GlioblastomaPhase 2NCT01044225
Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma
A Phase 2 study testing Cetuximab and Cilengitide EMD 121974 in people with Glioblastoma, run by Bart Neyns at 6 sites in Belgium.
Trial summary
The investigators propose to conduct a multicenter, open-label, randomized, phase II study in patients with newly diagnosed glioblastoma (CeCil). Patients should meet all eligibility criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation could be demonstrated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Cetuximab and Cilengitide EMD 121974
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 6 sitesBelgium
- Study dates
- Sep 2009to Sep 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
- Written informed consent
- Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV, including glioblastoma subtypes, e.g. gliosarcoma).
- Tumor tissue specimens from the glioblastoma surgery or open biopsy (FFPE block) must be available for MGMT gene promoter status analysis and central pathology review and must have been submitted as part of the screen procedure for the CENTRIC phase III study
- MGMT gene promoter status determined as NOT methylated during the screen procedure for the CENTRIC phase III study
- Males or females ≥18 years of age.
- Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
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- Available post-operative Gd-MRI performed within 48 hours after surgery
- Stable or decreasing dose of steroids for 5 days prior to randomization.
- Eastern Cooperative Oncology Group performance score (ECOG PS) of 0-1.
- Meets one of the following recursive partitioning analysis (RPA) classifications:
- Class III (Age <50 years and ECOG PS 0).
- Class IV (meeting one of the following criteria: a) Age <50 years and ECOG PS 1 or b) Age ≥50 years, underwent prior partial or total tumor resection, Mini Mental State Examination [MMSE] ≥27).
- Class V (meeting one of the following criteria: a) Age ≥50 years and underwent prior partial or total tumor resection, MMSE <27 or b) Age ≥50 years and underwent prior open tumor biopsy only).
- Laboratory values
- Absolute neutrophil count 1500/mm3.
- Platelets 100,000/mm3.
- Creatinin 1.5 x upper limit of normal (ULN) or creatinine clearance rate 60 mL/min.
- Hemoglobin 10 g/dL.
- Total bilirubin 1.5 x the ULN.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 2.5 x ULN (except when attributable to anticonvulsants).
- Alkaline phosphatase 2.5 x ULN.
- Prothrombin time (PT) international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits.
Who cannot join
- Prior chemotherapy within the last 5 years.
- Prior RT of the head.
- Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of Cilengitide.
- Prior systemic anti-angiogenic therapy.
- Placement of Gliadel® wafer at surgery.
- Planned surgery for other diseases (e.g. dental extraction).
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- History of recent peptic ulcer disease within 6 months of enrollment.
- History of malignancy. Subjects with curatively treated cervical carcinoma in situ or basal cell carcinoma of the skin, or subjects who have been free of other malignancies for 5 years are eligible for this study.
- History of coagulation disorder associated with bleeding or recurrent thrombotic events.
- Clinically manifest myocardial insufficiency or history of myocardial infarction during the past 6 months; or uncontrolled arterial hypertension.
- Inability to undergo Gd-MRI.
- Concurrent illness, including severe dermatological conditions or infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
- Subject is pregnant or is currently breast-feeding, anticipates becoming pregnant/ impregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessary, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment.
- Current alcohol dependence or drug abuse.
- Known hypersensitivity to the study treatment.
- Legal incapacity or limited legal capacity.
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- Treatment with prohibited concomitant medication as defined in Section
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Belgium6 sites
Onze-Lieve-Vrouwziekenhuis
Aalst, Aalst, 9300
ZNA Middelheim
Antwerp, Antwerpen, 2020
GHdC Charleroi
Charleroi, Charleroi, 6000
ZOL Campus Sint-Jan
Genk, 3600
UZ Gent
Ghent, 9000
UCL de Mont-Godinne
Yvoir, 5530
About this study
Official title: CeCil: A Randomized, Non-comparative Clinical Trial of the Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma
The investigators propose to conduct a multicenter, open-label, randomized, phase II study in patients with newly diagnosed glioblastoma (CeCil). Patients should meet all eligibility criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation could be demonstrated. The treatment backbone in both study arms will consist of postoperative radiation therapy with concomitant daily temozolomide, followed by 6 cycles of temozolomide according to a 21 out of 28 days regimen (as in the experimental arm of the RTOG 0525 / EORTC 26052-22053 phase III study). In study arm (A) Cilengitide (at a dose of 2000 mg by iv administration, 2x/week) will be added to this backbone while in the second study arm (B), Cetuximab will be added (at an initial dose of 400 mg/m² administered by intravenous infusion over 2 hours and followed by a weekly dose of 250 mg/m² iv over 1 hours). In both study arms, treatment will be administered for 52 consecutive treatment weeks. The 1-year overall survival (1y-OS) following randomization will serve as the primary endpoint in both study arms.
