Phase I/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