HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

ConditionsNeoplasms, Brain Glioblastoma Multiforme Glioblastoma of Cerebellum Neoplasms Astrocytoma Astrocytoma, Cerebellar Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Cerebellar PNET, Childhood Cerebellar Neoplasms Cerebellar Neoplasms, Primary Cerebellar Neoplasm, Malignant Cerebellar Neoplasm Malignant Primary Neoplasm Metastases Neoplasm Malignant Neoplasms, Neuroepithelial Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms, Primary Central Nervous System Neoplasms, Malignant Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Medulloblastoma Recurrent HSV Virus Pediatric Brain Tumor Nervous System Cancer Primitive Neuroectodermal Tumor (PNET) of Cerebellum

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age3-21

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.

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.

Disqualifiers

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

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

Source ClinicalTrials.gov