Back to resultsADV-TK Improves Outcome of Recurrent High-Grade Glioma (HGG-01)
Primary Purpose
Malignant Glioma of Brain, Glioblastoma
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ADV-TK/GCV
Surgery
systemic chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Glioma of Brain
Eligibility 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
Sites / Locations
- Beijing YouAn Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ADV-TK/GCV
Control group
Arm Description
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.
Patients received surgery or systemic chemotherapy or palliative care.
Outcomes
Primary Outcome Measures
The primary end point was 6-month progression-free survival rate (PFS-6)
Secondary Outcome Measures
progression-free survival (PFS)
overall survival (OS)
safety
clinical benefit
the rate of complete response, plus partial response, plus stable disease
Full Information
NCT ID
NCT00870181
First Posted
March 26, 2009
Last Updated
June 22, 2013
Sponsor
Huazhong University of Science and Technology
Collaborators
Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00870181
Brief Title
ADV-TK Improves Outcome of Recurrent High-Grade Glioma
Acronym
HGG-01
Official Title
Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
Collaborators
Beijing Tiantan Hospital, Beijing Chao Yang Hospital, Beijing Friendship Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma of Brain, Glioblastoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ADV-TK/GCV
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients received surgery or systemic chemotherapy or palliative care.
Intervention Type
Biological
Intervention Name(s)
ADV-TK/GCV
Intervention Description
gene therapy
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Type
Drug
Intervention Name(s)
systemic chemotherapy
Primary Outcome Measure Information:
Title
The primary end point was 6-month progression-free survival rate (PFS-6)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
progression-free survival (PFS)
Time Frame
3 years
Title
overall survival (OS)
Time Frame
3 years
Title
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.
Title
clinical benefit
Description
the rate of complete response, plus partial response, plus stable disease
Time Frame
at the end of 2nd ADK-TK/GCV therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ma Ding, M.D.
Organizational Affiliation
Tongji Hospital of HUST
Official's Role
Study Director
Facility Information:
Facility Name
Beijing YouAn Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
26716896
Citation
Ji N, Weng D, Liu C, Gu Z, Chen S, Guo Y, Fan Z, Wang X, Chen J, Zhao Y, Zhou J, Wang J, Ma D, Li N. Adenovirus-mediated delivery of herpes simplex virus thymidine kinase administration improves outcome of recurrent high-grade glioma. Oncotarget. 2016 Jan 26;7(4):4369-78. doi: 10.18632/oncotarget.6737.
Results Reference
derived
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ADV-TK Improves Outcome of Recurrent High-Grade Glioma
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