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Brain – Glioblastoma Multiforme treatment details. Biologic therapy, Gene Therapy, Surgery.

University of California, San Francisco, San Francisco, Californai, United States.

Survival: monthsCountry:United States
Toxiciy Grade:5City/State/Province:San Francisco, Californai
Treatments:Biologic therapy, Gene Therapy, SurgeryHospital:University of California, San Francisco
Drugs:Journal:Link
Date:Dec 2003

Description:

Patients: This Phase I/II multi-institutional trial involved 30 patients with progressive or recurrent glioblastoma multiforme.

Treatment: Treatment consisted of surgical resection of tumor followed by injections of vector producing cells (VPC) (a type of gene therapy) into the brain adjacent to the cavity. An Ommaya reservoir placed after surgery was used to inject a further dose of VPC after surgery, followed by ganciclovir. Further gene therapy was given at 28-day intervals.

Toxicity: Two patients died of deep vein thrombosis and pulmonary embolism. The most frequent toxicities were neurological. Approximately 90% of patients experienced at least one serious adverse event. Serious adverse events while on treatment included: seizures, acute meningeal/ventricular reaction, hemiplegia/hemiparesis, speech problem, subdural hematoma, cerebral edema, intracerebral hemorrhage, lymphopenia, pancytopenia, hyponatremia, fever, pneumonia, septicemia (from catheter), perforated ulcer, ileus, and Ommaya reservoir complications.

Results: Median survival was 8.4 months.

Support: Supported by a grant from Genetic Therapy, Inc. and MD/Novarts Pharmaceuticals. These companies are involved in the production of VPC.

Correspondence: Michael Prados, MD


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