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

Primary Purpose

Glioblastoma Multiforme

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Zarnestra
standard Radiation therapy
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme focused on measuring Glioblastoma Multiforme, Zarnestra, Radiation therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Jean Perrin
  • Institut Claudius Regaud

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
November 23, 2011
Sponsor
Institut Claudius Regaud
Collaborators
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00209989
Brief Title
Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
Official Title
Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
Collaborators
Janssen-Cilag Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme
Keywords
Glioblastoma Multiforme, Zarnestra, Radiation therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Zarnestra
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
standard Radiation therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Objective response rate (RECIST and volumetric criteria)
Time Frame
time of study
Title
Median survival, 6 month and 1 year survival rates
Time Frame
6 month and 1 year
Title
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters
Time Frame
time of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth MOYAL, Dr
Organizational Affiliation
Institut Claudius Regaud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
Country
France
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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