Clinical trial · Interventional
HSV G207 Alone or With a Single Radiation Dose in Children With Progressive or Recurrent Supratentorial Brain Tumors
Phase I Clinical Trial of HSV G207 Alone or With a Single Radiation Dose in Children With Recurrent Supratentorial Brain Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a clinical trial to determine the safety of injecting G207 (a new experimental virus therapy) into a recurrent or progressive brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication and tumor cell killing, will also be tested.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Cerebral Primitive Neuroectodermal Tumor | Cerebral Embryonal Tumor, Not Otherwise Specified | ALIAS | 0.90 |
| Embryonal Tumor | Embryonal Neoplasm | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Malignant Glioma | Malignant Glioma | ONTOLOGY_EXACT | 0.98 |
| PNET | Primitive Neuroectodermal Tumor | ALIAS | 0.90 |
| Supratentorial Neoplasms, Malignant | Malignant Supratentorial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G207 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HSV G207
- description
- Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor defined by MRI. If G207 is safe in the first two cohorts of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor defined by MRI followed by a 5 Gy dose of radiation to the tumor given with 24 hours of virus inoculation. Intervention: Biological: G207
- interventionNames
- Biological: G207
Primary outcomes (1)
- measure
- Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events
- timeFrame
- Baseline to 15 years
- description
- All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to G207.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 36 months and \< 19 years * Pathologically proven malignant supratentorial brain tumor (including 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 tumor without curative treatment options is eligible. * Lesion must be \> 1.0 cm in diameter and surgically accessible as determined by MRI * Patients must have fully recovered from acute treatment related toxicities of all prior chemotherapy, immunotherapy or radiotherapy prior to entering this study. * Myelosuppressive chemotherapy: patients must have received their last dose at least 3 weeks prior (or at least 6 weeks if nitrosurea) * Investigational/Biologic agents: patients must have recovered from any acute toxicities potentially related to the agent and received last dose ≥ 7 days prior to entering this study (this period must be extended beyond the time during which adverse events are known to occur for agents with known adverse events ≥ 7 days). For viral therapy, patients must have received viral therapy ≥ 3 months prior to study entry and have recovered from all acute toxicities potentially related to the agent * Monoclonal antibodies: patient must have received last dose ≥ 21 days prior * Radiation: Patients must have received their last fraction of craniospinal radiation (\>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation \> 28 days prior to study entry. * Autologous bone marrow transplant: Patients must be ≥ 3 months since transplant prior to study entry. * Normal hematological, renal and liver function (Absolute neutrophil count \> 1000/mm3, Platelets \> 100,000/mm3, Prothrombin Time (PT) or Partial Thromboplastin Time (PTT) \< 1.3 x control, Creatinine within normal institutional limits OR \> 60 mL/min/1.73 m2 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 \< 10 years, Modified Lansky score ≥ 60; patients \> 10 years, Karnofsky score ≥ 60 * Patient life expectancy must be at least 8 weeks * Written informed consent in accordance with institutional and FDA guidelines must be obtained from patient or legal guardian Exclusion Criteria: * Acute infection, granulocytopenia or medical condition precluding surgery * Pregnant or lactating females * Prior history of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection * Tumor involvement which would require ventricular, cerebellar or brainstem inoculation or would require access through a ventricle in order to deliver treatment * Required steroid increase within 1 week prior to injection * Known HIV seropositivity * Concurrent therapy with any drug active against HSV (acyclovir, valaciclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone).
References
Publications (1)
- DERIVEDFriedman GK, Johnston JM, Bag AK, Bernstock JD, Li R, Aban I, Kachurak K, Nan L, Kang KD, Totsch S, Schlappi C, Martin AM, Pastakia D, McNall-Knapp R, Farouk Sait S, Khakoo Y, Karajannis MA, Woodling K, Palmer JD, Osorio DS, Leonard J, Abdelbaki MS, Madan-Swain A, Atkinson TP, Whitley RJ, Fiveash JB, Markert JM, Gillespie GY. Oncolytic HSV-1 G207 Immunovirotherapy for Pediatric High-Grade Gliomas. N Engl J Med. 2021 Apr 29;384(17):1613-1622. doi: 10.1056/NEJMoa2024947. Epub 2021 Apr 10. PMID 33838625