Glioblastoma MultiformePhase 2NCT00800917
A Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
A Phase 2 study testing Temsirolimus and Bevacizumab in people with Glioblastoma Multiforme, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study. 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?
- Temsirolimus and Bevacizumab
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2008to Feb 2010
- 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 GBM and failure after radiotherapy and temozolomide (TMZ)
- Previously treated with VEGF-directed therapy with bevacizumab
- Previously received radiotherapy and temozolomide
- More than 4 weeks since any of the following prior treatments: chemotherapy (6 weeks for nitrosoureas or mitomycin C)
- Radiotherapy to nontarget lesions or lesions that are not to be biopsied VEGF-directed therapy (including bevacizumab)
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- Investigational agents
- More than 6 months since prior major surgery or open biopsy and recovered (only 6 weeks required if operation is for recurrent GBM)
- No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of the following:
- Temsirolimus
- Bevacizumab
- CYP450 isoenzymes
- ECOG performance status 0-1
- WBC ≥ 3,000 mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin and phosphate normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Urine protein: creatinine ratio < 1.0 OR 24-hour urine protein < 1,000 mg
- Fasting cholesterol < 350 mg/dL (cholesterol medications are allowed)
- Fasting triglycerides < 400 mg/dL
- PT INR ≤ 1.5
- Hematocrit < 41% (for males) or < 38% (for females)
- Fertile females must use an approved contraceptive (p-pills, IUD, depot injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal depot plaster), throughout the study and 3 months after discontinuation of study drugs. Fertile men must use dobbelt barrier method (preservative with sperm inhibiting creme) or female partner uses the above mentioned contraceptive.
- Fertile males must use preservatives.
Who cannot join
- Clinically significant cardiovascular disease, including the following:
- Cerebrovascular accident within the past 6 months
- Transient ischemic attack within the past 6 months
- Myocardial ischemia within the past 6 months
- Myocardial infarction within the past 6 months
- Other thromboembolic event within the past 6 months
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- Unstable angina within the past 6 months
- Uncontrolled hypertension (i.e., hypertension despite maximal therapy)
- New York Heart Association class II-IV heart disease
- Congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Clinically significant peripheral vascular disease
- Uncontrolled intercurrent illness
- Ongoing or active infection
- One of the following within the past 6 months
- Abdominal fistula
- Gastrointestinal perforation
- Intra-abdominal abscess
- Serious or nonhealing wound, ulcer, or bone fracture
- Psychiatric illness or social situations that would preclude study compliance
- Uncontrolled diabetes
- Hemoglobin A1c > 7%
- Concurrent non-study related surgical procedures
- Concurrent treatment with CYP3A4 inducers or inhibitors
- Other concurrent anticancer agents or therapies
- Significant traumatic injury within the past 28 days
- History of allergic reactions to compounds of similar chemical or biological composition to temsirolimus or bevacizumab
- Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies (e.g., infliximab)
- Pregnancy or nursing
- Patients previously intolerant to bevacizumab
- Anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study. Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A safety analysis will be performed when the first 10 patients have received minimum 4 cycles (8 weeks). The study will then be stopped:
If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described in the SPC of each agents, If partial remission is not observed in at least 1/10 patients
- Conditions
- Glioblastoma Multiforme
- Being tested
- Temsirolimus, Bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemsirolimusDrug
25 mg weekly IV
BevacizumabDrug
10 mg/kg every 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival in months
Measured: From start of treatment to death or progression
Secondary outcomes (4)
Adverse events
Measured: every 2 weeks
Objective tumor response rate
Measured: every 8 weeks
Pre- vs post-treatment measurements of biomarkers and vascular system/immune system parameters
Measured: weekly for the first 4 weeks, then every 8 weeks
Correlation with biomarkers
Measured: at the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies 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
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Wyeth is now a wholly owned subsidiary of Pfizer, Roche, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800917
- Sponsor's protocol ID
- BEV-CCI-779-GBM-02
- Other IDs
- Eudract no.: 2008-003679-40
- Status last verified
- Apr 2010
- First submitted
- 1 Dec 2008
- Last updated
- 2 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Temsirolimus and Bevacizumab in Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00800917
- Acronym / sponsor ID
- BEV-CCI-779-GBM-02
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Wyeth is now a wholly owned subsidiary of Pfizer, Roche, Copenhagen
- Study start
- Nov 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Dec 2008 (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.
This trial is an investigator initiated, open label phase II study, where patient with recurrent primary GBM will be considered for the study. Only patients with recurrence after Temozolomide and VEGF-directed therapy with Bevacizumab will be considered for the study. Patients will receive temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15 and 22 and bevacizumab 10 mg/kg IV over 30-90 minutes on day 8 and 22. Treatment repeats every 28 days for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. A safety analysis will be performed when the first 10 patients have received minimum 4 cycles (8 weeks). The study will then be stopped:
If DLT is observed in > 2/10 patients, Occurrence of any serious adverse events not described in the SPC of each agents, If partial remission is not observed in at least 1/10 patients
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 (26 listed)
- Written informed consent
- Histological verification of primary GBM and failure after radiotherapy and temozolomide (TMZ)
- Previously treated with VEGF-directed therapy with bevacizumab
- Previously received radiotherapy and temozolomide
- More than 4 weeks since any of the following prior treatments: chemotherapy (6 weeks for nitrosoureas or mitomycin C)
Key exclusion criteria (31 listed)
- Clinically significant cardiovascular disease, including the following:
- Cerebrovascular accident within the past 6 months
- Transient ischemic attack within the past 6 months
- Myocardial ischemia within the past 6 months
- Myocardial infarction within the past 6 months
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 |
|---|---|---|
| Temsirolimus25 mg weekly IV | Drug | – |
| Bevacizumab10 mg/kg every 2 weeks | Drug | – |
Primary outcome
Progression-free survival in months
Time frame: From start of treatment to death or progression
4 secondary outcomes
Adverse events
Time frame: every 2 weeks
Objective tumor response rate
Time frame: every 8 weeks
Pre- vs post-treatment measurements of biomarkers and vascular system/immune system parameters
Time frame: weekly for the first 4 weeks, then every 8 weeks
Correlation with biomarkers
Time frame: at the end of the 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 2 Jun 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Temsirolimus and Bevacizumab in people with Glioblastoma Multiforme, run by Copenhagen University Hospital, Rigshospitalet at 1 site 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 26 inclusion and 31 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 2 Jun 2010. 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 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 in months (time frame: From start of treatment to death or progression). 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 2 Jun 2010.