- Conditions
- Glioblastoma
- Being tested
- Cetuximab, Cilengitide EMD 121974
- Keywords
- newly diagnosed glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
An initial dose of 400 mg/m² IV over 2 hours and followed by a weekly dose of 250 mg/m² over 1 hour.
Cilengitide EMD 121974Drug
A dose of 2000 mg by IV administration 2 weekly.
| Study group | Role | What they receive |
|---|---|---|
| Cilengitide EMD 121974 | Active comparator | A dose of 2000 mg by iv administration 2 weekly. Receives: Drug: Cilengitide EMD 121974 |
| Cetuximab | Active comparator | An initial dose of 400 mg/m² IV over 2 hours and followed by a weekly dose of 250 mg/m² over 1 hour. Receives: Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
the 1 year overall survival
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Results of the phase III RTOG0525 trial made the manufacturer of cilengitide decide to end their support to the trial
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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bart Neyns
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bart Neyns, Universitair Ziekenhuis Brussel
- Investigators
- Bart Neyns, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044225
- Sponsor's protocol ID
- 2009-012324-83
- Other IDs
- 2009
- Status last verified
- Mar 2012
- First submitted
- 6 Jan 2010
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CeCil: A Randomized, Non-comparative Clinical Trial of the Effect of Radiation Therapy Plus Temozolomide Combined With Cilengitide or Cetuximab on the 1-year Overall Survival of Patients With Newly Diagnosed MGMT-promoter Unmethylated Glioblastoma
- ClinicalTrials.gov ID
- NCT01044225
- Acronym / sponsor ID
- 2009-012324-83
- Conditions
- Glioblastoma
- Keywords
- newly diagnosed glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Results of the phase III RTOG0525 trial made the manufacturer of cilengitide decide to end their support to the trial
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Bart NeynsUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 7 Jan 2010 (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 investigators propose to conduct a multicenter, open-label, randomized, phase II study in patients with newly diagnosed glioblastoma (CeCil). Patients should meet all eligibility criteria for the CENTRIC phase III trial at the exception that no MGMT-promoter methylation could be demonstrated. The treatment backbone in both study arms will consist of postoperative radiation therapy with concomitant daily temozolomide, followed by 6 cycles of temozolomide according to a 21 out of 28 days regimen (as in the experimental arm of the RTOG 0525 / EORTC 26052-22053 phase III study). In study arm (A) Cilengitide (at a dose of 2000 mg by iv administration, 2x/week) will be added to this backbone while in the second study arm (B), Cetuximab will be added (at an initial dose of 400 mg/m² administered by intravenous infusion over 2 hours and followed by a weekly dose of 250 mg/m² iv over 1 hours). In both study arms, treatment will be administered for 52 consecutive treatment weeks. The 1-year overall survival (1y-OS) following randomization will serve as the primary endpoint in both study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilengitide EMD 121974 | Active comparator | Drug: Cilengitide EMD 121974A dose of 2000 mg by iv administration 2 weekly. |
| Cetuximab | Active comparator | Drug: CetuximabAn initial dose of 400 mg/m² IV over 2 hours and followed by a weekly dose of 250 mg/m² over 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Written informed consent
- Newly diagnosed histologically proven supratentorial glioblastoma (World Health Organization [WHO] Grade IV, including glioblastoma subtypes, e.g. gliosarcoma).
- Tumor tissue specimens from the glioblastoma surgery or open biopsy (FFPE block) must be available for MGMT gene promoter status analysis and central pathology review and must have been submitted as part of the screen procedure for the CENTRIC phase III study
- MGMT gene promoter status determined as NOT methylated during the screen procedure for the CENTRIC phase III study
- Males or females ≥18 years of age.
Key exclusion criteria (19 listed)
- Prior chemotherapy within the last 5 years.
- Prior RT of the head.
- Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of Cilengitide.
- Prior systemic anti-angiogenic therapy.
- Placement of Gliadel® wafer at surgery.
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 |
|---|---|---|
| CetuximabAn initial dose of 400 mg/m² IV over 2 hours and followed by a weekly dose of 250 mg/m² over 1 hour. | Drug | Cetuximab |
| Cilengitide EMD 121974A dose of 2000 mg by IV administration 2 weekly. | Drug | Cilengitide EMD 121974 |
Primary outcome
the 1 year overall survival
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Results of the phase III RTOG0525 trial made the manufacturer of cilengitide decide to end their support to the trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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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.
Bart Neyns principal investigator
Universitair Ziekenhuis Brussel
6 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 Cetuximab and Cilengitide EMD 121974 in people with Glioblastoma, run by Bart Neyns at 6 sites in Belgium.
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 22 inclusion and 19 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: stopped early, as of the sponsor's last update on 22 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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 was stopped early (reason given: Results of the phase III RTOG0525 trial made the manufacturer of cilengitide decide to end their support to the trial). Results are not available in the source record.
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?
the 1 year overall survival (time frame: 1 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 22 Mar 2012; AzTrials last refreshed its copy on 7 Nov 2026.