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

Conditions

• Childhood Astrocytoma
• Childhood Diffuse Intrinsic Pontine Glioma
• Childhood Diffuse Midline Glioma
• Childhood Glioblastoma
• Childhood Malignant Glioma

Eligibility Criteria

Sex

ALL

Age

12 Months - 22 Years

Healthy Volunteers

Not accepted

Interventions

• ATM Kinase Inhibitor AZD1390 — DRUG
  Given PO
• Biospecimen Collection — PROCEDURE
  Undergo blood and cerebrospinal fluid collection
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Radiation Therapy — RADIATION
  Undergo radiation therapy
• Survey Administration — OTHER
  Ancillary studies

Study Details

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 repair deoxyribonucleic acid damage caused by cancer treatments, such as radiation therapy. This may help overcome resistance to therapy seen in these cancers and therefore lead to increased death of cancer cells. Radiation therapy uses high energy x-rays or particles to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.

Key Dates

Start date

Jun 18, 2025

Status verified

May 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

54 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (AZD1390 and radiation therapy)
  Patients receive AZD1390 PO once within 5 days prior to radiation therapy. Patients then receive AZD1390 PO QD, 5 days per week, Monday through Friday, and also receive radiation therapy on the same days for approximately 6 weeks. Patients then receive AZD1390 on days 1-14 after radiation in the absence of disease progression or unacceptable toxicity. Patients undergo MRI and blood sample collection and may optionally undergo cerebrospinal fluid collection throughout the study.

Primary Outcome Measure

Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ATM Kinase Inhibitor AZD1390 (AZD1390) for pediatric supratentorial high-grade gliomas [ Time Frame: Up to 75 days ]

Locations (20)

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