G207 for Children with Recurrent Cerebellar Brain Tumors
This study is testing a new treatment called G207, which is an experimental virus therapy, for children aged 3 to 21 years old with cerebellar brain tumors that have come back or are not responding to standard treatments. G207 is designed to specifically infect and kill cancer cells. The study will first check the safety of G207 given directly into the tumor. If it's safe, later participants will also receive a low dose of radiation after G207 to potentially make the treatment work even better. The main goal is to see how safe G207 is by tracking any serious side effects over a long period. The current status of this study is unclear.
- Study design
- This is an interventional study planning to enroll 24 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive a single dose of G207 infused into the tumor. Some participants may also receive a single dose of radiation.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and tolerability will be measured from the start of the study up to 15 years.
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NCT03911388
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
Recruiting
PHASE1Ages 36–22InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~24 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:G207
At a glance
Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events
Measured over Baseline to 15 years
Conditions
Where it's being run
3 sites across 3 statesAlabama1
Missouri1
Texas1
Study leadership
- Gregory Friedman, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse EventsBaseline to 15 years
All events with a Grade 3 or above toxicity (defined by the CTCAE v5.0) will be tabulated by event and by relationship to G207.