Glioblastoma MultiformePhase 2NCT00590681
Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme
A Phase 2 study testing Bevacizumab and Temozolomide in people with Glioblastoma Multiforme, run by University of Chicago at 5 sites in United States.
Trial summary
This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. 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?
- Bevacizumab and Temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2007to Sep 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Disease-Specific Concerns Histologically confirmed GBM as determined by central pathology review Supratentorial location
- General Medical Concerns 18 years of age; Karnofsky performance status > 60; Tumor-related contrast enhancement on initial and post-operative Gd-MRI; Recovery from effects of surgery and/or its complications prior to initiating radiotherapy; Radiotherapy must begin < 5 weeks following surgery; Pre-and post-operative Gd-MRI prior to the initiation of radiotherapy; Adequate hematological, renal, and hepatic function:hemoglobin > 10 grams hematocrit > 30%, platelets > 100,000 per mm3, BUN < 25 mg/dl, Creatinine < 1.5 mg/dl, Total bilirubin < 1.5 mg/dl, SGOT or SGPT < twice institutional normal range, Subjects must not be pregnant or nursing, Use of effective means of contraception (men and women) in subjects of child-bearing (women) and at all ages (men), Study-specific signed informed consent, Ability to comply with study follow-up procedures.
- -
Who cannot join
- a. Disease-Specific Concerns: malignant gliomas graded less than GBM; infratentorial tumor location; recurrent disease; intra-tumoral hemorrhage; Placement of Gliadel® wafers; b. Bevacizumab-Specific Concerns: Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications); Any prior history of hypertensive crisis or hypertensive encephalopathy; History of myocardial infarction or unstable angina within 6 months prior to study enrollment; History of stroke or transient ischemic attack within 6 months prior to study enrollment; New York Heart Association (NYHA) Grade II or greater CHF (see Appendix E); Significant vascular disease (e.g., aortic aneurysm, aortic dissection); Symptomatic peripheral vascular disease; Evidence of bleeding diathesis or coagulopathy; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment; History of intracerebral abscess within 6 months prior to study enrollment; Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment (exclusive of craniotomy); 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 prior to study enrollment; Serious non-healing wound, ulcer, or bone fracture; Proteinuria at screening as demonstrated by either; Urine protein:creatinine (UPC) ratio 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible); Known hypersensitivity to any component of Avastin. c. General Medical Exclusions
- Subjects meeting any of the following criteria are ineligible for study entry:
- 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 Avastin cancer study; History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix);Pregnant or nursing females; Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmias requiring medication;
- Screening clinical laboratory values:
- Absolute neutrophil count < 1500/ul, Platelet count < 100,000/ul, Total bilirubin > 1.6 mg.dl, AST/ALT > 1.5 x the upper limit of normal ( ULN), Creatinine > 1.2 x ULN, Urine protein/creatinine ratio > 1.0, International normalized ration (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x ULN (except for subjects receiving anticoagulation therapy) in the absence of therapeutic intent to anticoagulate the subject. Therapeutic anticoagulation is permitted.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48103
The University of Chicago
Chicago, Illinois, 60637
NorthShore University health system
Evanston, Illinois, 60201
Medical college of Wisconsin
Milwaukee, Wisconsin, 53226
Waukesha health care
Waukesha, Wisconsin, 53188
About this study
Official title: Avastin and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme: A Phase II Study
This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin.
Avastin is the experimental drug being administered in this research study. Avastin binds a protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and circulates in the blood. One of VEGF's main roles is to support the growth of new blood vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from functioning. In laboratory studies, Avastin prevented the growth of several different types of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy. Avastin has not been approved by the FDA for the treatment of GBM and is, therefore, considered experimental. Avastin is currently undergoing testing (alone and in combination with another anti-cancer drug, irinotecan) in persons with GBM that have come back after conventional treatment.
Read more
Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of cells (including cancer cells) by stopping their division. Temozolomide was approved by the U.S. FDA for the treatment of newly diagnosed GBM in 2005.
Avastin and temozolomide are currently being used together in several research studies involving people with newly diagnosed GBM. Limited information is available about either the safety or effectiveness of this drug combination.
