Giant Cell GlioblastomaPhase 2NCT01149850
Bevacizumab and Temozolomide in Treating Older Patients With Newly-Diagnosed Glioblastoma Multiforme or Gliosarcoma
A Phase 2 study testing bevacizumab, temozolomide and laboratory biomarker analysis in people with Giant Cell Glioblastoma and Glioblastoma, run by Jonsson Comprehensive Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma
- What is being tested?
- bevacizumab, temozolomide and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2010to 8 Dec 2023
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS); this includes treatment-naive patients with prior tissue diagnosis of lower grade gliomas that have been upgraded after repeat resection
- Cranial MRI or contrast CT must have been performed within 21 days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed within 96 hours of resection is preferred, but not required; patients without measureable or assessable disease are eligible
- Patients must begin temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than 4 weeks and no later than 6 weeks from the surgery
- Patients must be willing to forego other drug therapy against the tumor while being treated with bevacizumab and temozolomide
- All patients must sign and informed consent approved by the Institutional Review Board indicating that they are aware of the investigational nature of this study; patients must also sign an authorization for the release of their protected heath information
- Life expectancy > 8 weeks
Show all 14Show fewer
- Patients must have a Karnofsky performance status of >= 60
- WBC >= 3,000/ul
- ANC >= 1,500/mm^3
- Platelet count of >= 100,000/mm^3
- Hemoglobin >= 10 gm/dl
- SGOT < 2.5 times ULN
- Bilirubin < 2.5 ULN
- Patients must have adequate renal function (creatinine < 1.5 mg/dL) before starting therapy and the test must be performed within 14 days prior to registration
Who cannot join
- Glioblastoma disease-specific concerns: Patients must not have received previous or concurrent radiotherapy to the brain
- Glioblastoma disease-specific concerns: Patients must have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, AED's, analgesics, and other drugs to treat symptoms or prevent complications
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Patients with a history of any other cancer (except non-melanoma skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible
- Patients receiving current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin) are NOT excluded
- Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
Show all 25Show fewer
- Patients must not have serious uncontrolled inter-current medical illness including, but not limited to, ongoing or active infection requiring IV antibiotics, psychiatric illness/social situations that would limit compliance with study requirements, or disorders associated with significant immunocompromised state (HIV, SLE, etc.)
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
- Blood pressure of > 150/100 mmHg, history of hypertensive crisis or hypertensive encephalopathy
- Unstable angina
- New York Heart Association (NYHA) Grade II or greater congestive heart failure
- History of myocardial infarction within 6 months prior to day 1
- History of stroke within 6 months prior to day 1
- International normalized ratio (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x the ULN (except for subjects receiving anticoagulation therapy) in the absence of therapeutic intent to anticoagulate the subject; therapeutic anticoagulation is permitted
- Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis ( >= 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
- Major surgical procedure, open biopsy, or significant traumatic injury other than craniotomy within 28 days prior to Day 1, anticipation of need for major surgical procedure during the course of the study
- Minor surgical procedures such as placement of Port-a-Cath, stereotactic biopsy, fine needle aspirations, or core biopsies within 7 days prior to Day 1
- History of intracerebral abscess within 6 months prior to Day 1
- Urine protein: creatinine ratio >= 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1
- Serious, non-healing wound, ulcer, or bone fracture; patients with any wound requiring surgical intervention (including scalp wounds requiring cranioplasty) will be allowed to resume the study if the wound is clean and without further infection post-surgical intervention
- Known hypersensitivity to any component of bevacizumab
- Inability to comply with study and/or follow-up procedures
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Kaiser Foundation Hospital
Los Angeles, California, 90027
University of California, Los Angeles
Los Angeles, California, 90095
Kaiser Permanente at San Diego
San Diego, California, 92120
About this study
Official title: Phase II Study of Bevacizumab and Temozolomide in Elderly Patients With Newly-Diagnosed Glioblastoma
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as temozolomide, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with temozolomide may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying how well giving bevacizumab and temozolomide together works in treating older patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate overall survival in elderly subjects treated with bevacizumab and temozolomide for newly diagnosed glioblastoma multiforme.
