HSV G207 With a Single Radiation Dose in Children With Recurrent High-Grade Glioma

Withdrawn before enrolling · Phase 2

Conditions studied: Neoplasms, High Grade Glioma, Glioblastoma Multiforme, Malignant Glioma of Brain, Anaplastic Astrocytoma of Brain, High-grade Glioma, Anaplastic Glioma, Giant Cell Glioblastoma

In brief

This study is a clinical trial to assess the efficacy and confirm the safety of intratumoral inoculation of G207 (an experimental virus therapy) combined with a single 5 Gy dose of radiation in recurrent/progressive pediatric high-grade gliomas

Key facts

Study ID

NCT04482933

Run by

Pediatric Brain Tumor Consortium

People needed

0

Starts

2025-09-01

Expected to finish

2025-12-18

Last updated by the study team

2026-02-10

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant women are excluded from this study. Female patients of childbearing potential must have a negative serum or urine pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Pregnant women are excluded from this study because G207 is an agent with the potential for teratogenic or abortifacient effects.
• Lactating females are not eligible unless they have agreed not to breastfeed their infants. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with G207, breastfeeding should be discontinued if the mother is treated with G207.
• Concurrent Illness
• Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to undergo surgery and/or tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.
• Known HIV seropositivity.
• Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen for this trial.
• Patients with a secondary high-grade glioma are ineligible.
• Patient with primary tumor involving the cerebellum, brainstem or spinal cord or that would require surgical access through a ventricle in order to deliver the prescribed protocol treatment.
• Metastatic disease or diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain
• Tumor with evidence of clinically significant uncal herniation or midline shift, or evidence of ventricular obstruction from tumor or tonsillar herniation
• Diagnosis of encephalitis or CNS infection < 3 months prior, or receiving ongoing treatment for encephalitis, CNS infection, or multiple sclerosis
• Concomitant Medications
• Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.
• Patients who are receiving ≥ 1.5 mg of dexamethasone (or ≥ 10 mg of prednisone) daily
• Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir)
• Patients may not be on immunosuppressive therapy, including corticosteroids (except for patients receiving < 1.5 mg of dexamethasone or < 10 mg of prednisone daily) at time of enrollment. However, patients who require intermittent use of bronchodilators or topical steroids will not be excluded from the study.
• Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions.
• Prior Cranial Spinal Irradiation: Patients who received cranial spinal irradiation (CSI) are ineligible.

Where it is running

• Holly Lindsay MD — Aurora, Colorado, United States
• Memorial Sloan Kettering — New York, New York, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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