Actively Recruiting
Phase 1 Trial of Engineered HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
Led by M.D. Anderson Cancer Center · Updated on 2026-05-15
24
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
C
Cannonball Kids' Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety of G207, an experimental virus therapy, for children and young adults aged 3 to 21 years with recurrent or progressive cerebellar brain tumors. This phase 1 clinical trial evaluates G207 alone or combined with a low dose of radiation to enhance virus replication, tumor cell killing, and stimulate an anti-tumor immune response. The study aims to find safe treatment options for patients with poor outcomes after standard therapies have failed. Participants receive a single dose of G207 infused directly into tumor regions via catheters. If the first group tolerates G207 alone, subsequent groups will receive G207 followed by a 5 Gy radiation dose to tumor areas within 24 hours to potentially increase treatment effects. The study uses a 3 + 3 design with four patient groups to gradually test increasing doses and combinations. During the study, participants are monitored for safety by tracking adverse events and treatment effects. Researchers will also assess immune response, viral shedding, tumor progression, survival, daily functioning, and optional quality of life up to several years after treatment. The total monitoring period ranges from months to 15 years, ensuring long-term safety and effectiveness data collection.
CONDITIONS
Brief Title
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 years or older and under 22 years
- Diagnosed malignant cerebellar brain tumor that is progressive or recurrent despite standard care
- Tumor lesion between 1.0 cm and 3.0 cm in diameter and accessible for surgery
- Fully recovered from acute toxicities of prior chemotherapy, immunotherapy, or radiotherapy
- Last dose of myelosuppressive chemotherapy at least 3 weeks prior (6 weeks if nitrosurea)
- Last dose of investigational or biologic agents at least 7 days prior, with viral therapy at least 3 months prior
- Last dose of monoclonal antibodies at least 21 days prior
- Last craniospinal radiation or total body irradiation at least 3 months prior
- Last focal or palliative radiation at least 28 days prior
- At least 3 months since autologous bone marrow transplant
- Normal blood counts and organ function according to specified lab values
- Performance score of 60 or higher (Modified Lansky or Karnofsky)
- Life expectancy of at least 8 weeks
- Written informed consent obtained
You will not qualify if you...
- Treatment outside the allowed guidelines
- Widespread tumor involvement in 3 or more brain lobes
- Acute infection, granulocytopenia, or any condition preventing surgery
- Pregnant or breastfeeding females
- Recent or ongoing encephalitis, CNS infection, or multiple sclerosis treatment
- Tumor requiring ventricular or brainstem inoculation or access through ventricle
- Steroid increase within 1 week before G207 or requirement of more than 2 mg dexamethasone daily
- Known HIV positive status
- Concurrent use of drugs active against HSV or immunosuppressive drugs (except dexamethasone or prednisone)
- Other current malignancy
- Concurrent anticancer or investigational drug therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single treatment visit with follow-up assessments
Participants receive a single dose of G207 infused through catheters into the tumor region. Some participants may also receive a 5 Gy dose of radiation to the tumor within 24 hours of virus inoculation, depending on the cohort.
1 treatment visit (in-person) followed by additional visits for monitoring
Duration - Up to 60 months
Participants are monitored for safety, immune response, tumor progression, and overall health after treatment.
Multiple follow-up visits over 5 years
Trial Site Locations
Total: 3 locations
1
Children's of Alabama
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
Active, Not Recruiting
3
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Kara Kachurak, CRNP
G
Gregory K Friedman, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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