Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
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The purpose of this study is to determine the efficacy by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy.
Condition or disease
Drug: ZarnestraProcedure: standard Radiation therapy
Efficacy will be assessed by the determination of the Time To Progression (TTP) in patients with resectable GBM or non surgical GBM with a size less than 5 cm treated with the combination of ZARNESTRA plus Radiation therapy [ Time Frame: time of study ]
Secondary Outcome Measures :
Objective response rate (RECIST and volumetric criteria) [ Time Frame: time of study ]
Median survival, 6 month and 1 year survival rates [ Time Frame: 6 month and 1 year ]
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters [ Time Frame: time of study ]
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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:
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)