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Virus Therapy
G207 + Radiation for Brain Cancer
Phase 1
Waitlist Available
Led By Gregory K Friedman, M.D.
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
Be younger than 65 years old
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 experimental virus therapy, G207, for brain tumors. It will also test the safety of combining G207 with a single low dose of radiation.
Who is the study for?
This trial is for children aged 3 to less than 19 with certain types of aggressive brain tumors that have grown or returned despite treatment. They must be healthy enough for surgery, have recovered from previous treatments, and not be on specific drugs that could interfere with the study.Check my eligibility
What is being tested?
The trial is testing G207, an experimental virus therapy injected into the tumor. It's also looking at whether a low dose of radiation can boost the effects of G207 in killing tumor cells.See study design
What are the potential side effects?
Potential side effects are not detailed here but may include typical risks associated with virus therapies such as flu-like symptoms, injection site reactions, and increased susceptibility to infections.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 15 years
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 moreTrial 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 defined by MRI. If G207 is safe in the first two cohorts of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor defined by MRI followed by a 5 Gy dose of radiation to the tumor given with 24 hours of virus inoculation.
Intervention: Biological: G207
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?
Jaxon's F.R.O.G. FoundationUNKNOWN
National Center for Advancing Translational Sciences of the National Institutes of HealthUNKNOWN
Sandcastle KidsUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe infection, low white blood cell count, or a medical condition that prevents you from having surgery.You have had encephalitis, multiple sclerosis, or any other infection in your brain or spinal cord.Your tumor needs a specific type of treatment.You needed to take more steroids within a week before the injection.You have been diagnosed with HIV.You are between 3 and 18 years old.You have a brain tumor that is getting worse or coming back even after regular treatment.The abnormal area in the body must be larger than 1.0 cm and able to be removed through surgery, as confirmed by MRI.You are currently taking medications for herpes or drugs that weaken your immune system.Your blood, kidney, and liver tests are normal.If you are younger than 10, your activity level should be at least 60 out of 100 according to the Lansky score. If you are 10 or older, your activity level should be at least 60 out of 100 according to the Karnofsky score.
Research Study Groups:
This trial has the following groups:- Group 1: HSV G207
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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