Brain NeoplasmsPhase 2NCT00463203
Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy
A Phase 2 study testing Bevacizumab and Irinotecan in people with Brain Neoplasms and Glioma, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
Trial summary
Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Glioma
- What is being tested?
- Bevacizumab and Irinotecan
- How many people
- 54 participants
- Where
- 3 sitesDenmark
- Study dates
- Mar 2007to 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
- Written informed consent
- Histological verification of primary malignant brain tumor, or grade II glioma, meningeoma or ependymoma with progression and no other treatment options (including brain stem gliomas without histological verification)
- Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and for grade III or IV tumors temozolomide or other chemotherapy.
- Evidence of measurable recurrent progressive disease (CT/MRI scan)
- An interval of at least 4 weeks between prior surgical resection and study enrollment
- An interval of at least 4 weeks between prior radiotherapy or chemotherapy and enrollment on this protocol.
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- PS 0-2 (ECOG scale)
- Age > 18
- Life expectancy > 3 month
- Normal organ function:
- Platelets > 125 x 109/l
- Hemoglobin >6,2 mmol/l
- Leukocytes > 3 x 109/l
- ACN> 1,5 x 109/l
- ASAT or ALAT < 3 x upper normal limit
- Bilirubin < 1,5 x upper normal limit
- Creatinine clearance > 45 ml/min
- APTT < normal limit
- INR < normal limit
- Fertile females must use oral contraceptive, IUD (intrauterine device), gestagen sustained release injection, subdermal implantation, transdermal patch or hormonal vaginal ring. This must continue at least three months after the patients is off-study. Fertile males must use preservatives
- No sign of cerebral bleeding
Who cannot join
- Radiotherapy or chemotherapy within the last 4 weeks.
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
- Prior VEGF-based therapy
- Any condition (medical, social, psychological), which would prevent adequate information and follow-up
- Any other concurrent active malignancy, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
- Any significant cardiac disease (New York Heart Association Class II or greater), arrhythmia, congestive heart failure, acute myocardial infarction within 6 months or unstable angina pectoris.
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- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis, coagulopathy or taking ASA, NSAIDs or clopidogrel
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 0, anticipation of need for major surgical procedure during the curse of the study
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 month prior to day 0
- History of known HIV, Hepatitis B and Hepatitis C negative
- Any ongoing infection, uncontrolled diabetes mellitus, serious non-healing wound, ulcer or bone fracture
- Pregnancy or breast feeding
- Requires therapeutic anti-coagulation
- Blood pressure > 150/100 mmHG
- Grade 2 or greater proteinuria
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Aalborg University Hospital
Aalborg, 9000
Rigshospitalet
Copenhagen, 2100
Odense University Hospital
Odense, 5000
About this study
Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas.
Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.
- Conditions
- Brain Neoplasms, Glioma
- Being tested
- Bevacizumab, Irinotecan
- Keywords
- primary malignant brain tumor, grade II glioma, meningeoma, ependymoma, Recurrence or progression after standard treatment
- Medical subject headings
- Brain Neoplasms, Glioma, Ependymoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
10 mg/kg every 2 weeks
IrinotecanDrug
125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: 6 months
Secondary outcomes (2)
Response rate - Response according to MacDonald criteria
Measured: 6 months
Adverse event according to CTCAE 3.0
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Ulrik Lassen, MD., PH.D., Principal investigator, Rigshospitalet, Dept. of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00463203
- Sponsor's protocol ID
- BI-Brain-01
- Status last verified
- Jun 2011
- First submitted
- 18 Apr 2007
- Last updated
- 29 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab and Irinotecan for Patients With Primary Brain Tumors and Progression After Standard Therapy
- ClinicalTrials.gov ID
- NCT00463203
- Acronym / sponsor ID
- BI-Brain-01
- Conditions
- Brain Neoplasms, Glioma
- Keywords
- primary malignant brain tumor, grade II glioma, meningeoma, ependymoma, Recurrence or progression after standard treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Apr 2007 (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.
Irinotecan has demonstrated activity in malignant gliomas in multiple phase II studies. The activity is limited, with an approximately 15 % response rate and a progression-free survival of 3-5 months. Given the synergy between irinotecan and bevacizumab in colorectal cancer, and the high-level expression of vascular endothelial growth factor on malignant gliomas, one would expect synergy between bevacizumab and irinotecan against gliomas.
Recent data form a small study of 32 patients from Duke University have achieved a response rate of 62% in patients with malignant gliomas. Most included patients had glioblastomas, but this regimen may also have activity in more rare primary malignant brain tumors. The investigators therefore plan to include other primary malignant brain tumors in this study, and the clinical activity will be correlated with biomarkers and PET results of metabolic activity and blood flow. This may result in information that can be used to individualize therapy in the future.
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 (21 listed)
- Written informed consent
- Histological verification of primary malignant brain tumor, or grade II glioma, meningeoma or ependymoma with progression and no other treatment options (including brain stem gliomas without histological verification)
- Recurrence or progression after standard treatment (debulking surgery of possible, radiotherapy and for grade III or IV tumors temozolomide or other chemotherapy.
- Evidence of measurable recurrent progressive disease (CT/MRI scan)
- An interval of at least 4 weeks between prior surgical resection and study enrollment
Key exclusion criteria (17 listed)
- Radiotherapy or chemotherapy within the last 4 weeks.
- Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids
- Prior VEGF-based therapy
- Any condition (medical, social, psychological), which would prevent adequate information and follow-up
- Any other concurrent active malignancy, except, adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ.
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 |
|---|---|---|
| Bevacizumab10 mg/kg every 2 weeks | Drug | – |
| Irinotecan125 mg/m2 non-EIAED or 340 mg/m2 EIAED every 2 weeks | Drug | – |
Primary outcome
progression-free survival
Time frame: 6 months
2 secondary outcomes
Response rate - Response according to MacDonald criteria
Time frame: 6 months
Adverse event according to CTCAE 3.0
Time frame: 6 months
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 29 Jun 2011.
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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.
Ulrik Lassen, MD., PH.D. principal investigator
Rigshospitalet, Dept. of Oncology
3 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 Bevacizumab and Irinotecan in people with Brain Neoplasms and Glioma, run by Copenhagen University Hospital, Rigshospitalet at 3 sites in Denmark.
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 21 inclusion and 17 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 29 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
progression-free survival (time frame: 6 months). 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 29 Jun 2011.