Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 36 Months to 22

Using a virus therapy to treat recurrent cerebellar brain tumors in children

Official title: Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Run by M.D. Anderson Cancer Center · NCT03911388 · Data updated 2026-11-12

This study is testing a new virus treatment for children with recurring brain tumors to see if it can help them get better when combined with a low dose of radiation.

More Neoplasms trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages36 Months to 22 Years
SexAll
Enrollment24 (estimated)
SponsorM.D. Anderson Cancer Center
Academic / other
Drugs / interventionschemotherapy, Immunotherapy, Radiation, prednisone
Locations3 sites (Birmingham, Alabama and 2 other locations)
StatusRecruiting
StartedSeptember 12, 2019
Main results expectedSeptember 1, 2026
Study endsSeptember 1, 2027
Registry record updatedSeptember 4, 2026
Trial IDNCT03911388 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 36 months to 22 years with pathologically confirmed recurrent or progressive malignant cerebellar brain tumors.

Probably not a fit

Patients with tumors that are not surgically accessible or those who have not fully recovered from previous treatments may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety of G207, an experimental oncolytic herpes simplex virus, when injected into recurrent or refractory cerebellar brain tumors in children. The study also investigates the effects of combining G207 with a low dose of radiation to enhance the virus's ability to replicate and kill tumor cells while stimulating an anti-tumor immune response. The trial aims to provide a new treatment option for children with poor outcomes from existing therapies. Participants will be closely monitored for safety and efficacy as the study progresses.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for children with aggressive brain tumors that have not responded to standard treatments.

How similar studies have gone: Previous studies involving G207 in adults have shown promising safety results, but this specific application in children is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥ 36 months and \< 22 years
* Pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma, anaplastic astrocytoma, primitive neuroectodermal tumor, ependymoma, atypical teratoid/rhabdoid tumor, germ cell tumor, or other high-grade malignant tumor) which is progressive or recurrent despite standard care including surgery, radiotherapy, and/or chemotherapy. A pathologically proven secondary malignant cerebellar tumor without curative treatment options is eligible.
* A review of the MRI scan will be necessary to determine if the tumor location and size are such that the patient may be included in the study. The MRI scan must be reviewed and approved by the site neurosurgeon and/or study radiologist for enrollment. The following guidelines must be met: Lesion must be ≤ 3.0 cm in diameter and surgically accessible as determined by MRI. Larger tumors may be surgically debulked and treated if ≤ 3.0 cm after debulking. Tumor measurements should be confirmed on the Immunotherapy Response Assessment in Neuro-Oncology (iRANO) form or the institutional MRI report
* Patients must have fully recovered from acute treatment-related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to the date of G207 administration. All washout intervals below are measured relative to the date of G207 administration.
* Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea) to G207 administration.
* Monoclonal antibodies: patient must have received the last dose ≥ 21 days prior to G207 administration
* Investigational/Biologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to G207 administration (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥\>= 7 days).
* Viral therapy: Patients must have received viral therapy ≥ 3 months prior to G207 administration and must have recovered from all acute toxicities potentially related to the agent
* Radiation: Patients must have received their last fraction of craniospinal radiation (\>24 Gy) or total body irradiation ≥ 3 months prior to G207 administration. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to G207 administration.
* Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to G207 administration.
* Absolute neutrophil count \> 1000/mm3
* Platelets ≥ 100,000/mm\^3
* Prothrombin time (PT) or partial thromboplastin time (PTT) ≤ 1.3 x control
* Creatinine within normal institutional limits OR creatinine clearance \>60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
* Total bilirubin ≤ 1.5 mg/dl
* Transaminases ≤ 3 times above the upper limits of the institutional norm
* Patients \< 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance score ≥ 60
* Written informed consent in accordance with institutional and Food and Drug Administration (FDA) guidelines must be obtained from patient or legal guardian

Exclusion Criteria:

* Acute infection, granulocytopenia or medical condition precluding surgery
* Pregnant or lactating females
* Diagnosis of encephalitis or central nervous system (CNS) infection ≤ 3 months prior
* Receiving ongoing treatment for encephalitis, CNS infection or multiple sclerosis
* Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment
* Patient requires an escalation in ongoing systemic corticosteroid therapy within 7 days prior to G207 inoculation or requires ongoing systemic corticosteroid therapy at a dose \> 2 mg/day of dexamethasone (or equivalent) at the time of inoculation. For this study, 'systemic corticosteroids' include oral, intravenous, or intramuscular formulations. A single, non-consecutive dose does not constitute exclusion. Physiologic corticosteroid replacement therapy (e.g., hydrocortisone for adrenal insufficiency) is not considered immunosuppressive and does not constitute exclusion
* Known human immunodeficiency virus (HIV) seropositivity
* Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone)
* 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
* Concurrent anticancer or investigational drug

Where it's running

  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama, United States
    Recruiting
  • Siteman Cancer Center at Washington University
    St Louis, Missouri, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.