HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age36-22
SponsorM.D. Anderson Cancer Center

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

Qualifiers

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

Treatments tested in this trial

  • G207

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

Cannonball Kids' Cancer Foundation

Collaborator

Treovir, Inc

Collaborator