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

Phase 2
18 Years
Not Enrolling
Glioblastoma Multiforme

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Trial Information

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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

time of study

Safety Issue:


Principal Investigator

Elizabeth MOYAL, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

02 TETE 02



Start Date:

October 2005

Completion Date:

June 2011

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Zarnestra
  • Radiation therapy
  • Glioblastoma