Recurrent Glioblastoma MultiformePhase 2NCT00883298
Bi-weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
A Phase 2 study testing temozolomide and bevacizumab in people with Recurrent Glioblastoma Multiforme and Recurrent Gliosarcoma, run by Center for Neurosciences, Tucson at 1 site in United States.
Trial summary
Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bevacizumab. Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Recurrent Glioblastoma Multiforme, Recurrent Gliosarcoma
- What is being tested?
- temozolomide and bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 1 Dec 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 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed diagnosis of a glioblastoma multiforme/gliosarcoma and:
- Must have completed at least 2 cycles of adjuvant chemotherapy
- Age > 18 years
- Karnofsky > 60%
- Hematocrit > 29%, ANC > 1,500 cells/dl, platelets > 125,000 cells/dl
- Serum creatinine < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal
Show all 9Show fewer
- If on corticosteroids, must be on a stable dose for 1 week prior to entry; if clinically possible, the dose should not be escalated over entry dose level
- Signed informed consent approved by the Institutional Review Board prior to study entry
- If sexually active, will take contraceptive measures for the duration of the treatments
Who cannot join
- Prior toxicity grade ≥ 3 with TMZ
- Prior treatment with bevacizumab
- Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
- Acute or chronic liver disease (i.e., hepatitis, cirrhosis)
- Confirmed diagnosis of HIV infection
Show all 32Show fewer
- Have received investigational drugs less than 4 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy
- Have received chemotherapy within 2 weeks prior (6 weeks for nitrosourea) to entry on this study, or who have not recovered from the toxic effects of such therapy
- Have received biologic, immunotherapeutic or cytostatic agents within 1 week prior to entry on this study or who have not recovered from the toxic effects of such therapy
- Less than 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant
- Have received radiation therapy within 2 weeks prior to entry on this study or who have not recovered from the toxic effects of such therapy.
- Surgical resection of brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- Have had any surgery other than resection of a brain tumor within 4 weeks prior to entry on this study or who have not recovered from side effects of such therapy
- Unwilling to or unable to comply with the protocol
- Evidence of tumor progression within on immediate post radiation brain imaging
- Have not received at least 2 cycles of adjuvant chemotherapy
- Life expectancy of less than 12 weeks
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- Bevacizumab-Specific Exclusions:
- Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
- History of myocardial infarction or unstable angina within 6 months
- History of stroke or transient ischemic attack within 6 months
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during the course of the study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture.
- Proteinuria as demonstrated by a UPC ratio greater than or equal to 1.0 at screening
- Known hypersensitivity to any component of bevacizumab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bevacizumab.
Secondary objectives - to determine radiographic response including specialized MRI sequences, safety and overall survival of adult patients with with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin). Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.
Read the detailed description
This is a phase II study of the combination of Avastin and temozolomide for patients with recurrent glioblastoma multiforme. Avastin is administered intravenously at a dose of 10 mg/kg on days 1 and 15 every 28 days and temozolomide is administered at a dose of 100 mg/m2 on days 1-5 and 15-19 every 28 days (one cycle). Patients will have a baseline MRI, an MRI scan after the first cycle and every other cycle after that. If there is no evidence of disease progression or unacceptable toxicity, patients will receive one year of therapy. If there is evidence of added benefit (eg: tumor regression), patients can stay on treatment longer than one year, per investigator discretion.
- Being tested
- temozolomide and bevacizumab
- Keywords
- temozolomide, bevacizumab, Temodar, Avastin, glioblastoma multiforme, gliosarcoma, glioma, GBM, brain tumor
- Medical subject headings
- Glioblastoma, Gliosarcoma, Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temozolomide and bevacizumabDrug
Also called Temodar, Avastin
oral temozolomide 100 mg/m2 days 1-5 \& 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 \& 5 every 28-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | temozolomide plus bevacizumab administered as open label single arm treatment Receives: Drug: temozolomide and bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month progression-free survival.
Measured: 6 months
Secondary outcomes (3)
Radiographic response (Gd-MRI) including specialized MRI sequences (T2/FLAIR).
Measured: every eight weeks
Incidence and severity of toxicity.
Measured: 6 months
Tumor DNA (MGMT) analysis as it relates to survival.
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 posted17 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2014
- Study completion1 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Glioblastoma MultiformeStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Neurosciences, Tucson
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Michael Badruddoja, MD, Center for Neurosciences, Tucson
- Investigators
- Michael A. Badurddoja, MD, Principal investigator, Center for Neurosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00883298
- Sponsor's protocol ID
- AVF4514s
- Status last verified
- Mar 2017
- First submitted
- 16 Apr 2009
- Last updated
- 30 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bi-Weekly Temozolomide Plus Bevacizumab for Adult Patients With Recurrent Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00883298
- Acronym / sponsor ID
- AVF4514s
- Keywords
- temozolomide, bevacizumab, Temodar, Avastin, glioblastoma multiforme, gliosarcoma, glioma, GBM
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Center for Neurosciences, TucsonUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Apr 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- 1 Dec 2014 (actual)
- First posted
- 17 Apr 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.
Primary objective - to determine the 6-month progression free survival (PFS) of adult patients with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus (Avastin) bevacizumab.
Secondary objectives - to determine radiographic response including specialized MRI sequences, safety and overall survival of adult patients with with recurrent glioblastoma multiforme/gliosarcoma treated with bi-weekly temozolomide plus bevacizumab (Avastin). Additionally, tumor DNA (MGMT) analysis as it relates to survival will be evaluated.
Detailed description
This is a phase II study of the combination of Avastin and temozolomide for patients with recurrent glioblastoma multiforme. Avastin is administered intravenously at a dose of 10 mg/kg on days 1 and 15 every 28 days and temozolomide is administered at a dose of 100 mg/m2 on days 1-5 and 15-19 every 28 days (one cycle). Patients will have a baseline MRI, an MRI scan after the first cycle and every other cycle after that. If there is no evidence of disease progression or unacceptable toxicity, patients will receive one year of therapy. If there is evidence of added benefit (eg: tumor regression), patients can stay on treatment longer than one year, per investigator discretion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: temozolomide and bevacizumabtemozolomide plus bevacizumab administered as open label single arm treatment |
Who may qualify
- Ages
- 18 to 83 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must have histologically confirmed diagnosis of a glioblastoma multiforme/gliosarcoma and:
- Must have completed at least 2 cycles of adjuvant chemotherapy
- Age > 18 years
- Karnofsky > 60%
- Hematocrit > 29%, ANC > 1,500 cells/dl, platelets > 125,000 cells/dl
Key exclusion criteria (32 listed)
- Prior toxicity grade ≥ 3 with TMZ
- Prior treatment with bevacizumab
- Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control
- Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
- Acute or chronic liver disease (i.e., hepatitis, cirrhosis)
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 and bevacizumabAlso: Temodar, Avastinoral temozolomide 100 mg/m2 days 1-5 \& 15-19 every 28-day cycle plus intravenous bevacizumab 10 mg/kg days 1 \& 5 every 28-day cycle | Drug | Open Label |
Primary outcome
6-month progression-free survival.
Time frame: 6 months
3 secondary outcomes
Radiographic response (Gd-MRI) including specialized MRI sequences (T2/FLAIR).
Time frame: every eight weeks
Incidence and severity of toxicity.
Time frame: 6 months
Tumor DNA (MGMT) analysis as it relates to survival.
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 30 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Recurrent Glioblastoma Multiforme
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
RecruitingObservational study
Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme
Glioblastoma Multiforme
Active, not recruitingPhase 3
Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM
Glioblastoma, Recurrent Glioblastoma
RecruitingPhase 1
A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma
Glioblastoma Multiforme of Brain, Glioma
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 A. Badurddoja, MD principal investigator
Center for Neurosciences
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 temozolomide and bevacizumab in people with Recurrent Glioblastoma Multiforme and Recurrent Gliosarcoma, run by Center for Neurosciences, Tucson at 1 site in United States.
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 9 inclusion and 32 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 30 Mar 2017. 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 United States. 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?
6-month 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 30 Mar 2017.