Study on HSV G207 Virus Therapy with Radiation for Children with Recurrent High-Grade Brain Tumors

Sponsor: Pediatric Brain Tumor Consortium

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04482933

Provider View

This clinical trial is testing a new virus therapy called G207, combined with a small dose of radiation, to see if it can safely and effectively treat children with high-grade brain tumors that have returned or are growing after previous treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment for children with high-grade brain tumors that have come back or are not responding to standard treatments. The treatment uses a special virus, G207, which is designed to attack and kill cancer cells without harming normal cells. The virus is injected directly into the tumor, and a small dose of radiation is given to help the virus work better. The main goal is to see if this treatment can shrink the tumors and to confirm that it is safe for children.

Description

Children with high-grade brain tumors that have returned or are growing after standard treatments have limited options. This study is testing a new approach using a virus called G207, which is a modified herpes virus that targets and kills cancer cells. The virus is injected directly into the tumor, where it multiplies and destroys cancer cells, while also triggering the immune system to attack the tumor. A small dose of radiation is given to enhance the virus's effects.

Previous studies in adults have shown that this virus can be safely injected into brain tumors, and some patients have shown signs of tumor shrinkage. This study is now testing the treatment in children aged 3 to 18 with recurrent high-grade brain tumors. The treatment involves placing up to four small tubes into the tumor to deliver the virus over six hours, followed by a single dose of radiation within 24 hours.

The study aims to determine if this combination can effectively shrink tumors and to ensure it is safe for children. Participants will be closely monitored for any side effects and the treatment's impact on their tumors.

Eligibility Criteria

Inclusion Criteria

  • Children aged 3 to under 22 years at the time of joining the study.
  • Diagnosed with a high-grade brain tumor that has returned or is growing, confirmed by a biopsy.
  • Tumor must be at least 1 cm in size and accessible for surgery.
  • If the tumor is larger than 4 cm, it must be possible to reduce it to 4 cm or smaller through surgery.
  • Tumors on the same side of the brain can be treated if a tube can be placed in each area.
  • Must have a performance score of 60% or higher, indicating the ability to carry out daily activities.
  • Neurological symptoms must be stable for at least one week before joining the study.
  • Must have had previous surgery and radiation, and recovered from any side effects.
  • Last radiation treatment must have been at least three months ago.
  • Must have stopped chemotherapy at least 21 days before joining the study.
  • Must have adequate blood cell counts and organ function.
  • Must not be pregnant and agree to use birth control during the study.

Exclusion Criteria

  • Pregnant or breastfeeding women cannot participate.
  • Have any serious unrelated illnesses that could interfere with the study.
  • Have HIV or another cancer that could affect the study results.
  • Have a secondary high-grade brain tumor or a tumor in certain brain areas that are hard to reach.
  • Have widespread brain tumors or certain brain conditions like herniation.
  • Have had a brain infection or encephalitis within the last three months.
  • Currently receiving other cancer treatments or certain medications.
  • Unable to attend follow-up visits or comply with study requirements.
  • Have had cranial spinal irradiation.

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