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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00209989
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : November 24, 2011
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Institut Claudius Regaud

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date November 24, 2011
Study Start Date  ICMJE October 2005
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Objective response rate (RECIST and volumetric criteria)
  • Median survival, 6 month and 1 year survival rates
  • Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
Official Title  ICMJE Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma Multiforme
Intervention  ICMJE
  • Drug: Zarnestra
    ZARNESTRA 100 bid (phase II recommended dose defined in phase I)will be administered continuously from one week prior to start of radiation therapy until the last day of radiation therapy.
  • Procedure: standard Radiation therapy
    Radiotherapy will be focused on the initial tumour volume with a reasonable margin of safety (2 cm). A total dose of 60 Gray (Gy) will be given to the Clinical Target Volume
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
27
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00209989
Other Study ID Numbers  ICMJE 02 TETE 02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut Claudius Regaud
Study Sponsor  ICMJE Institut Claudius Regaud
Collaborators  ICMJE Janssen-Cilag Ltd.
Investigators  ICMJE
Principal Investigator: Elizabeth MOYAL, Dr Institut Claudius Regaud
PRS Account Institut Claudius Regaud
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP