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Virus Therapy

G207 for Brain Cancer

Phase 1

Waitlist Available

Led By Gregory Friedman, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radiation: Patients must have received their last fraction of craniospinal radiation (>24 Gy) or total body irradiation ≥ 3 months prior to study entry. Patients must have received focal radiation to symptomatic metastatic sites or local palliative radiation ≥ 28 days prior to study entry.

Normal hematological, renal and liver function (absolute neutrophil count > 1000/mm3, platelets > 100,000/mm3, prothrombin time (PT) or partial thromboplastin time (PTT) < 1.3 x control, creatinine within normal institutional limits OR creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, total bilirubin < 1.5 mg/dl, transaminases < 3 times above the upper limits of the institutional norm)

Must not have

Tumor involvement which would require ventricular or brainstem inoculation or would require access through a ventricle in order to deliver treatment

Other current malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety of a new virus therapy, G207, for brain tumors. The therapy will be combined with a low dose of radiation.

Who is the study for?

This trial is for children and young adults aged 3 to less than 22 years with certain types of malignant cerebellar brain tumors that have returned or haven't responded to treatment. Participants must have stable vital functions, a specific performance score indicating they can perform daily activities, and a life expectancy of at least 8 weeks. They should not be on certain medications, have HIV, other cancers, or severe infections.

What is being tested?

The study tests the safety of G207, an experimental virus therapy injected into recurrent or refractory cerebellar brain tumors. It also examines the effects when combined with low-dose radiation intended to boost virus replication and strengthen immune response against tumor cells.

What are the potential side effects?

While specific side effects are not listed here, similar therapies may include flu-like symptoms (fever, chills), headache, nausea, fatigue due to immune system activation; localized pain from injection; potential risk of encephalitis (brain inflammation) if the virus affects healthy brain tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had my last radiation treatment for the brain or whole body over 3 months ago, or for specific areas over 28 days ago.

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My blood, kidney, and liver tests are within normal ranges.

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I am between 3 and 21 years old.

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My cerebellar brain tumor is aggressive and has not responded to standard treatments.

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I am under 16 with a Lansky score over 60, or 16 and older with a Karnofsky score over 60.

Exclusion Criteria

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

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My treatment needs to be delivered through the brain's ventricles due to tumor location.

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I do not have any other type of cancer.

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I needed more steroids or took more than 2 mg of dexamethasone daily before a specific treatment.

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I am not taking any other cancer treatments or experimental drugs.

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I am not currently taking medication for herpes or any drugs that weaken my immune system, except dexamethasone or prednisone.

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I am HIV positive.

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My brain tumor affects 3 or more lobes.

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I do not have any infections or conditions that would prevent me from having surgery.

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. If G207 is safe in the first cohort of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor followed by a 5 Gy dose of radiation to the tumor given with 24 hours of virus inoculation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

G207

2016

Completed Phase 1

~20

0 / 13Eligibility criteria met