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

Inclusion criteria

• Patients must have pathologically confirmed (histology or cytology), resectable or non resectable, glioblastoma multiforme with a size < 5 cm on MRI if non resectable
• Patients must be at least 7 days but no more than 2 months since surgery or biopsy.
• Patients must have an ECOG Performance Status ≤ 2.
• Patients must be aged 18
• Patient has signed the informed consent form

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