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Completed

NCT Number: NCT00870181

ADV-TK Improves Outcome of Recurrent High-Grade Glioma

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.

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Key information

Conditions

Malignant Glioma of Brain Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing YouAn Hospital

Beijing, Beijing Municipality, 100069, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADV-TK/GCV

Biological

gene therapy

Surgery

Procedure

systemic chemotherapy

Drug

Primary outcomes

  1. The primary end point was 6-month progression-free survival rate (PFS-6)

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital
  • Beijing Tiantan Hospital

Registry information

Official study title

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

Acronym: HGG-01

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Mar 27, 2009
Registry last updated
Jun 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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