Clinical trial · Interventional
ADV-TK Improves Outcome of Recurrent High-Grade Glioma
Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Malignant gliomas are the most common primary brain tumor in adults, but the prognosis for patients with these tumors remains poor despite advances in diagnosis and standard therapies such as surgery, radiation therapy, and chemotherapy. The advantages of ADV-TK gene therapy highlight its efficacy and safety for glioma patients. This clinical trial was conducted to assess the anti-tumor efficacy and safety of intraarterial cerebral infusion of replication-deficient adenovirus mutant ADV-TK, in combination with systemic intravenous GCV administration in patients with recurrent high-grade glioma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Malignant Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADV-TK/GCV | Biological | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
| systemic chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ADV-TK/GCV
- description
- ADV-TK was administered via intraarterial cerebral infusion. Systemic GCV therapy was delivered at a dose of 5mg/kg intravenous, every 12 h at 36 hours after ADV-TK therapy.
- interventionNames
- Biological: ADV-TK/GCV
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- Patients received surgery or systemic chemotherapy or palliative care.
- interventionNames
- Procedure: Surgery
- Drug: systemic chemotherapy
Primary outcomes (1)
- measure
- The primary end point was 6-month progression-free survival rate (PFS-6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJi N, Weng D, Liu C, Gu Z, Chen S, Guo Y, Fan Z, Wang X, Chen J, Zhao Y, Zhou J, Wang J, Ma D, Li N. Adenovirus-mediated delivery of herpes simplex virus thymidine kinase administration improves outcome of recurrent high-grade glioma. Oncotarget. 2016 Jan 26;7(4):4369-78. doi: 10.18632/oncotarget.6737. PMID 26716896