What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as oncolytic virus therapy combined with radiation, have several known side effects. Oncolytic virus therapy can cause flu-like symptoms, including fever, chills, and fatigue, as well as local inflammation at the injection site. Radiation therapy, which causes DNA damage to cancer cells, can lead to side effects such as fatigue, skin changes, and hair loss in the treated area. More severe side effects may include neurocognitive decline, particularly in younger patients, and an increased risk of secondary cancers. Combining these therapies may amplify some of these effects, necessitating careful monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, primarily focusing on chemotherapy and radiation. Temozolomide, an oral alkylating agent, is commonly used in combination with radiotherapy for glioblastoma multiforme (GBM). Bevacizumab, an anti-angiogenic drug, has also been approved for recurrent GBM. While oncolytic virus therapies like G207 are still largely experimental, they represent a novel approach by using genetically engineered viruses to target and destroy cancer cells, often in combination with radiation to enhance DNA damage and tumor cell death.

What other types of research exist?

Promising novel alternatives to G207 combined with radiation for brain tumor patients include: 1) G47Δ, another oncolytic herpes simplex virus type 1, which has shown efficacy in phase I/II and phase II trials for recurrent glioblastoma. 2) Immune checkpoint inhibitors like pembrolizumab and nivolumab, which have shown potential in combination with other therapies. 3) IDH-targeted therapies such as ivosidenib and vorasidenib, particularly for IDH-mutant gliomas. 4) Bevacizumab, an anti-angiogenic therapy, which has been used in combination with other treatments for recurrent gliomas.

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Virus Therapy

G207 + Radiation for Pediatric Brain Tumor

Q: What is the mechanism of action of this treatment?

Oncolytic virus therapy and radiation therapy are promising treatments for brain tumors. Oncolytic viruses selectively infect and destroy cancer cells while activating the immune system to target the tumor. Radiation therapy uses high-energy radiation to cause DNA damage in cancer cells, leading to their death. Combining these therapies can enhance their effectiveness, offering a dual approach of direct tumor cell destruction and immune system activation, which is crucial for improving outcomes in brain tumor patients.

Phase 2

Recruiting

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).

Must not have

Concurrent therapy with any drug active against HSV (acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, cidofovir).

Patient with primary tumor involving the cerebellum, brainstem or spinal cord or that would require surgical access through a ventricle in order to deliver the prescribed protocol treatment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for children with aggressive brain tumors that haven't responded to other treatments. The treatment uses a special virus injected into the tumor, followed by a small dose of radiation. The virus kills cancer cells and helps the immune system fight the tumor.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medication for herpes.

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My primary tumor is in my cerebellum, brainstem, spinal cord, or needs surgery through a ventricle.

Select...

I do not have HIV, confirmed by tests.

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I am not currently taking any cancer treatment or experimental drugs.

Select...

I am HIV positive.

Select...

My cancer has spread to other parts of my body or affects 3 or more lobes of my brain.

Select...

I have not had radiation therapy to my brain and spine.

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I am taking more than 1.5 mg of dexamethasone or 10 mg of prednisone daily.

Select...

My tumor is causing significant brain pressure or blockage.

Select...

I do not have a high-grade secondary brain tumor.

Select...

I was diagnosed with or am being treated for encephalitis, a CNS infection, or multiple sclerosis recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Efficacy (overall survival)

Secondary study objectives

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Virologic Shedding

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oncolytic virus therapy and radiation therapy are promising treatments for brain tumors. Oncolytic viruses selectively infect and destroy cancer cells while activating the immune system to target the tumor. Radiation therapy uses high-energy radiation to cause DNA damage in cancer cells, leading to their death. Combining these therapies can enhance their effectiveness, offering a dual approach of direct tumor cell destruction and immune system activation, which is crucial for improving outcomes in brain tumor patients.