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

NCT ID: NCT00209989

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glioblastoma Multiforme

Keywords

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Glioblastoma Multiforme Zarnestra Radiation therapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DRUG

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag Ltd.

INDUSTRY

Sponsor Role collaborator

Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth MOYAL, Dr

Role: PRINCIPAL_INVESTIGATOR

Institut Claudius Regaud

Locations

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Centre Jean Perrin

Clermont-Ferrand, , France

Site Status

Institut Claudius Regaud

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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02 TETE 02

Identifier Type: -

Identifier Source: org_study_id