Gene Therapy + Radiotherapy for Brain Tumor
Trial Summary
What is the purpose of this trial?
The primary goal of this Phase I study is to determine the maximum tolerated dose of oncolytic adenovirus mediated double suicide-gene therapy in combination with fractionated stereotactic radiosurgery in patients with recurrent high-grade astrocytoma undergoing resection.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have recovered from previous treatments and cannot be on immunosuppressive therapy, except for corticosteroids.
What data supports the effectiveness of the treatment Gene Therapy + Radiotherapy for Brain Tumor?
Is the gene therapy combined with radiotherapy safe for humans?
Research shows that the gene therapy using adenovirus (Ad5-CD/TKrep and Ad5-yCD/mutTKSR39rep-ADP) combined with radiotherapy has been tested in humans, particularly for prostate cancer, and has been found to be generally safe. Most side effects were mild or moderate, and no severe toxicities were reported, indicating that this treatment approach is safe for human use.13467
What makes the Gene Therapy + Radiotherapy treatment for brain tumors unique?
This treatment is unique because it combines a gene therapy using a modified adenovirus to deliver a fusion gene that makes tumor cells more sensitive to antiviral drugs and radiation, enhancing the effectiveness of radiotherapy. This approach, known as double suicide gene therapy, uses two enzyme/prodrug systems to increase tumor cell death and improve treatment outcomes compared to traditional therapies.12389
Research Team
Tobias Walbert, MD, PhD, MPH
Principal Investigator
Henry Ford Health System
Eligibility Criteria
Adults with recurrent high-grade astrocytoma eligible for tumor resection, not previously treated with certain gene/immunotherapies or implants. Must have good organ function, no immune disorders, and agree to birth control. Excludes those with serious illnesses that could interfere with the trial, pregnant/lactating women, allergy to protocol products, impaired immunity, inability to undergo MRI, acute infections or liver disease.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Adenovirus Injection
Patients undergo repeat surgery for tumor resection followed by intratumoral injection of modified oncolytic adenovirus
Treatment
Participants receive fractionated stereotactic radiosurgery combined with oral 5-fluorocytosine and valganciclovir prodrug therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Ad5-yCD/mutTKSR39rep-ADP adenovirus
- Fractionated Stereotactic Radiosurgery (fSRS)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Henry Ford Health System
Lead Sponsor