HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Summary

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

Conditions

• Neoplasms, 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

Interventions

BIOLOGICAL

G207

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.

Sponsors & Collaborators

• Cannonball Kids' Cancer Foundation

  collaborator OTHER

• Treovir, Inc

  collaborator UNKNOWN

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Gregory Friedman, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

3 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-12

Primary Completion

2026-09-01

Completion

2027-09-01

FDA Drug

Yes

Countries

• United States

Study Locations