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Brain Cancer treatment details. Gene Therapy. Radiation. Surgery. Martin-Luther Universitat, Halle-Wittenberg, Halle, Germany



Survival: 12.0 months
   
Toxicity Grade: 5
   
Treatments: Gene Therapy
Radiation
Surgery
   
Drugs:
Country: Germany
   
City/State/Province: Halle
   
Hospital: Martin-Luther Universitat, Halle-Wittenberg
   
Journal: Link
   
Date: 11/2000

Description:
Patients: This Phase III trial involved 248 patients with newly diagnosed, previously untreated glioblastoma multiforme. Patients were divided into two groups gene therapy group (124 patients) and control group (124 patients).

Treatment: Both groups received surgical removal of the tumor followed by radiotherapy. In addition to this therapy, the gene therapy group received vector producing cells (gene therapy herpes simplex virus thymidine kinase (HSV-tk) gene) and subsequent systemic treatment with ganciclovir.

Toxicity: There were ten deaths (5 in each group) in the early postoperative and gene therapy period. These causes of death included: intracerebral hematoma, cerebral edema, pulmonary embolism, cardiac arrhythmia, cardio-respiratory failure, pneumonia/ septicemia, and renal failure. Other serious adverse events included: neurological, hematomas, cardiovascular, gastrointestinal, metabolic, infections, respiratory, urinary, skin, pain, infection, and fever.

Results: Median survival was 365 days (12.0 months) for the gene therapy group and 354 days (11.6 months) for the control group.

Correspondence: Dr. Nikolai G. Rainov

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