SECONDARY OBJECTIVES:
- To estimate 12-months survival. II. To estimate progression free survival for 2 years or until progression is detected.
III. To investigate the safety and tolerability of bevacizumab/temozolomide in elderly patient with glioblastoma.
IV. To isolate DNA, RNA, and protein isolated from frozen and paraffinized archival tumor samples for evaluations such as immunohistochemical pathway profiling of VEGF-dependent angiogenic pathways, gene expression microarray, and MGMT promoter methylation status to define important molecule features of treatment response and especially age-related molecular expression.
OUTLINE:
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks and oral temozolomide on days 1-5. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at least every 4 months.
- Conditions
- Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma
- Being tested
- bevacizumab, temozolomide, laboratory biomarker analysis, immunohistochemistry staining method, microarray analysis
- Keywords
- adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
- Medical subject headings
- Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, anti-VEGF rhuMAb, Avastin
Given IV
temozolomideDrug
Also called CCRG-81045, M & B 39831, SCH 52365, Temodal
Given orally
laboratory biomarker analysisOther
Correlative studies
immunohistochemistry staining methodOther
Also called immunohistochemistry
Correlative studies
microarray analysisGenetic
Also called gene expression profiling
Correlative studies
DNA methylation analysisGenetic
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive bevacizumab IV over 30-90 minutes every 2 weeks and oral temozolomide on days 1-5. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. Receives: Biological: bevacizumab; Drug: temozolomide; Other: laboratory biomarker analysis; Other: immunohistochemistry staining method; Genetic: microarray analysis; Genetic: DNA methylation analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Pts who progress followed for survival every 4 mths.Pts completing therapy \& no progression followed every 2 mths/12 mths,every 3 mths/12 mths,every 4 mths/12 mths,every 6 mths until progression,then followed every 4 mths for survival
Measured: 2 years
Secondary outcomes (2)
Time to progression
Pts who progress followed for survival every 4 mths.Pts completing therapy \& no progression followed every 2 mths/12 mths,every 3 mths/12 mths,every 4 mths/12 mths,every 6 mths until progression.
Measured: 2 years
progression free survival
Patients completing therapy \& no progression followed every 2 mths/12 mths,every 3 mths/12 mths,every 4 mths/12 mths,every 6 mths until progression,then followed every 4 mths for survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study start28 Apr 2010
- Primary completion8 Dec 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell GlioblastomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Phioanh Nghiemphu, Principal investigator, University of California at Los Angeles (UCLA )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149850
- Sponsor's protocol ID
- 10-000760
- Other IDs
- AVF4535s, 09-06-032
- Status last verified
- Feb 2024
- First submitted
- 22 Jun 2010
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bevacizumab and Temozolomide in Elderly Patients With Newly-Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT01149850
- Acronym / sponsor ID
- 10-000760
- Conditions
- Giant Cell Glioblastoma, Glioblastoma, Gliosarcoma
- Keywords
- adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 28 Apr 2010 (actual)
- Primary completion
- 8 Dec 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 24 Jun 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.
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as temozolomide, also work in different ways to kill tumor cells or stop them from growing. Giving bevacizumab together with temozolomide may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying how well giving bevacizumab and temozolomide together works in treating older patients with newly diagnosed glioblastoma multiforme or gliosarcoma.
Detailed description
PRIMARY OBJECTIVES:
- To estimate overall survival in elderly subjects treated with bevacizumab and temozolomide for newly diagnosed glioblastoma multiforme.
SECONDARY OBJECTIVES:
- To estimate 12-months survival. II. To estimate progression free survival for 2 years or until progression is detected.
III. To investigate the safety and tolerability of bevacizumab/temozolomide in elderly patient with glioblastoma.
IV. To isolate DNA, RNA, and protein isolated from frozen and paraffinized archival tumor samples for evaluations such as immunohistochemical pathway profiling of VEGF-dependent angiogenic pathways, gene expression microarray, and MGMT promoter methylation status to define important molecule features of treatment response and especially age-related molecular expression.
