G207 + Radiation for Brain Tumor

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Overseen ByGregory Friedman, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for individuals with recurring or worsening high-grade glioma, a type of brain tumor. Researchers aim to determine the safety and effectiveness of using G207, an experimental therapy, in combination with radiation therapy. As an experimental trial, this combination of treatments remains under investigation. Individuals with a high-grade glioma that has returned or is worsening, and who are not currently on other significant medications, might be suitable candidates for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant medical advancements.

Is there any evidence suggesting that G207 combined with radiation therapy is likely to be safe for humans?

Research has shown that G207, a treatment tested for brain tumors, has been safe in past studies. Earlier research administered G207 directly into patients' brain tumors without causing serious side effects. No side effects emerged that would prevent doctors from increasing the dose. Studies involving adults with high-grade gliomas (an aggressive type of brain tumor) demonstrated that G207 was safe when combined with a single dose of radiation, indicating no harmful side effects at the tested doses.

Overall, evidence suggests that G207 is well-tolerated in humans when used with radiation therapy. Participants should discuss any concerns with their healthcare provider before joining a clinical trial.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for brain tumors, which often include surgery, chemotherapy, and traditional radiation therapy, G207 is a genetically modified virus designed to specifically target and kill tumor cells while sparing healthy ones. Researchers are excited about G207 because it uses this innovative mechanism to enhance the effects of radiation therapy, potentially increasing its effectiveness. By directly attacking cancer cells and potentially triggering an immune response against the tumor, G207 offers a novel approach that could improve outcomes for patients with brain tumors.

What evidence suggests that G207 combined with radiation might be an effective treatment for high-grade glioma?

Research has shown that using G207 with radiation may effectively treat high-grade glioma (HGG), a type of brain tumor. In a recent study, 11 out of 12 patients responded well to this treatment. Their survival rate was more than twice the usual rate for those with recurring HGG. Another study found that patients treated with this combination lived for a median of 12.2 months, compared to the historical median of 5.6 months for similar cases. In this trial, participants will receive the combination of G207 and 5 Gy radiation, which may significantly extend the lives of patients with this challenging condition.56789

Who Is on the Research Team?

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Gregory Friedman, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for children who have a high-grade glioma brain tumor that has come back or is getting worse. Participants must be able to safely receive both the study treatment and radiation.

Exclusion Criteria

Patients with clinically significant unrelated systemic illness compromising surgery or protocol therapy tolerance or interfering with study procedures or results
I am currently taking other cancer or experimental drugs.
I am not pregnant, as confirmed by a recent pregnancy test.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

G207 administered intratumorally followed by 5 Gy radiation within 24 hours

1 week
Inpatient treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • G207

Trial Overview

The study tests G207, an experimental virus-based therapy, given together with a low dose (5 Gy) of radiation. The goal is to see if this combination is safe and effective in treating these aggressive brain tumors.

How Is the Trial Designed?

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Treatment groups

Experimental Treatment

Group I: Treatment with G207 (IT) + 5 Gy RadiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

NCT04482933 | HSV G207 With a Single Radiation Dose ...

Outcomes for children with recurrent or progressive high-grade glioma (brain tumor) are very poor, and there are a lack of effective salvage therapies

Oncolytic HSV-1 G207 Immunovirotherapy for Pediatric ...

Survival rates have not improved in 30 years; the 3-year event-free survival among patients … is 11 to 22%.1,2 is only 5.6 months.2,3

Phase II Clinical Trial of G207 HSV To Treat Children ...

A recent meta-analysis (Kline et al., 2018) reported an average median survival of 5.6 months (95% CI=3.9-7.3) for 129 children with recurrent HGG in 17 ...

G207 + Radiation for Pediatric Brain Tumor

Outcomes in children and adolescents with recurrent or progressive high-grade glioma are poor, with a historical median overall survival of 5.6 months.

Published in NEJM, UAB study shows signs of clinical ...

In the current trial, 11 of the 12 patients demonstrated a treatment response. The overall survival rate was more than double the typical ...

Oncolytic HSV-1 G207 Immunovirotherapy for Pediatric High ...

Survival rates have not improved in 30 years; G207 was safe when inoculated intratumorally, into brain surrounding tumor

HSV G207 in Children With Recurrent or Refractory ...

Outcomes for children with recurrent or progressive cerebellar malignant brain tumors are very poor, and there are a lack of effective salvage ...

Oncolytic HSV-1 G207 immunovirotherapy for pediatric ...

G207 was safe when inoculated intra- tumorally, into brain surrounding tumor resec- tion cavities, and combined with a single radiation dose.14 ...

NCT03911388 | HSV G207 in Children With Recurrent or ...

The safety of G207 has been demonstrated in 3 phase I clinical trials involving adults with supratentorial high-grade gliomas adults at the University of ...