Phase I Study of Adenovirus-Based Double Suicide Gene Therapy Combined with Stereotactic Radiosurgery for Patients Undergoing Surgery for Recurrent or Progressive High-Grade Astrocytomas

What this Trial Is About

Researchers are studying patients with recurrent glioblastoma or progressive high-grade astrocytoma who are scheduled for repeat surgery. This Phase I trial aims to find the highest safe dose of a modified oncolytic adenovirus given with fractionated stereotactic radiosurgery in these patients. The study combines gene therapy with radiation to evaluate potential treatment options for these brain tumors. Participants will receive a single injection of the Ad5-yCDmutTKSR39rep-ADP adenovirus directly into the tumor area after surgery, at one of three increasing dose levels. This gene therapy is combined with oral medications 5-fluorocytosine and valganciclovir, followed by fractionated stereotactic radiosurgery. Treatment continues until unacceptable side effects, tumor progression, or withdrawal. The study includes a monitoring period before starting any new cancer therapy. During the study, patients will be closely monitored for safety and immune response through blood tests and assessments at multiple time points before and after surgery, up to 90 days. Researchers will measure the maximum tolerated dose and observe changes in immune markers. The study lasts through treatment and follow-up, with a 30-day observation before other therapies begin, ensuring comprehensive safety and response evaluation.

Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.