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Virus Therapy

G207 for Brain Cancer

Phase 1
Waitlist Available
Led By Gregory Friedman, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiation: Patients must have received their last fraction of craniospinal radiation (>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.
Normal hematological, renal and liver function (absolute neutrophil count > 1000/mm3, platelets > 100,000/mm3, prothrombin time (PT) or partial thromboplastin time (PTT) < 1.3 x control, creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin < 1.5 mg/dl, transaminases < 3 times above the upper limits of the institutional norm)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 15 years
Awards & highlights

Study Summary

This trial is testing the safety of a new virus therapy, G207, for brain tumors. The therapy will be combined with a low dose of radiation.

Who is the study for?
This trial is for children and young adults aged 3 to less than 22 years with certain types of malignant cerebellar brain tumors that have returned or haven't responded to treatment. Participants must have stable vital functions, a specific performance score indicating they can perform daily activities, and a life expectancy of at least 8 weeks. They should not be on certain medications, have HIV, other cancers, or severe infections.Check my eligibility
What is being tested?
The study tests the safety of G207, an experimental virus therapy injected into recurrent or refractory cerebellar brain tumors. It also examines the effects when combined with low-dose radiation intended to boost virus replication and strengthen immune response against tumor cells.See study design
What are the potential side effects?
While specific side effects are not listed here, similar therapies may include flu-like symptoms (fever, chills), headache, nausea, fatigue due to immune system activation; localized pain from injection; potential risk of encephalitis (brain inflammation) if the virus affects healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had my last radiation treatment for the brain or whole body over 3 months ago, or for specific areas over 28 days ago.
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My blood, kidney, and liver tests are within normal ranges.
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I am between 3 and 21 years old.
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My cerebellar brain tumor is aggressive and has not responded to standard treatments.
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I am under 16 with a Lansky score over 60, or 16 and older with a Karnofsky score over 60.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events
Secondary outcome measures
Change in Performance (Ability to Perform Normal Activities)
Immunologic Response
Overall Survival
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: HSV G207Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
G207
2016
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Cannonball Kids' Cancer FoundationOTHER
5 Previous Clinical Trials
133 Total Patients Enrolled
1 Trials studying Neoplasms
13 Patients Enrolled for Neoplasms
Food and Drug Administration (FDA)FED
171 Previous Clinical Trials
1,331,582 Total Patients Enrolled
2 Trials studying Neoplasms
64 Patients Enrolled for Neoplasms
University of Alabama at BirminghamLead Sponsor
1,581 Previous Clinical Trials
2,278,005 Total Patients Enrolled
13 Trials studying Neoplasms
3,519 Patients Enrolled for Neoplasms

Media Library

G207 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03911388 — Phase 1
Neoplasms Research Study Groups: HSV G207
Neoplasms Clinical Trial 2023: G207 Highlights & Side Effects. Trial Name: NCT03911388 — Phase 1
G207 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03911388 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available slots for participation in this investigation?

"Affirmative. According to clinicaltrials.gov, this medical study which was initially posted on September 12th 2019 is seeking out 15 participants from one site as of July 28th 2022."

Answered by AI

Could octogenarians potentially partake in this medical experiment?

"The qualifications for this research require that participants are between 3 and 18 years of age. In total, there are 687 studies conducted with patients in the specified age group while 4229 trials were completed with individuals over 65."

Answered by AI

What criteria must be met for individuals to qualify as candidates in this research?

"This clinical trial is accepting 15 people with astrocytoma aged between 3 and 18 years old. To be eligible, applicants must meet certain criteria such as having pathologically proven malignant cerebellar brain tumor (including medulloblastoma, glioblastoma multiforme, giant cell glioblastoma etc.) which has progressed or recurred despite standard care including surgery, radiotherapy and/or chemotherapy; age greater than 36 months but less than 19 years; lesion size of 1.0 cm to a maximum of 3.0 cm in diameter that can be accessed surgically by MRI; fully recovered"

Answered by AI

What is the magnitude of participants involved in this research endeavor?

"Affirmative. Per the information provided on clinicaltrials.gov, this medical trial is presently recruiting participants, beginning from September 12th 2019 and most recently updated on July 28th 2022. A total of 15 patients are sought for enrollment by one site."

Answered by AI

Has the FDA given approval for G207 to be used therapeutically?

"The data collected on G207's safety and efficacy is limited, thus Power assigned a score of 1."

Answered by AI

Who else is applying?

What site did they apply to?
Children's of Alabama
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
Gregory K. Friedman, MD 2019. "HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03911388.
All > Autonomic Dysfunction > Anaplastic Astrocytoma
~5 spots leftby Sep 2025
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