ADV-TK Improves Outcome of Recurrent High-Grade Glioma

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: 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 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Huazhong University of Science and Technology
• Collaborators: 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