ADV-TK Improves Outcome of Recurrent High-Grade Glioma

Glioblastoma Clinical Trial

— HGG-01  

Official title:

Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870181
• Other study ID #: 2009HGG-01
• Status: Completed
• Phase: Phase 2
• First received: March 26, 2009
• Last updated: June 22, 2013
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: June 2013
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Malignant Glioma of Brain

Intervention

Biological:
• ADV-TK/GCV
gene therapy

Procedure:
• Surgery

Drug:
• systemic chemotherapy

Locations

Country	Name	City	State
China	Beijing YouAn Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology	Beijing Chao Yang Hospital, Beijing Friendship Hospital, Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary end point was 6-month progression-free survival rate (PFS-6)		6 months	No
Secondary	progression-free survival (PFS)		3 years	No
Secondary	overall survival (OS)		3 years	No
Secondary	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.	Yes
Secondary	clinical benefit	the rate of complete response, plus partial response, plus stable disease	at the end of 2nd ADK-TK/GCV therapy	Yes