Glioblastoma, Malignant Glioma of Brain
Conditions
Brief 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.
Interventions
BIOLOGICALADV-TK/GCV
gene therapy
PROCEDURESurgery
DRUGsystemic chemotherapy
Sponsors
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Beijing Friendship Hospital
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point was 6-month progression-free survival rate (PFS-6) | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival (PFS) | 3 years | — |
| overall survival (OS) | 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 | the rate of complete response, plus partial response, plus stable disease |
Countries
China
Outcome results
None listed