Overview
ADV-TK Improves Outcome of Recurrent High-Grade Glioma
Status:
Completed
Completed
Trial end date:
2012-12-01
2012-12-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Huazhong University of Science and TechnologyCollaborators:
Beijing Chao Yang Hospital
Beijing Friendship Hospital
Beijing Tiantan Hospital
Criteria
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