Read the detailed description
The study consists of the following: 1) a screening period of up to 28 days; 2) a treatment period of radiation with daily temozolomide that lasts approximately 6 weeks, 3) a study treatment period that will last until either your tumor grows or you experience unacceptable side effects; and 4) a 30-day follow-up period after treatment has ended. Additionally, basic information concerning your condition will be collected every 2 months after the follow-up period for the rest of your life.
During this study, Dr. Nicholas and his research team will collect information about you for the purposes of this research. This includes name, address, dates (i.e., date of birth, date of consent), telephone number, and medical record number. Slides of your tumor tissue that were used to diagnose your GBM will be sent to a pathologist to confirm the diagnosis of GBM. After this review has been completed your slides will be returned to the hospital that provided them. Preserved samples of your tumor will also be sent for a test to determine how effective the temozolomide might be in your case. Any remaining tissue will be returned to the hospital that provided it.
Screening phase (following diagnosis of GBM at surgery) To determine if you are eligible to participate in this study, you will undergo a screening process that will involve the following
- Assessment of your cancer by magnetic resonance imaging (MRI) of your brain using an intravenous (in your vein) contrast material
- Recording of your general medical, surgical and cancer history
- Physical examination, including measurement of your blood pressure, height and weight
- Evaluation of your performance status (your ability to carry on daily activities)
- Neurologic examination (how well your nerves and muscles work)
- Blood sample for laboratory tests (approximately 2 to 3 tablespoons) to evaluate your blood counts, liver, and kidney function
- Serum pregnancy test if you are a woman of childbearing potential
- Urine sample
- Recording of any medications taken within the past 14 days
Radiation and daily temozolomide chemotherapy You will begin radiation treatment within 5 weeks of surgery. You will take temozolomide orally once daily (seven days a week) during radiation treatments (which occur Monday - Friday and last approximately six weeks). You will take a medication to prevent a rare form of pneumonia (pneumocystis carinii) that can occur when temozolomide is given on a daily basis. That may be either in pill form or inhaled. During radiation treatment you will be seen every two weeks by a study doctor at which time you will be asked how you are tolerating the treatment. A physical examination, (including neurological evaluation), will be performed. Blood tests (1-2 tablespoons) will be performed to assure that you are not having any side-effects from the chemotherapy.
Post-radiation treatment Two to four weeks after completing radiation you will have a brain MRI scan. Beginning four weeks after radiation ends, the study drug and temozolomide will begin. The study drug (Avastin) will be administered by IV infusion (through a vein) every 2 weeks. Temozolomide will be taken orally for five consecutive days of every 28 days. In other words, you will receive two intravenous infusions of Avastin and five days of temozolomide every 28 days. This constitutes a treatment cycle. These cycles will continue indefinitely. The dose of Avastin will be based upon your weight during screening and will remain the same throughout the study. The temozolomide dose during radiation will be based on your height and weight at screening. During the study phase, temozolomide will be dosed according to your height and weight at the beginning of each treatment cycle. The dose may be delayed for up to four weeks if your blood counts are low. If temozolomide still cannot be given because your blood counts are low for longer than four weeks, the temozolomide will be stopped but the Avastin may still be continued.
Your first dose of Avastin will be given as over 90 minutes. If you tolerate the 90 minute infusion well, infusions in the future may be given over a shorter period of time. However, if you do not tolerate the shorter infusion time, future infusions will be given over the longer period that you previously tolerated. If you experience any problems during or following the infusion, you will be monitored by trained staff until it is considered safe for you to leave.
The dose of Avastin that you receive may be stopped or slowed based on how well you tolerate the treatment. If you must stop treatment because of unfavorable side effects, you may be able to restart treatment once the side effect has improved or resolved. Your doctor will discuss with you whether it is in your best interest to continue treatment. If you stop study drug treatment, you should continue to return to be evaluated as explained below.
Temozolomide will be taken at bedtime on an empty stomach (at least 2 hours after any meal). Prior to each dose of temozolomide, you will take an anti-nausea pill (ondansetron, granisetron, or dolasetron) to reduce nausea and vomiting.
The treatment cycles described above will continue until: 1) your tumor grows, 2) you have unacceptable side effects, 3) you choose to withdraw from this research study, or 4) your participation is ended by Dr. Nicholas or Genentech.
