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Brain – Glioblastoma Multiforme treatment details. Radiation, Gene Therapy, Surgery.

Martin-Luther Universitat, Halle-Wittenberg, Halle, Germany.

Survival: monthsCountry:Germany
Toxiciy Grade:5City/State/Province:Halle
Treatments:Radiation, Gene Therapy, SurgeryHospital:Martin-Luther Universitat, Halle-Wittenberg
Drugs:Journal:Link
Date:Nov 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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