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


Phase 2
18 Years
N/A
Not Enrolling
Both
Malignant Glioma of Brain, Glioblastoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Ma Ding, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Tongji Hospital of HUST

Authority:

China: Ministry of Health

Study ID:

2009HGG-01

NCT ID:

NCT00870181

Start Date:

January 2008

Completion Date:

December 2012

Related Keywords:

  • Malignant Glioma of Brain
  • Glioblastoma
  • Glioblastoma
  • Glioma

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