Targeted Pediatric High-Grade Glioma Therapy

Eligibility Criteria

• 1. Age: Patients must be ≥12 months and ≤30 years of age at the time of enrollment onto this screening protocol.
• 2. 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.
• 3. Disease Status: There are no disease status requirements for enrollment.
• * Measurable disease is not required. Patients without measurable disease are eligible.
• * Patients with metastatic/disseminated or multifocal disease or gliomatosis cerebri are eligible.
• * Patients with a primary spinal tumor are eligible.
• * Patients with secondary, radiation related HGG are eligible.
• 4. Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible. Temozolomide concurrent with radiation is permissible, but not recommended. No other prior anticancer therapy for HGG will be allowed.
• 5. Tumor Sample Availability OR results from previous molecular profiling/targeted sequencing
• * If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood or saliva) must be submitted for comprehensive molecular screening at the time of screening enrollment.
• * If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review.
• 6. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
• 7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT
• * Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT.
• * Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT.
• * For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT.
• * For treatment protocols that only include maintenance/adjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT
• * OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories
• * OPTION2: Molecular screening through a national comprehensive tumor profiling program
• * OPTION3: Clinically validated targeted sequencing or focused profiling