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Virus Therapy
G207 + Radiation for Pediatric Brain Tumor
Phase 2
Waitlist Available
Led By Gregory Friedman, MD
Research Sponsored by Pediatric Brain Tumor Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Lesion must be ≥ 1.0 cm in longest dimension and surgically accessible as determined by contrast-enhanced MRI.
Performance score ≥ 60% (Karnofsky for children ≥16 years old; modified Lansky for children < 16 years old).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 15 years
Awards & highlights
Study Summary
This trial is testing a virus therapy combined with radiation to treat pediatric brain tumors.
Who is the study for?
This trial is for children and young adults aged 3 to less than 22 with recurrent high-grade gliomas, who've had prior surgery and radiotherapy. They must have stable neurological deficits, if any, and adequate organ/marrow function. Those on a steady or decreasing dose of dexamethasone are eligible. Patients cannot join if they have HIV, cerebellum/brainstem/spinal cord tumors requiring ventricular access, widespread brain involvement, recent CNS infections or encephalitis, ongoing anti-cancer treatments other than the study's protocol.Check my eligibility
What is being tested?
The trial tests G207 (an experimental virus therapy) combined with a single radiation dose in pediatric patients with recurring brain tumors called high-grade gliomas. The aim is to see how effective this combination is at treating these tumors and confirm its safety.See study design
What are the potential side effects?
Potential side effects may include typical reactions related to virus therapies such as flu-like symptoms (fever, chills), injection site pain or swelling, headache and fatigue. Radiation might cause skin irritation at the treatment site or temporary hair loss.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is at least 1.0 cm big and can be removed by surgery.
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I can care for myself and do most daily activities.
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My condition worsened for the first time after surgery and radiation.
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I've had surgery and radiotherapy for my condition and have recovered from major side effects.
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I was diagnosed after turning 3 and am currently younger than 22.
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My high-grade brain tumor is confirmed by a biopsy and is getting worse.
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I haven't taken any growth factor medications for at least 1 week.
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My surgeon believes my tumor can be reduced to 4.0 cm or less.
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
Efficacy (overall survival)
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Virologic Shedding
Other outcome measures
Change in Performance (Ability to Perform Normal Activities)
Correlate Radiographic Changes to G207 + 5 Gy Radiation
Immunologic Response: Expression Levels of Peripheral Blood Immune Cells, Cytokines, and Chemokines
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: HSV G207Experimental Treatment1 Intervention
All subjects will receive G207 at 1 x 10^8 plaque-forming units (pfu), intratumorally via controlled rate infusion through up to 4 silastic catheters over a 6 hour period. The subject will then receive a single 5 Gy dose of radiation to the tumor within 24 hours of virus inoculation.
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Who is running the clinical trial?
Pediatric Brain Tumor ConsortiumLead Sponsor
37 Previous Clinical Trials
1,542 Total Patients Enrolled
American Lebanese Syrian Associated Charities (ALSAC)UNKNOWN
8 Previous Clinical Trials
645 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,113 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin level is at least 8 g/dL, transfusions are okay.I am not taking any medication for herpes.I can have a catheter placed in all areas of my cancer on the same side.My neurological condition has been stable for at least a week.I received a cell-based therapy, like CAR T, over 3 months ago.My tumor size was measured in a specific way using MRI images.My tumor is at least 1.0 cm big and can be removed by surgery.I do not have any serious illnesses that would make surgery or treatment risky for me.My platelet count is above 100 without transfusions in the last week.I am not on strong immunosuppressive drugs, except for low doses of certain steroids.I have been on a stable or decreasing dose of dexamethasone for at least a week.My primary tumor is in my cerebellum, brainstem, spinal cord, or needs surgery through a ventricle.I can care for myself and do most daily activities.My condition worsened for the first time after surgery and radiation.I've had surgery and radiotherapy for my condition and have recovered from major side effects.I received my last dose of a monoclonal antibody treatment more than 7 days ago.I do not have HIV, confirmed by tests.My kidney function is within the required range for my age and gender, or tests show my kidneys filter at least 70 mL/min.I am not currently taking any cancer treatment or experimental drugs.I've recovered from side effects of any previous experimental treatments and it's been over a week since my last dose, or over 3 months for viral or cellular therapies.I am HIV positive.My cancer has spread to other parts of my body or affects 3 or more lobes of my brain.I was diagnosed after turning 3 and am currently younger than 22.I have not had radiation therapy to my brain and spine.I am taking more than 1.5 mg of dexamethasone or 10 mg of prednisone daily.I finished my radiation treatment of at least 54 Gy over 3 months ago, or had palliative radiation over 28 days ago.I had a stem cell transplant more than 6 months ago with no active graft vs. host disease or an autologous transplant more than 3 months ago.My high-grade brain tumor is confirmed by a biopsy and is getting worse.My tumor is causing significant brain pressure or blockage.I do not have a high-grade secondary brain tumor.I was diagnosed with or am being treated for encephalitis, a CNS infection, or multiple sclerosis recently.I received my last cancer treatment affecting my bone marrow 21 days ago, or 42 days ago if it was a specific type called nitrosourea.My organs and bone marrow are working well.I haven't taken any growth factor medications for at least 1 week.I don't have another cancer that could affect this trial's safety or results.You can participate in the study if your seizures are well managed and under control.My surgeon believes my tumor can be reduced to 4.0 cm or less.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: 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.
Are we still enrolling people for this experiment?
"As of now, this clinical trial is not looking for any more patients. According to the information found on clinicaltrials.gov, this study was first posted on December 1st, 2022 and was last updated on June 1st, 2022. Even though this study isn't enrolling patients at the moment, there are 3132 other studies that are still trying to recruit participants."
Answered by AI
How does Biological G207 affect patients negatively?
"While Phase 2 trials don't have any data supporting efficacy, there is some evidence that Biological G207 is safe. We've given it a score of 2."
Answered by AI
Who would be an appropriate candidate for this research program?
"This study is looking for 30 participants that meet the following criteria: They must be between 3 and 21 years old, have cancer, and have a performance score of 60% or higher (Karnofsky for children 16 years or older; modified Lansky for children under 16 years old). Additionally, patients must not have any neurological deficits that would prevent them from participating in the trial. A baseline detailed neurological exam should be conducted to determine eligibility. Patients with multifocal disease on one side are eligible if at least one catheter can be placed in all multifocal areas. Lastly, prior therapy should not include any investigational/bi"
Answered by AI
Are researchers looking for test subjects who are over the age of 30?
"This particular trial is designed for children aged 3 to 21. Out of the nearly 4000 active clinical trials, 425 are specific to minors and 2846 are geared towards senior citizens."
Answered by AI
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