Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4Phase 2ExCentricNCT01124240
Temozolomide and Procarbazine With Cilengitide for Patients With Glioblastoma Multiforme Without Methylation of the MGMT Promoter Gene
A Phase 2 study testing Cilengitide in people with Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4, run by Northern Sydney and Central Coast Area Health Service at 1 site in Australia.
Trial summary
Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption. Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4
- What is being tested?
- Cilengitide
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2009to Jan 2014
- 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
- Newly diagnosed supratentorial GBM (WHO Grade IV,including GBM subtypes, e.g. gliosarcoma), histopathologically confirmed by central assessment as part of the screening for the CENTRIC trial.
- Males or females ≥18 years of age.
- Proven unmethylated MGMT gene promoter status, centrally assessed as part of the screening for the CENTRIC trial.
- Written informed consent for the present trial obtained before undergoing any study-related activities. The informed consent also allows access to all information obtained during the screening for the CENTRIC trial, notably the result of the MGMT testing.
- Available post-operative Gd-MRI performed within <48 hours after surgery (in case it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization).
- Stable or decreasing dose of steroids for >5 days prior to randomization.
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- ECOG PS of 0-1.
- Interval of ≥2 weeks but ≤7 weeks after surgery or biopsy before first administration of study treatment.
- Meets one of the following RPA classifications:
- Class III (age <50 years and ECOG PS 0).
- Class IV (meeting one of the following criteria:
- Age <50 years and ECOG PS 1 or
- Age ≥50 years, underwent prior partial or total tumor resection, Mini Mental State Examination [MMSE]≥27).
- Class V (meeting one of the following criteria:
- Age ≥50 years and underwent prior partial or total tumour resection, MMSE <27 or
- Age ≥50 years and underwent prior tumor biopsy only).
- Laboratory values (within 2 week prior to randomization):
- Absolute neutrophil count ≥1500/mm3.
- Platelets ≥ 100,000/mm3.
- Creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance rate ≥60 mL/min
- Prothrombin time (PT) international normalized ratio (INR) and partial thromboplastin time (PTT) within normal limits.
- 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.
Who cannot join
- Subjects are not eligible for this study, if they fulfill one or more of the following exclusion criteria:
- Prior chemotherapy within the last 5 years.
- Prior RTX of the head.
- Receiving concurrent investigational agents or has received an investigational agent(s) within the past 30 days prior to the first dose of Cilengitide .
- Prior systemic antiangiogenic therapy.
- Placement of Gliadel® wafer at surgery.
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- Treatment with a prohibited concomitant medication.
- Planned surgery for other diseases (e.g. dental extraction).
- History of recent peptic ulcer disease (endoscopically proven gastric ulcer, duodenal ulcer, or esophageal ulcer) 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 (NYHA III, IV) or history of myocardial infarction during the past 6 months. Uncontrolled arterial hypertension.
- Concurrent illness, including severe infection, which may jeopardize the ability of the subject to receive the procedures outlined in this protocol with reasonable safety.
- Subject is pregnant (positive serum beta human chorionic gonadotropin [β-HCG] test at screening) 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 pessar, 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.
- Inability to undergo Gd-MRI.
- 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 of family members who suffer(ed) from such.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales, 2065
Sally McCowatt, Rn, 61299265049, smccowat@nsccahs.health.nsw.gov.au
Helen Wheeler, MBBS, 61299267111, hrwheeler@optusnet.com.au
About this study
Official title: Phase 11 Study of Cilengitide in Combination With Concurrent Chemotherapy and Radiotherapy Followed by Protracted Daily Low Dose Temozolomide and Low Dose Procarbazine D1 - 20 in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Promoter Gene
Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption.
Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week).
After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.
- Being tested
- Cilengitide
- Keywords
- Glioblastoma Multiforme
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CilengitideDrug
Also called Temozolomide, Procarbazine
Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption.
Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week).
After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.
What is being measured
The primary outcome is the main question the study is designed to answer.
12 month progression free survival
Measured: 3 years
Secondary outcomes (4)
Objective response
MRI review
Measured: 3 years
Toxicity
Utilising NCI CTC v 3.0
Measured: 3 years
Peripheral WBC MGMT modulation
Blood collection and analysis
Measured: 3 years
biomarker correlation with response
using multiplex bioassay analysis
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startNov 2009
- Primary completionNov 2012 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4Studies 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Sydney and Central Coast Area Health Service
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124240
- Sponsor's protocol ID
- 0910259M
- Acronym
- ExCentric
- Status last verified
- Jul 2011
- First submitted
- 13 May 2010
- Last updated
- 26 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 11 Study of Cilengitide in Combination With Concurrent Chemotherapy and Radiotherapy Followed by Protracted Daily Low Dose Temozolomide and Low Dose Procarbazine D1 - 20 in Newly Diagnosed Glioblastoma Without Methylation of the MGMT Promoter Gene
- ClinicalTrials.gov ID
- NCT01124240
- Acronym / sponsor ID
- ExCentric / 0910259M
- Keywords
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Northern Sydney and Central Coast Area Health ServiceUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany
- Study start
- Nov 2009
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 17 May 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.
Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption.
Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week).
After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles.
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 (25 listed)
- Newly diagnosed supratentorial GBM (WHO Grade IV,including GBM subtypes, e.g. gliosarcoma), histopathologically confirmed by central assessment as part of the screening for the CENTRIC trial.
- Males or females ≥18 years of age.
- Proven unmethylated MGMT gene promoter status, centrally assessed as part of the screening for the CENTRIC trial.
- Written informed consent for the present trial obtained before undergoing any study-related activities. The informed consent also allows access to all information obtained during the screening for the CENTRIC trial, notably the result of the MGMT testing.
- Available post-operative Gd-MRI performed within <48 hours after surgery (in case it was not possible to obtain a Gd-MRI within <48 hours post surgery, a Gd-MRI is to be performed prior to randomization).
Key exclusion criteria (20 listed)
- Subjects are not eligible for this study, if they fulfill one or more of the following exclusion criteria:
- Prior chemotherapy within the last 5 years.
- Prior RTX of the head.
- Receiving concurrent investigational agents or has received an investigational agent(s) within the past 30 days prior to the first dose of Cilengitide .
- Prior systemic antiangiogenic therapy.
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 |
|---|---|---|
| CilengitideAlso: Temozolomide, ProcarbazineCilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption. Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week). After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles. | Drug | – |
Primary outcome
12 month progression free survival
Time frame: 3 years
4 secondary outcomes
Objective response
Time frame: 3 years
Toxicity
Time frame: 3 years
Peripheral WBC MGMT modulation
Time frame: 3 years
biomarker correlation with response
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cilengitide in people with Newly Diagnosed Non Methylated Glioblastoma Multiforme Grade 4, run by Northern Sydney and Central Coast Area Health Service at 1 site in Australia.
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 25 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 26 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
12 month progression free survival (time frame: 3 years). 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 26 Jul 2011.