Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme

Exclusion Criteria

• •Patients with unresectable glioblastoma with a size \>5 cm on MRI
• •Patients with clinically apparent leptomeningeal metastases
• •Patients with uncontrolled seizures despite standard anticonvulsant therapy
• •Any prior systemic treatment (chemotherapy, immunotherapy, hormonal therapy) for glioblastoma multiforme
• •Significantly abnormal haematological status as judged by:
• •Absolute neutrophil count (ANC) \< 1500/mm3 (1.5\*109/l) Platelet count \<100,000/mm3 (100\*109/l)
• •Serum bilirubin \>2 mg/dl (\>34 mmol/l) or Transaminase \>2.5x the upper limit of institutional normal or Creatinine \>1.5 mg/dl (\>132 mmol/l)
• •Inability to co-operate with the treatment protocol
• •Patients who cannot undergo imaging evaluations
• •Participation in an investigational drug trial in the 30 days prior to selection
• •Pregnant or nursing mothers. (Female patients of childbearing potential must use adequate contraception.)
• •Any malignancy within the past five years. Exceptions are: superficial basal cell carcinoma or non-metastatic squamous cell cancer of the skin, cervix cancer (cervical intra-epithelial neoplasia -CIN or FIGO stage 1) or prostate intra-epithelial neoplasia (PIN), biochemical relapse free for at least 3 years.
• •Any prior systemic chemotherapy in the past five years for any malignancy in the medical history
• •Any concurrent disease that in the opinion of the investigator would constitute a hazard for participating in this study
• •Known sensitivity to imidazole derivatives
• •Patients under law protection
• •Medical history of phlebitis or pulmonary embolism, thrombocytosis, myocardiopathy, or other relevant cardiac pathology (auricular flutter, auricular fibrillation)
• •Medical history of immuno-allergic pneumopathy