ADV-TK Improves Outcome of Recurrent High-Grade Glioma

Phase 2

Completed

• Conditions: Malignant Glioma of Brain; Glioblastoma
• Interventions: Procedure: Surgery; Biological: ADV-TK/GCV; Drug: systemic chemotherapy

• Registration Number: NCT00870181
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-22
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Surgery	Patients received surgery or systemic chemotherapy or palliative care.
ADV-TK/GCV	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.
Control group	systemic chemotherapy	Patients received surgery or systemic chemotherapy or palliative care.

Primary Outcome Measures

Name	Time	Method
The primary end point was 6-month progression-free survival rate (PFS-6)	6 months

Secondary Outcome Measures

Name	Time	Method
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	the rate of complete response, plus partial response, plus stable disease
overall survival (OS)	3 years

Trial Locations

Locations (1)

Beijing YouAn Hospital; 🇨🇳 Beijing, Beijing, China