HGG-01: ADV-TK Improves Outcome of Recurrent High-Grade Glioma

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT00870181

Collaborator

Beijing Tiantan Hospital (Other), Beijing Chao Yang Hospital (Other), Beijing Friendship Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Glioma of Brain Glioblastoma	Biological: ADV-TK/GCV Procedure: Surgery Drug: systemic chemotherapy	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2008

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: ADV-TK/GCV gene therapy
Active Comparator: Control group Patients received surgery or systemic chemotherapy or palliative care.	Procedure: Surgery Drug: systemic chemotherapy

Arm

Intervention/Treatment

Experimental: 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.

Biological: ADV-TK/GCV

gene therapy

Active Comparator: Control group

Patients received surgery or systemic chemotherapy or palliative care.

Procedure: Surgery

Drug: systemic chemotherapy

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

progression-free survival (PFS) [3 years]
overall survival (OS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing YouAn Hospital	Beijing	Beijing	China	100069

Sponsors and Collaborators

Huazhong University of Science and Technology
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Beijing Friendship Hospital

Investigators

Study Director: Ma Ding, M.D., Tongji Hospital of HUST

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ding Ma, Director of Department of Gynecology and Obstetrics, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00870181

Other Study ID Numbers:

2009HGG-01

First Posted:

Mar 27, 2009

Last Update Posted:

Jun 25, 2013

Last Verified:

Jun 1, 2013

Additional relevant MeSH terms:

Glioblastoma

Glioma

Study Results

No Results Posted as of Jun 25, 2013