GlioblastomaPhase 2DIRECTORNCT00941460
Comparison of Two Dosing Regimens of Temozolomide in Patients With Progressive or Recurrent Glioblastoma
A Phase 2 study testing Temozolomide in both arms in people with Glioblastoma, run by Prof. Dr. Wolfgang Wick at 16 sites in 3 countries.
Trial summary
For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Temozolomide in both arms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Sep 2009to Jun 2013
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
- Histological diagnosis of glioblastoma
- Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor if a patient undergoes a surgical procedure at recurrence prior to study entry.
- Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
- Informed consent
- Age 18-80 years
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- Karnofsky performance score > 50%
- Neutrophil counts > 1 500/µl
- Platelet counts > 100 000/µl
- Hemoglobin > 10 g/dl
- Serum creatinin < 1.5-fold upper normal range
- ASAT or ALAT < 3-fold upper normal range unless attributed to anticonvulsants
- Alkaline phosphatase < 3-fold upper normal range
- Women with childbearing potential must have a negative serum pregnancy test ≤14 days prior to study enrollment
- Willingness to apply contraception according to local requirements (as stated in patient information)
Who cannot join
- Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
- Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 and more than 6 cycles of adjuvant temozolomide are allowed
- Prior systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
- Allergy to or other intolerability of temozolomide
- Unable to undergo MRI
- Past medical history of diseases with poor prognosis, e.g. severe coronary heart disease, severe diabetes, immune deficiency, residual deficits after stroke, severe mental retardation
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- HIV infection
- Pregnancy
- Breast feeding
- Treatment within in any other clinical trial parallel to the treatment phase of the current study
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
Germany12 sites
Charite, Department of Neurosurgery
Berlin, 13353
Knappschaftskrankenhaus, Department of Neurology
Bochum, 44892
University Hospital Bonn, Department of Neurology
Bonn, 53105
Klinik für Allgemeine Neurochirurgie
Cologne, 50937
University Hospital Düsseldorf
Düsseldorf, 40001
Klinikum der Johann-Wolfgang von Goethe-Universität, Dr. Senckenbergisches Institut für Neuroonkologie, Zentrum für Neurologie und Neurochirurgie
Frankfurt, 60528
University Hospital Freiburg
Freiburg im Breisgau, 79106
University Hospital Heidelberg, Department of Neurooncology
Heidelberg, 69120
Saarland University, Department of Neurosurgery
Homburg/ Saar, 66421
Klinik und Poliklinik für Neurochirurgie
Leipzig, 04103
Ludwig Maximilians University of Munich , Grosshadern Hospital, Department of Neurosurgery
Munich, 81377
University of Regensburg, Department of Neurology
Regensburg, 93053
Austria2 sites
Landesnervenklinik Wagner-Jauregg
Linz, 4020
Medical University Vienna, Department of Internal Medicine I
Vienna, 1090
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois and University of Lausanne
Lausanne
University Hospital Zurich, Department of Neurology
Zurich, CH, 8091
About this study
Official title: Dose-intensified Rechallenge With Temozolomide, One Week On One Week Off Versus Three Weeks On One Week Off in Patients With Progressive or Recurrent Glioblastoma
For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.
- Conditions
- Glioblastoma
- Being tested
- Temozolomide in both arms
- Keywords
- progressive or recurrent glioblastoma, temozolomide, dose intensification, comparison of two dosing regimens
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temozolomide in both armsDrug
Also called Temodal
initial dose 120 mg/m2 in arm A
Temozolomide in both armsDrug
Also called Temodal
initial dose 80 mg/m2 in arm B
| Study group | Role | What they receive |
|---|---|---|
| one week on one week off | Experimental | One week on temozolomide is followed by a week without temozolomide. Receives: Drug: Temozolomide in both arms |
| three weeks on, one week off | Experimental | Temozolomide is given over 3 weeks, followed by a week without temozolomide. Receives: Drug: Temozolomide in both arms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to treatment failure. Treatment failure is reached (i) upon tumor progression as outlined in protocol (ii) if treatment has to be terminated due to toxicity or (iii) if the patient dies for any reason.