During the first treatment day of each 28 day cycle you will receive Avastin. Your blood pressure will be monitored, and you will have a physical examination, a neurologic examination, and an evaluation of your performance status (how well you are functioning in daily activities). On the same day, you will begin temozolomide chemotherapy. You will have a blood sample drawn for laboratory tests (approximately 2-3 tablespoons), and a urine sample taken. You will be asked by the study doctor about any health problems you have and medications you take. Additional blood samples may be drawn at the discretion of your doctor as part of your standard care.
On day 14 of every treatment cycle you will return to the clinic to receive an infusion of Avastin. At that time, your blood pressure will be taken, and you will have a physical examination and an evaluation of your performance status. On day 21 of each cycle you will have blood work (1-2 tablespoons) to see how well you are tolerating the treatment. Every 8 weeks (after every 2 cycles immediately prior to your next cycle) you will have an MRI of your brain to determine measurements of your tumor.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Bevacizumab and Temozolomide
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab and TemozolomideDrug
Also called Avastin
This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days).
| Study group | Role | What they receive |
|---|---|---|
| one | Experimental | This is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days). Receives: Drug: Bevacizumab and Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response
The best clinical response rates determined and 95% confidence intervals obtained using the exact binomial distribution.
Measured: Up to 3 years
Progression-free Survival (PFS)
Measured: Up to 3 years
Secondary outcomes (4)
Safety of Avastin in Combination With Temozolomide in This Study Population
Toxicity rates (limited toxicity to grade 4+)
Measured: Up to 3 years
Duration of Response
Duration of response time from the first assessment of CR or PR until disease progression or death from any cause, whichever occurs first, event-free survival probability at two years assessed by Kaplan-Meier survivor function
Measured: Up to 2 years
Overall Survival
Measured: Up to 3 years
Changes in Relative Cerebral Blood Volume (rCBV) of Tumors After (2 Infusions) of Avastin
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Martin Kelly Nicholas, MD PhD, Principal investigator, University of ChicagoMartin Kelly Nicholas, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00590681
- Sponsor's protocol ID
- 15149A
- Status last verified
- Mar 2021
- First submitted
- 26 Dec 2007
- Last updated
- 30 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avastin and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme: A Phase II Study
- ClinicalTrials.gov ID
- NCT00590681
- Acronym / sponsor ID
- 15149A
- Conditions
- Glioblastoma Multiforme
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Feb 2007
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 1 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin.
Avastin is the experimental drug being administered in this research study. Avastin binds a protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and circulates in the blood. One of VEGF's main roles is to support the growth of new blood vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from functioning. In laboratory studies, Avastin prevented the growth of several different types of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy. Avastin has not been approved by the FDA for the treatment of GBM and is, therefore, considered experimental. Avastin is currently undergoing testing (alone and in combination with another anti-cancer drug, irinotecan) in persons with GBM that have come back after conventional treatment.
Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of cells (including cancer cells) by stopping their division. Temozolomide was approved by the U.S. FDA for the treatment of newly diagnosed GBM in 2005.
Avastin and temozolomide are currently being used together in several research studies involving people with newly diagnosed GBM. Limited information is available about either the safety or effectiveness of this drug combination.
Detailed description
The study consists of the following: 1) a screening period of up to 28 days; 2) a treatment period of radiation with daily temozolomide that lasts approximately 6 weeks, 3) a study treatment period that will last until either your tumor grows or you experience unacceptable side effects; and 4) a 30-day follow-up period after treatment has ended. Additionally, basic information concerning your condition will be collected every 2 months after the follow-up period for the rest of your life.
During this study, Dr. Nicholas and his research team will collect information about you for the purposes of this research. This includes name, address, dates (i.e., date of birth, date of consent), telephone number, and medical record number. Slides of your tumor tissue that were used to diagnose your GBM will be sent to a pathologist to confirm the diagnosis of GBM. After this review has been completed your slides will be returned to the hospital that provided them. Preserved samples of your tumor will also be sent for a test to determine how effective the temozolomide might be in your case. Any remaining tissue will be returned to the hospital that provided it.
