C134 Virus Therapy for Glioblastoma
(C134-HSV-1 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJames 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?The purpose of this project is to obtain safety information in small groups of individuals, scheduled to receive escalating doses of C134, a cancer killing virus (HSV-1) that has been genetically engineered to safely replicate and kill glioma tumor cells. Safety will be assessed at each dose level before proceeding to the next dose level. A special statistical technique called the Continual Reassessment Method (CRM) will be used to determine when higher doses of virus can be administered. Other objectives of the study include characterization of the activity of C134 after inoculation into the tumor and of the local and systemic immune responses to C134. Patients will also be followed with MRI scans for potential clinical response to C134. The clinical strategy takes advantage of the virus' ability to infect and kill tumor cells while making new virus within the tumors cells; a critical enhancement of this effect is accomplished by the induction of an anti-tumor immune response; both effects are produced by the IRS-1 gene that was placed into the virus by genetic engineering. An additional important component of the research are systematic assessments of the quality of life on treated patients.

Eligibility Criteria

This trial is for adults over 18 with recurrent brain tumors (glioblastoma, anaplastic astrocytoma, or gliosarcoma) who've had prior radiation therapy. They must have a life expectancy over 4 weeks and be in good health otherwise. Participants need to use birth control due to unknown effects on fetuses and agree not to join if they're pregnant, have increased their steroid dose recently, or are taking anti-HSV drugs.

Inclusion Criteria

My organ and bone marrow functions are normal.

My diagnosis is a type of aggressive brain tumor.

My previous brain radiotherapy was unsuccessful, and it was over 4 weeks ago.

+8 more

Exclusion Criteria

My cancer affects areas that need targeted treatment.

I am currently taking medication for herpes.

I do not have any uncontrolled illnesses.

+8 more

Participant Groups

The trial tests C134, a genetically modified herpes virus designed to target and kill tumor cells while boosting the immune response against the tumor. Patients will receive increasing doses of C134 directly into their tumors using MRI guidance. The study also monitors how the body reacts to the virus and any changes in tumor size via MRI scans.

1Treatment groups

Experimental Treatment

Group I: C134 TreatmentExperimental Treatment1 Intervention

All patients who enroll will receive C134 inoculation into their tumor (one time procedure with 1-5 inoculation sites)