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

June 24, 2026 updated by: Institut Claudius Regaud

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

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.

Study Overview

Status

Completed

Conditions

Glioblastoma Multiforme

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Clermont-Ferrand, France
    - Centre Jean Perrin
  - Toulouse, France
    - Institut Claudius Regaud

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	time of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective response rate (RECIST and volumetric criteria) Time Frame: time of study	time of study
Median survival, 6 month and 1 year survival rates Time Frame: 6 month and 1 year	6 month and 1 year
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters Time Frame: time of study	time of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

Janssen-Cilag Ltd.

Investigators

Principal Investigator: Elizabeth MOYAL, Dr, Institut Claudius Regaud

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ducassou A, Uro-Coste E, Verrelle P, Filleron T, Benouaich-Amiel A, Lubrano V, Sol JC, Delisle MB, Favre G, Ken S, Laprie A, De Porre P, Toulas C, Poublanc M, Cohen-Jonathan Moyal E. alphavbeta3 Integrin and Fibroblast growth factor receptor 1 (FGFR1): Prognostic factors in a phase I-II clinical trial associating continuous administration of Tipifarnib with radiotherapy for patients with newly diagnosed glioblastoma. Eur J Cancer. 2013 Jun;49(9):2161-9. doi: 10.1016/j.ejca.2013.02.033. Epub 2013 Apr 6.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)