C134 for Brain Tumors
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot take any drugs active against HSV (a type of virus) or any other investigational agents. If you're on steroids, your dose should not increase within 2 weeks before starting the trial, and it should ideally be equivalent to 2mg of dexamethasone daily.
What data supports the effectiveness of the treatment IRS-1 HSV C134 for brain tumors?
Research on similar treatments, like the oncolytic herpes simplex virus G207, shows promise in targeting brain tumors by safely inducing an immune response and increasing survival in animal models. Additionally, another oncolytic virus, HSV1716, has been shown to inhibit tumor migration and invasion, suggesting potential effectiveness in treating brain tumors.12345
Is the treatment C134 for brain tumors safe for humans?
How does the treatment IRS-1 HSV C134 for brain tumors differ from other treatments?
The treatment IRS-1 HSV C134 is unique because it is a chimeric oncolytic virus that combines elements from two viruses to enhance its ability to replicate in and destroy tumor cells without harming normal brain cells. This approach improves tumor reduction and survival in brain tumor models compared to other similar treatments.27101112
What is the purpose of this trial?
The purpose of this study is to determine how safe and how well-tolerated the experimental study drug, C134 is when administered twice into the brain where the tumor is located. This is a Phase IB 2 dosing study. All the patients who take part in this study will receive the same type of experimental treatment. There is no "placebo" in this study. The patient will receive the dose of C134 administered, which will be added in the tumor infiltrated tissue in the area of the resection cavity. Anywhere from 4-12 patients are expected to take part in the study; the final number will depend on the safety results.
Eligibility Criteria
This trial is for a small group of 4-12 patients with recurrent malignant glioma, which includes specific brain tumors like glioblastoma and astrocytoma. Participants must have a tumor that can be reached to administer the treatment directly.Inclusion Criteria
Exclusion Criteria
Timeline
Initial Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment
Participants receive the first dose of the study drug C134 administered intratumorally
Initial Treatment Follow-up
Participants are monitored for safety and effectiveness after the initial treatment
2nd Treatment Screening
Participants are assessed for eligibility for the second dose of treatment
2nd Treatment
Participants receive the second dose of the study drug C134 if eligible
2nd Treatment Follow-up
Participants are monitored for safety and effectiveness after the second treatment
Long-term Follow-up
Participants are monitored for long-term safety and survival outcomes
Treatment Details
Interventions
- IRS-1 HSV C134
Find a Clinic Near You
Who Is Running the Clinical Trial?
James Markert, MD
Lead Sponsor