05
54
Participants Needed
20
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and/or effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.
CONDITIONS
Official Title
Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 12 months to less than 18 years for dose escalation phase and 12 months to less than 22 years for disease expansion phase
- Newly diagnosed primary high-grade glioma, diffuse midline glioma (excluding primary spinal tumors), or diffuse intrinsic pontine glioma eligible for 54-59.4 Gy fractionated radiation
- Histologic confirmation required except for typical DIPG
- Patients with supratentorial tumors including various high-grade gliomas and non-pontine diffuse midline gliomas require histologic diagnosis
- Patients with infratentorial tumors typical DIPG by imaging without histology or biopsy-proven high-grade gliomas
- Measurable or non-measurable disease after surgery
- Karnofsky score ≥ 50% for patients over 16 years, Lansky score ≥ 50% for 16 years and younger
- No prior cancer therapy except surgery and/or corticosteroids with stable or decreasing steroid dose
- Adequate blood counts and organ function within 7 days prior to enrollment
- Ability to swallow whole tablets (no nasogastric or gastric tubes)
You will not qualify if you...
- Pregnant or breastfeeding females; females of childbearing potential and males must use effective contraception during and after study as specified
- Currently receiving other investigational drugs or anti-cancer agents except corticosteroids
- Receiving anti-graft versus host disease medications post bone marrow transplant
- Taking strong inhibitors or inducers of CYP3A4/5 enzymes
- Received enzyme-inducing anticonvulsants within 14 days prior to enrollment
- Uncontrolled infection or prior solid organ transplant
- Unable to comply with safety monitoring or rapidly declining neurological status
- Conditions affecting drug absorption (e.g., short gut syndrome), inability to swallow whole tablets
- Known macular degeneration, uncontrolled glaucoma, cataracts
- Primary spinal cord high-grade gliomas or metastatic disease
- Gliomatosis involving at least 3 brain lobes except H3 K27M-mutant bithalamic tumors
- Infant-type hemispheric high-grade gliomas or BRAFV600E mutations
- History of prior radiotherapy as anti-cancer therapy
- Presence of myopathy or elevated creatine kinase >5x upper limit of normal on two occasions
- Clinically significant cardiac dysfunction or prolonged QTc >450 msec
- Known hepatitis B or C with detectable viral load
- Any medical condition compromising safety or study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 20 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Children's Hospital of Orange County
Orange, California, United States, 92868
Actively Recruiting
4
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
5
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
7
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
8
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
9
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
11
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
12
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
13
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
14
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
15
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
17
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
18
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
19
UMC Cancer Center / UMC Health System
Lubbock, Texas, United States, 79415
Actively Recruiting
20
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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