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Recruiting Phase 1 NCT06894979

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

Trial Parameters

Condition Childhood Astrocytoma
Sponsor Children's Oncology Group
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 54
Sex ALL
Min Age 12 Months
Max Age 22 Years
Start Date 2025-06-18
Completion 2028-03-31
Interventions
ATM Kinase Inhibitor AZD1390Biospecimen CollectionMagnetic Resonance Imaging

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * COHORT A and COHORT B: For the dose escalation phase, patients must be ≥ 12 months and \< 18 years of age at the time of study enrollment * COHORT C and COHORT D: For the disease expansion phase, patients must be ≥ 12 months and \< 22 years of age at the time of study enrollment * Patients with newly diagnosed primary high-grade glioma (HGG), diffuse midline glioma (DMG) (excluding primary spinal tumors), or diffuse intrinsic pontine glioma (DIPG) who are eligible to receive 54-59.4 grey (Gy) fractionated radiation at 1.8 Gy/day. Patients must have had histologic verification of malignancy at original diagnosis except in patients with DIPG as defined below. * COHORTS A AND C (SUPRATENTORIAL TUMORS): * HGG and non-pontine DMG: * Patients with newly diagnosed HGG (including diffuse hemispheric glioma, H3 G34-mutant; diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype; astrocytoma; IDH-mutant; or glioblastoma, IDH-wildtype): or non-pontine DMG (inc

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