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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00209989
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Institut Claudius Regaud
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Elizabeth MOYAL, Dr
Principal Investigator Affiliation Institut Claudius Regaud
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Completed
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Jean Perrin, Clermont Ferrand, France

Status

Address

Centre Jean Perrin

Clermont Ferrand, ,

Institut Claudius Regaud, Toulouse, France

Status

Address

Institut Claudius Regaud

Toulouse, ,

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