Genetically Engineered HSV-1 for Brain Cancer

(M032-HSV-1 Trial)

Recruiting in Palo Alto (17 mi)

Overseen by James Markert, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Alabama at Birmingham

No Placebo Group

Trial Summary

What is the purpose of this trial?

To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simplex Virus-1 in patients who would not be eligible for surgical resection of recurrent glioma To determine the safety and tolerability of the maximum dose for laboratory engineered Herpes Simples Virus-1 in patients who would benefit from surgical resection of recurrent glioma

Eligibility Criteria

Adults over 18 with certain types of brain tumors (glioblastoma, astrocytoma, gliosarcoma) that have recurred. They must have tried radiotherapy and chemotherapy already, be in good health otherwise, not pregnant or breastfeeding, willing to use contraception and avoid contact with vulnerable individuals post-treatment. Tumors should be a specific size and location for local treatment.

Inclusion Criteria

Agreement to use adequate contraception, avoid intimate contact with certain individuals, and refrain from blood donation during the trial

Ability to understand and sign a written informed consent document

I am a woman who can have children and I have a negative pregnancy test from the last 14 days.

Exclusion Criteria

I haven't had chemotherapy, immunotherapy, or surgery in the last 4 weeks.

I have a history of certain brain or nerve conditions.

I haven't needed more steroids, don't have an active oral herpes lesion, and am not on drugs for HSV.

Participant Groups

The trial is testing M032 (NSC 733972), a genetically engineered Herpes Simplex Virus-1 designed to treat recurrent malignant gliomas. It's given directly into the tumor site to see if it's safe at its highest dose and how well patients tolerate it.

Group I: Group A single dose of HSV-1 (M032) Experimental Treatment 1 Intervention

single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alabama at Birmingham Birmingham, AL

Who Is Running the Clinical Trial?

University of Alabama at Birmingham Lead Sponsor

National Cancer Institute (NCI) Collaborator

References