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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • G207

    Biological/Vaccine

    Single 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

24 Participants
are divided into 1 treatment group
Group A: HSV G207Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to 15 years

Secondary outcomes

1

Immunologic Response

HSV-1 antibody titers will be checked by ELISA prior to the administration of G207 and at regular intervals after treatment.

Time frame
24 months
2

Virologic Shedding

HSV-1 antibody titers will be checked by ELISA prior to the administration of G207 and at regular intervals after treatment.

Time frame
Up to 15 years
3

Progression Free Survival

Time after G207 administration to clinical and radiographic disease progression will be evaluated.

Time frame
Up to 15 years
4

Overall Survival

The overall survival for each patient receiving G207 will be calculated

Time frame
Up to 15 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Cannonball Kids' Cancer Foundation

Collaborator

Treovir, Inc

Collaborator