HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03911388
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • G207 — BIOLOGICAL
    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.

Study Details

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

Key Dates

Start date
Sep 12, 2019
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HSV G207
    Single dose of HSV-1 (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 given with 24 hours of virus inoculation.

Primary Outcome Measure

Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events [ Time Frame: Baseline to 15 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35233-
St. Louis Children's HospitalSt LouisMissouri63110-
MD Anderson Cancer CenterHoustonTexas77030
Kara Kachurak, CRNP
[email protected]
832-750-5661
Gregory Friedman, MD
[email protected]

Find similar trials in Birmingham, AL

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Children's of Alabama· Birmingham, ALSt. Louis Children's Hospital· St Louis, MOMD Anderson Cancer Center· Houston, TX

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