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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00870181
Recruitment Status : Completed
First Posted : March 27, 2009
Last Update Posted : June 25, 2013
Information provided by (Responsible Party):

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  (Clinical Trial)
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 : January 2008
Primary Completion Date : December 2011
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Outcome Measures

Primary Outcome Measures :
  1. The primary end point was 6-month progression-free survival rate (PFS-6) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 3 years ]
  2. overall survival (OS) [ Time Frame: 3 years ]
  3. 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. ]
  4. clinical benefit [ Time Frame: at the end of 2nd ADK-TK/GCV therapy ]
    the rate of complete response, plus partial response, plus stable disease

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00870181

China, Beijing
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
Study Director: Ma Ding, M.D. Tongji Hospital of HUST
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ding Ma, Director of Department of Gynecology and Obstetrics, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT00870181     History of Changes
Other Study ID Numbers: 2009HGG-01
First Posted: March 27, 2009    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue