C134 Re-Administration for Brain Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and tolerance of a drug called C134 when administered again to individuals with recurring brain tumors. The focus is on conditions like glioblastoma multiforme, an aggressive type of brain cancer. Suitable candidates for this trial include those who previously tried C134 in an earlier study and experienced tumor recurrence or growth. Participants should have undergone specific radiation treatments beforehand. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.
Do I need to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications, but you cannot be on any drugs active against HSV (a type of virus) or other investigational therapeutic agents. If you are on steroids, your dose should not increase within 2 weeks of the C134 administration.
Is there any evidence suggesting that C134 is likely to be safe for humans?
Research shows that C134, a specially designed virus, targets and destroys cancer cells without harming healthy ones. Studies have found that it can multiply and break down cancer cells in the brain, particularly where the tumor's defenses are weak. In earlier research, C134 was tested for safety in people with brain tumors. The results suggested it is generally well-tolerated, although the study primarily focused on understanding its side effects. While the treatment remains in early trials, this phase primarily assesses initial safety, so participants should be aware that the full range of effects is still under exploration.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for recurrent malignant glioma, which often include surgery, radiation, and chemotherapy, C134 is unique because it utilizes a genetically modified virus. This treatment is derived from the herpes simplex virus (HSV-1) but is engineered to specifically target and kill cancer cells while sparing healthy tissue. Researchers are excited about C134 because this targeted approach could potentially offer a more effective treatment with fewer side effects compared to conventional therapies. By harnessing the virus's natural ability to spread through and destroy tumor cells, C134 may provide a novel way to combat aggressive brain tumors like glioblastomas.
What evidence suggests that C134 might be an effective treatment for brain tumors?
Research has shown that C134, the investigational treatment in this trial, might help fight brain tumors, such as recurrent malignant glioma. Studies have found that C134 can strengthen the body's immune system to attack tumors, potentially helping the immune system shrink the tumor. Early results suggest that C134 is safe when injected directly into the brain tumor. These findings are promising, but more research is needed to confirm its effectiveness.15678
Who Is on the Research Team?
James Markert, MD
Principal Investigator
The University of Alabama at Birmingham
Are You a Good Fit for This Trial?
This trial is for individuals with recurrent glioblastoma or similar brain tumors. Participants should have a tumor that has returned after previous treatment and be in good enough health to receive the experimental therapy directly into their brain.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive re-administration of C134 intratumorally to assess safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- C134
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor