Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- The primary end point was 6-month progression-free survival rate (PFS-6)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
ADV-TK/GCV
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.
干预措施: ADV-TK/GCV (Biological)
Control group
Patients received surgery or systemic chemotherapy or palliative care.
干预措施: Surgery (Procedure)
Control group
Patients received surgery or systemic chemotherapy or palliative care.
干预措施: systemic chemotherapy (Drug)
结局指标
主要结局
The primary end point was 6-month progression-free survival rate (PFS-6)
时间窗: 6 months
次要结局
- progression-free survival (PFS)(3 years)
- safety(1. at the time during treatments; 2. at 6-month; 3. at the end of 1-year following-up; 4. at the end of 2-year following up; 5. at the time the patient censored.)
- clinical benefit(at the end of 2nd ADK-TK/GCV therapy)
- overall survival (OS)(3 years)
研究者
Ding Ma
Director of Department of Gynecology and Obstetrics
Huazhong University of Science and Technology