Killer virus turned against childhood brain cancer
NCT ID NCT03911388
First seen Jun 25, 2026 · Last updated Sep 04, 2026 · Updated 6 times
Summary
This early-stage trial tests whether a specially engineered herpes virus (G207) is safe to inject directly into the brain tumors of children whose cancer has returned. Up to 24 children aged 3 to 21 will receive the virus, and some will also get a small dose of radiation to help the virus work better. The goal is to see if the treatment is safe enough to study further.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered herpes simplex virus (G207) with or without low-dose radiation
- What this could lead to
- If this works, it could point toward a new treatment option for children with hard-to-treat brain tumors that have come back after standard therapy.
- What could go wrong
- This is a very early (phase 1) safety trial with only 24 children, so it is not yet known if the virus helps shrink tumors. The virus may cause serious side effects, and combining it with radiation adds unknown risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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36 months to 22 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Siteman Cancer Center at Washington University
RECRUITINGSt Louis, Missouri, 63110, United States
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University of Alabama at Birmingham Cancer Center
RECRUITINGBirmingham, Alabama, 35233, United States
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Other studies related to the condition(s) this trial covers.
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