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

This study has been completed.
Sponsor:
Collaborators:
Beijing Tiantan Hospital
Beijing Chao Yang Hospital
Beijing Friendship Hospital
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00870181
First received: March 26, 2009
Last updated: June 22, 2013
Last verified: June 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Adenovirus-Mediated Delivery of Herpes Simplex Virus Thymidine Kinase Administration Improves Outcome of Recurrent High-Grade Glioma

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • The primary end point was 6-month progression-free survival rate (PFS-6) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • progression-free survival (PFS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • overall survival (OS) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • clinical benefit [ Time Frame: at the end of 2nd ADK-TK/GCV therapy ] [ Designated as safety issue: Yes ]
    the rate of complete response, plus partial response, plus stable disease


Enrollment: 47
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870181

Locations
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
Investigators
Study Director: Ma Ding, M.D. Tongji Hospital of HUST
  More Information

No publications provided

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
Study First Received: March 26, 2009
Last Updated: June 22, 2013
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on September 16, 2014