Using a virus therapy to treat recurrent cerebellar brain tumors in children
Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
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.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 3 Years to 21 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, Radiation, prednisone |
| Locations | 3 sites (Birmingham, Alabama and 2 other locations) |
| Trial ID | NCT03911388 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 36 months to 22 years with pathologically confirmed recurrent or progressive malignant cerebellar brain tumors.
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.
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 performed: Previous studies involving G207 in adults have shown promising safety results, but this specific application in children is novel.
Eligibility criteria
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. * Lesion must be ≥ 1.0 cm ≤ 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 * 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: The 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 creatinine clearance \>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 \< 16 years, Modified Lansky performance score ≥ 60; patients ≥ 16 years, Karnofsky performance 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: * Any treatment outside the allowable guidelines outlined in section 5.1. * Diffuse, widespread, abnormal tumor pattern involving 3 or more lobes of the brain * Acute infection, granulocytopenia or medical condition precluding surgery * Pregnant or lactating females * Diagnosis of encephalitis or CNS infection \< 3 months prior, or 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 * Required steroid increase within 1 week prior to G207 inoculation or patients requiring \>2 mg of dexamethasone daily * Known HIV seropositivity * Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, gancyclovir, foscarnet, cidofovir) or any immunosuppressive drug therapy (except dexamethasone or prednisone). * Other current malignancy * Concurrent anticancer or investigational drug
Where this trial is running
Birmingham, Alabama and 2 other locations
- Children's of Alabama — Birmingham, Alabama, United States (Active_not_recruiting)
- St. Louis Children's Hospital — St Louis, Missouri, United States (Active_not_recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Gregory Friedman, MD — M.D. Anderson Cancer Center
- Study coordinator: Kara Kachurak, CRNP
- Email: kgkachurak@mdanderson.org
- Phone: 832-750-5661l
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.