Screening phase (following diagnosis of GBM at surgery) To determine if you are eligible to participate in this study, you will undergo a screening process that will involve the following
- Assessment of your cancer by magnetic resonance imaging (MRI) of your brain using an intravenous (in your vein) contrast material
- Recording of your general medical, surgical and cancer history
- Physical examination, including measurement of your blood pressure, height and weight
- Evaluation of your performance status (your ability to carry on daily activities)
- Neurologic examination (how well your nerves and muscles work)
- Blood sample for laboratory tests (approximately 2 to 3 tablespoons) to evaluate your blood counts, liver, and kidney function
- Serum pregnancy test if you are a woman of childbearing potential
- Urine sample
- Recording of any medications taken within the past 14 days
Radiation and daily temozolomide chemotherapy You will begin radiation treatment within 5 weeks of surgery. You will take temozolomide orally once daily (seven days a week) during radiation treatments (which occur Monday - Friday and last approximately six weeks). You will take a medication to prevent a rare form of pneumonia (pneumocystis carinii) that can occur when temozolomide is given on a daily basis. That may be either in pill form or inhaled. During radiation treatment you will be seen every two weeks by a study doctor at which time you will be asked how you are tolerating the treatment. A physical examination, (including neurological evaluation), will be performed. Blood tests (1-2 tablespoons) will be performed to assure that you are not having any side-effects from the chemotherapy.
Post-radiation treatment Two to four weeks after completing radiation you will have a brain MRI scan. Beginning four weeks after radiation ends, the study drug and temozolomide will begin. The study drug (Avastin) will be administered by IV infusion (through a vein) every 2 weeks. Temozolomide will be taken orally for five consecutive days of every 28 days. In other words, you will receive two intravenous infusions of Avastin and five days of temozolomide every 28 days. This constitutes a treatment cycle. These cycles will continue indefinitely. The dose of Avastin will be based upon your weight during screening and will remain the same throughout the study. The temozolomide dose during radiation will be based on your height and weight at screening. During the study phase, temozolomide will be dosed according to your height and weight at the beginning of each treatment cycle. The dose may be delayed for up to four weeks if your blood counts are low. If temozolomide still cannot be given because your blood counts are low for longer than four weeks, the temozolomide will be stopped but the Avastin may still be continued.
Your first dose of Avastin will be given as over 90 minutes. If you tolerate the 90 minute infusion well, infusions in the future may be given over a shorter period of time. However, if you do not tolerate the shorter infusion time, future infusions will be given over the longer period that you previously tolerated. If you experience any problems during or following the infusion, you will be monitored by trained staff until it is considered safe for you to leave.
The dose of Avastin that you receive may be stopped or slowed based on how well you tolerate the treatment. If you must stop treatment because of unfavorable side effects, you may be able to restart treatment once the side effect has improved or resolved. Your doctor will discuss with you whether it is in your best interest to continue treatment. If you stop study drug treatment, you should continue to return to be evaluated as explained below.
Temozolomide will be taken at bedtime on an empty stomach (at least 2 hours after any meal). Prior to each dose of temozolomide, you will take an anti-nausea pill (ondansetron, granisetron, or dolasetron) to reduce nausea and vomiting.
The treatment cycles described above will continue until: 1) your tumor grows, 2) you have unacceptable side effects, 3) you choose to withdraw from this research study, or 4) your participation is ended by Dr. Nicholas or Genentech.
During the first treatment day of each 28 day cycle you will receive Avastin. Your blood pressure will be monitored, and you will have a physical examination, a neurologic examination, and an evaluation of your performance status (how well you are functioning in daily activities). On the same day, you will begin temozolomide chemotherapy. You will have a blood sample drawn for laboratory tests (approximately 2-3 tablespoons), and a urine sample taken. You will be asked by the study doctor about any health problems you have and medications you take. Additional blood samples may be drawn at the discretion of your doctor as part of your standard care.
