G207 for Brain Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byGregory Friedman, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This study is a clinical trial to determine the safety of inoculating G207 (an experimental virus therapy) into a recurrent or refractory cerebellar brain tumor. The safety of combining G207 with a single low dose of radiation, designed to enhance virus replication, tumor cell killing, and an anti-tumor immune response, will also be tested. Funding Source- FDA OOPD

Research Team

Gregory Friedman, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I have recovered from side effects of my previous cancer treatments.

My tumor is between 1.0 and 3.0 cm in size and can be operated on.

I've recovered from side effects of previous treatments and it's been over a week since my last dose, or over 3 months if it was viral therapy.

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Exclusion Criteria

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

Pregnant or lactating females

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

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Treatment Details

Interventions

G207 (Virus Therapy)

Trial OverviewThe 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.

Participant Groups

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.