OUTLINE:
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks and oral temozolomide on days 1-5. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at least every 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: bevacizumab, Drug: temozolomide, Other: laboratory biomarker analysis, Other: immunohistochemistry staining method, Genetic: microarray analysis, Genetic: DNA methylation analysisPatients receive bevacizumab IV over 30-90 minutes every 2 weeks and oral temozolomide on days 1-5. Treatment repeats every 28 days for 24 courses in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- Patients will have histologically proven intracranial glioblastoma multiforme (GBM) or gliosarcoma (GS); this includes treatment-naive patients with prior tissue diagnosis of lower grade gliomas that have been upgraded after repeat resection
- Cranial MRI or contrast CT must have been performed within 21 days of study entry; the use of MRI rather than CT is preferred; the same type of scan, i.e., MRI or CT, must be used throughout the period of protocol treatment for tumor measurement; if the surgical procedure was a resection, cranial MRI or contrast CT performed within 96 hours of resection is preferred, but not required; patients without measureable or assessable disease are eligible
- Patients must begin temozolomide chemotherapy no sooner than 2 weeks and no later than 6 weeks from the diagnostic surgery; patients must begin bevacizumab no sooner than 4 weeks and no later than 6 weeks from the surgery
- Patients must be willing to forego other drug therapy against the tumor while being treated with bevacizumab and temozolomide
- All patients must sign and informed consent approved by the Institutional Review Board indicating that they are aware of the investigational nature of this study; patients must also sign an authorization for the release of their protected heath information
Key exclusion criteria (25 listed)
- Glioblastoma disease-specific concerns: Patients must not have received previous or concurrent radiotherapy to the brain
- Glioblastoma disease-specific concerns: Patients must have received cytotoxic drug therapy, non-cytotoxic drug therapy, or experimental drug therapy directed against the brain tumor; patients who received Gliadel wafers will be excluded; patients may have received or be receiving corticosteroids, AED's, analgesics, and other drugs to treat symptoms or prevent complications
- Patients must not have any significant medical illnesses that in the investigator's opinion cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy
- Patients with a history of any other cancer (except non-melanoma skin cancer, carcinoma in-situ of the cervix, or low-risk prostate cancer after curative therapy), unless in complete remission and off of all therapy for that disease for a minimum of 3 years are ineligible
- Patients receiving current, ongoing treatment with full-dose warfarin or its equivalent (i.e., unfractionated and/or low molecular weight heparin) are NOT excluded
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 |
|---|---|---|
| bevacizumabAlso: anti-VEGF humanized monoclonal antibody, anti-VEGF monoclonal antibody, anti-VEGF rhuMAb, AvastinGiven IV | Biological | Arm I |
| temozolomideAlso: CCRG-81045, M & B 39831, SCH 52365, TemodalGiven orally | Drug | Arm I |
| laboratory biomarker analysisCorrelative studies | Other | Arm I |
| immunohistochemistry staining methodAlso: immunohistochemistryCorrelative studies | Other | Arm I |
| microarray analysisAlso: gene expression profilingCorrelative studies | Genetic | Arm I |
| DNA methylation analysisCorrelative studies | Genetic | Arm I |
Primary outcome
Overall survival
Time frame: 2 years
Pts who progress followed for survival every 4 mths.Pts completing therapy \& no progression followed every 2 mths/12 mths,every 3 mths/12 mths,every 4 mths/12 mths,every 6 mths until progression,then followed every 4 mths for survival
2 secondary outcomes
Time to progression
Time frame: 2 years
progression free survival
Time frame: 2 years
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 19 Sep 2024.
Related trials for Giant Cell Glioblastoma
RecruitingPhase 1
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
Neoplasms, Brain, Glioblastoma Multiforme
Active, not recruitingPhase 4
Pediatric Long-Term Follow-up and Rollover Study
Diffuse Astrocytoma, Anaplastic Astrocytoma
Active, not recruitingPhase 1
Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas
Adult Anaplastic Astrocytoma, Adult Anaplastic Oligodendroglioma
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.
Phioanh Nghiemphu principal investigator
University of California at Los Angeles (UCLA )
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, temozolomide and laboratory biomarker analysis in people with Giant Cell Glioblastoma and Glioblastoma, run by Jonsson Comprehensive Cancer Center at 3 sites 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 14 inclusion and 25 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 19 Sep 2024. 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 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?
Overall survival (time frame: 2 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 19 Sep 2024.