About this trial
This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested.
Funding Source- FDA OOPD
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
G207
Biological/VaccineSingle dose of G207 infused through catheters into region(s) of tumor. If G207 is safe in the first cohort of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor followed by a 5 Gy dose of radiation to the tumor (which includes progressive leptomeningeal disease or any site of gross tumor progressing in the brain parenchyma) within 24 hours of virus inoculation.
Treatment groups
Trial outcomes
Primary outcomes
Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events
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.
Secondary outcomes
Immunologic Response
HSV-1 antibody titers will be checked by ELISA prior to the administration of G207 and at regular intervals after treatment.
Virologic Shedding
HSV-1 antibody titers will be checked by ELISA prior to the administration of G207 and at regular intervals after treatment.
Progression Free Survival
Time after G207 administration to clinical and radiographic disease progression will be evaluated.
Overall Survival
The overall survival for each patient receiving G207 will be calculated
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
Cannonball Kids' Cancer Foundation
Collaborator
Treovir, Inc
Collaborator