ADV-TK Improves Outcome of Recurrent High-Grade Glioma

Huazhong University of Science and Technology47 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Malignant Glioma of Brain Glioblastoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The primary end point was 6-month progression-free survival rate (PFS-6)

Time frame: 6 months

Secondary Outcomes

progression-free survival (PFS)

Time frame: 3 years

overall survival (OS)

Time frame: 3 years

safety

Time frame: 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

the rate of complete response, plus partial response, plus stable disease

Time frame: at the end of 2nd ADK-TK/GCV therapy