Measured: up to one year
Secondary outcomes (1)
progression free survival
Measured: up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Wolfgang Wick
- Sponsor type
- University, hospital or other
- Collaborators
- Essex Pharma GmbH
- Responsible party
- Sponsor-investigator, Prof. Dr. Wolfgang Wick, Heidelberg University
- Investigators
- Michael Weller, Prof. Dr., Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941460
- Sponsor's protocol ID
- DIRECTOR
- Other IDs
- 2008-006871-60, ISRCTN68738654, 2008
- Acronym
- DIRECTOR
- Status last verified
- Aug 2014
- First submitted
- 16 Jul 2009
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-intensified Rechallenge With Temozolomide, One Week On One Week Off Versus Three Weeks On One Week Off in Patients With Progressive or Recurrent Glioblastoma
- ClinicalTrials.gov ID
- NCT00941460
- Acronym / sponsor ID
- DIRECTOR / DIRECTOR
- Conditions
- Glioblastoma
- Keywords
- progressive or recurrent glioblastoma, temozolomide, dose intensification, comparison of two dosing regimens
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Prof. Dr. Wolfgang WickUniversity, hospital or other
- Collaborators
- Essex Pharma GmbH
- Study start
- Sep 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Jul 2009 (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.
For patients with progressive or recurrent glioblastoma there is no standard therapy. One strategy is re-exposure to temozolomide in a higher dose. This increase in dosing can be done by 2 regimens. Aim of this study is to compare these 2 dosing regimens concerning toxicity. In study arm A patients receive temozolomide for one week, followed by a week without temozolomide. In study arm B patients receive temozolomide for three weeks, followed by a week without temozolomide. The regimen that is less toxic will be selected for further evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one week on one week off | Experimental | Drug: Temozolomide in both armsOne week on temozolomide is followed by a week without temozolomide. |
| three weeks on, one week off | Experimental | Drug: Temozolomide in both armsTemozolomide is given over 3 weeks, followed by a week without temozolomide. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Progressive or recurrent glioblastoma documented by MRI no earlier than 180 days after first surgery for glioblastoma and no earlier than 90 days after completion of radiotherapy.
- Histological diagnosis of glioblastoma
- Tissue available for the determination of MGMT promoter methylation in the primary tumor or from the recurrent tumor if a patient undergoes a surgical procedure at recurrence prior to study entry.
- Prior treatment with temozolomide administered concomitantly with radiotherapy and at least for two cycles (5/28) as an adjuvant treatment
- Informed consent
Key exclusion criteria (10 listed)
- Progressive or recurrent glioblastoma documented by MRI earlier than 180 days after first surgery for glioblastoma and earlier than 90 days after completion of radiotherapy.
- Treatment with any chemotherapy other than temozolomide according to the schedule of the EORTC NCIC trial (Stupp et al. N Engl J Med 2005;352:987-996) except that an adjuvant starting dose of 200 mg/m2 and more than 6 cycles of adjuvant temozolomide are allowed
- Prior systemic or local treatment with DNA-damaging agents, tyrosine kinase inhibitors or anti-angiogenic agents for any cancer
- Allergy to or other intolerability of temozolomide
- Unable to undergo MRI
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 |
|---|---|---|
| Temozolomide in both armsAlso: Temodalinitial dose 120 mg/m2 in arm A | Drug | one week on one week off |
| Temozolomide in both armsAlso: Temodalinitial dose 80 mg/m2 in arm B | Drug | three weeks on, one week off |
Primary outcome
Median time to treatment failure. Treatment failure is reached (i) upon tumor progression as outlined in protocol (ii) if treatment has to be terminated due to toxicity or (iii) if the patient dies for any reason.
Time frame: up to one year
1 secondary outcome
progression free survival
Time frame: up to two years
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 15 Aug 2014.
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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.
Michael Weller, Prof. Dr. study chair
University of Zurich
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Temozolomide in both arms in people with Glioblastoma, run by Prof. Dr. Wolfgang Wick at 16 sites in 3 countries.
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 15 inclusion and 10 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 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Germany, Austria, Switzerland. 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?
Median time to treatment failure. Treatment failure is reached (i) upon tumor progression as outlined in protocol (ii) if treatment has to be terminated due to toxicity or (iii) if the patient dies for any reason. (time frame: up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2014.