This Phase 2 study examines intraarterial cerebral infusion of ADV-TK, a replication-deficient adenovirus, combined with intravenous ganciclovir (GCV) in adults aged 18 or older with recurrent or progressive high-grade glioma (WHO grade 3–4); surgery and systemic chemotherapy are also listed as interventions. The aim is to assess the anti-tumor efficacy and safety of this approach. Participants must have a life expectancy of at least 12 weeks and adequate liver, kidney and blood function.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Histologically confirmed WHO grades 3 to 4 malignant glioma * Diagnosed recurrence or progression by clinical or radiological evidence * Fit for intraarterial infusion and intravenous chemotherapy * Adequate hepatic, renal, and hematologic function. * Legal age ≥18 years * Life expectancy ≥12 weeks * Eastern Cooperative Oncology Group performance (ECOG) ≥2 * Chemotherapy completion ≥4 weeks prior and recovery from drug induced toxicities. Exclusion Criteria: * Active pregnancy * Prior gene therapy * Second primary tumor * Gravidity, lactation, hypersensitivity to antiviral drugs, immunologic deficit, active uncontrolled infections * Requiring treatment with warfarin or any other anticoagulants