What side effects are associated with this type of intervention?

Common treatments for Primitive Neuroectodermal Tumor (PNET) include chemotherapy, radiation therapy, and surgical resection. Chemotherapy can cause side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection. Radiation therapy may lead to skin irritation, fatigue, and potential long-term effects such as cognitive changes and secondary cancers. Treatments similar to the G207 trial, which involve virus-mediated tumor cell killing enhanced by radiation, are still experimental. Potential side effects could include inflammation at the injection site, flu-like symptoms, and enhanced radiation side effects such as increased fatigue and localized tissue damage.

What prior FDA approvals exist?

Primitive Neuroectodermal Tumors (PNET) are typically treated with a combination of surgery, radiation, and chemotherapy. Common chemotherapeutic agents include vincristine, cyclophosphamide, and doxorubicin. While there are no specific FDA-approved virus-mediated therapies for PNET, the experimental treatment G207 involves using a genetically modified virus to target tumor cells, potentially enhanced by radiation. This approach is still under clinical investigation and represents a novel strategy compared to traditional treatments.

What other types of research exist?

Promising novel alternatives to G207 for Primitive Neuroectodermal Tumor patients include: 1) G47Δ, a triple-mutated oncolytic herpes simplex virus type 1, which has shown safety and potential efficacy in glioblastoma patients. 2) Immunotherapy approaches such as anti-GD2 CAR T cells, which have demonstrated potent antitumor efficacy in gliomas. 3) Dual endothelin receptor antagonists like macitentan, which have shown promising results in combination with temozolomide in glioblastoma models. These therapies are in various stages of clinical development and could offer new treatment options for PNET patients.

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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

No Placebo-Only Group

Summary

This trial tests a new treatment where a special virus is injected into brain tumors in children, sometimes followed by a small dose of radiation. The virus kills cancer cells and helps the immune system fight the tumor. This approach aims to find a safe and effective treatment for children with hard-to-treat brain tumors.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 15 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

Safety and Tolerability as Measured by Frequency of Grade 3 or Above Adverse Events

Secondary study objectives

Change in Performance (Ability to Perform Normal Activities)

Immunologic Response

Overall Survival

+3 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: 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

Do I qualify?Apply below to find out

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

The most common treatments for Primitive Neuroectodermal Tumor (PNET) include chemotherapy, radiation therapy, and emerging virus-mediated therapies. Chemotherapy works by using drugs to kill rapidly dividing cancer cells, while radiation therapy uses high-energy rays to target and destroy tumor cells. Virus-mediated therapies, such as the G207 trial, involve injecting a genetically engineered virus that selectively infects and kills tumor cells. This process can be enhanced by a low dose of radiation, which increases the virus's replication and tumor cell killing efficacy. These treatments are crucial for PNET patients as they offer targeted approaches to eliminate cancer cells, potentially improving survival rates and reducing damage to surrounding healthy tissues.

How do we approach the management of medulloblastoma in young children?Treatment strategies for medulloblastoma and primitive neuroectodermal tumors.