On day 14 of every treatment cycle you will return to the clinic to receive an infusion of Avastin. At that time, your blood pressure will be taken, and you will have a physical examination and an evaluation of your performance status. On day 21 of each cycle you will have blood work (1-2 tablespoons) to see how well you are tolerating the treatment. Every 8 weeks (after every 2 cycles immediately prior to your next cycle) you will have an MRI of your brain to determine measurements of your tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one | Experimental | Drug: Bevacizumab and TemozolomideThis is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Disease-Specific Concerns Histologically confirmed GBM as determined by central pathology review Supratentorial location
- General Medical Concerns 18 years of age; Karnofsky performance status > 60; Tumor-related contrast enhancement on initial and post-operative Gd-MRI; Recovery from effects of surgery and/or its complications prior to initiating radiotherapy; Radiotherapy must begin < 5 weeks following surgery; Pre-and post-operative Gd-MRI prior to the initiation of radiotherapy; Adequate hematological, renal, and hepatic function:hemoglobin > 10 grams hematocrit > 30%, platelets > 100,000 per mm3, BUN < 25 mg/dl, Creatinine < 1.5 mg/dl, Total bilirubin < 1.5 mg/dl, SGOT or SGPT < twice institutional normal range, Subjects must not be pregnant or nursing, Use of effective means of contraception (men and women) in subjects of child-bearing (women) and at all ages (men), Study-specific signed informed consent, Ability to comply with study follow-up procedures.
- -
Key exclusion criteria (5 listed)
- a. Disease-Specific Concerns: malignant gliomas graded less than GBM; infratentorial tumor location; recurrent disease; intra-tumoral hemorrhage; Placement of Gliadel® wafers; b. Bevacizumab-Specific Concerns: Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications); Any prior history of hypertensive crisis or hypertensive encephalopathy; History of myocardial infarction or unstable angina within 6 months prior to study enrollment; History of stroke or transient ischemic attack within 6 months prior to study enrollment; New York Heart Association (NYHA) Grade II or greater CHF (see Appendix E); Significant vascular disease (e.g., aortic aneurysm, aortic dissection); Symptomatic peripheral vascular disease; Evidence of bleeding diathesis or coagulopathy; History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment; History of intracerebral abscess within 6 months prior to study enrollment; Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment (exclusive of craniotomy); 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 prior to study enrollment; Serious non-healing wound, ulcer, or bone fracture; Proteinuria at screening as demonstrated by either; Urine protein:creatinine (UPC) ratio 1.0 at screening OR Urine dipstick for proteinuria ≥ 2+ (patients discovered to have ≥2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible); Known hypersensitivity to any component of Avastin. c. General Medical Exclusions
- 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 Avastin cancer study; History of any other malignancy within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix);Pregnant or nursing females; Unstable systemic disease, including active infection, uncontrolled hypertension, or serious cardiac arrhythmias requiring medication;
- Absolute neutrophil count < 1500/ul, Platelet count < 100,000/ul, Total bilirubin > 1.6 mg.dl, AST/ALT > 1.5 x the upper limit of normal ( ULN), Creatinine > 1.2 x ULN, Urine protein/creatinine ratio > 1.0, International normalized ration (INR) > 1.5 and activated partial thromboplastin time (aPTT) > 1.5 x ULN (except for subjects receiving anticoagulation therapy) in the absence of therapeutic intent to anticoagulate the subject. Therapeutic anticoagulation is permitted.
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 |
|---|---|---|
| Bevacizumab and TemozolomideAlso: AvastinThis is an open-label, single arm, multi-center, phase II study involving 48 subjects with newly diagnosed supra-tentorial GBM. Following surgery, subjects with radiographically evaluable disease will receive external beam radiotherapy (59.4 - 60 Gy in 30 - 33 fractions) with daily temozolomide (75 mg/m2). Two to three weeks later, subjects will begin treatment with temozolomide (150-200 mg/m2 daily for five of 28 consecutive days) in conjunction with Avastin (10 mg/kg, every 14 days). | Drug | one |
Primary outcome
Objective Response
Time frame: Up to 3 years
The best clinical response rates determined and 95% confidence intervals obtained using the exact binomial distribution.
Progression-free Survival (PFS)
Time frame: Up to 3 years
4 secondary outcomes
Safety of Avastin in Combination With Temozolomide in This Study Population
Time frame: Up to 3 years
Duration of Response
Time frame: Up to 2 years
Overall Survival
Time frame: Up to 3 years
Changes in Relative Cerebral Blood Volume (rCBV) of Tumors After (2 Infusions) of Avastin
Time frame: Up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Martin Kelly Nicholas, MD PhD principal investigator
University of Chicago
Martin Kelly Nicholas, MD, PhD principal investigator
University of Chicago
5 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 Temozolomide in people with Glioblastoma Multiforme, run by University of Chicago at 5 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 3 inclusion and 5 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 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 1 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 2021.