Glioblastoma MultiformePhase 2NCT00209989
Phase II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
A Phase 2 study testing Zarnestra and standard Radiation therapy in people with Glioblastoma Multiforme, run by Institut Claudius Regaud at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Zarnestra and standard Radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 27 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2005to Jun 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 (1.5109/l) Platelet count <100,000/mm3 (100109/l)
Show all 18Show fewer
- 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 locations and contacts
2 sites in 1 country.
France2 sites
Centre Jean Perrin
Clermont-Ferrand
Institut Claudius Regaud
Toulouse
About this study
Official title: 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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Zarnestra, standard Radiation therapy
- Keywords
- Glioblastoma Multiforme, Zarnestra, Radiation therapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZarnestraDrug
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.
standard Radiation therapyProcedure or surgery
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: time of study
Secondary outcomes (3)
Objective response rate (RECIST and volumetric criteria)
Measured: time of study
Median survival, 6 month and 1 year survival rates
Measured: 6 month and 1 year
Safety of combination therapy of ZARNESTRA and RT, based on laboratory and clinical parameters
Measured: time of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Responsible party
- Sponsor
- Investigators
- Elizabeth MOYAL, Dr, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209989
- Sponsor's protocol ID
- 02 TETE 02
- Status last verified
- Jun 2026
- First submitted
- 13 Sep 2005
- Last updated
- 26 Jun 2026
- Results posted
- No
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.
PubMed 23566417
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Trial to Assess the Radiosensitizing Effect of ZARNESTRA in Patients With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00209989
- Acronym / sponsor ID
- 02 TETE 02
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme, Zarnestra, Radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Janssen-Cilag Ltd.
- Study start
- Oct 2005
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZarnestraZARNESTRA 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. | Drug | – |
| standard Radiation therapyRadiotherapy 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 | Procedure or surgery | – |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Results publication: PubMed 23566417Ducassou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth MOYAL, Dr principal investigator
Institut Claudius Regaud
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zarnestra and standard Radiation therapy in people with Glioblastoma Multiforme, run by Institut Claudius Regaud at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00209989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.