Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00843 | |||
| STU00024715 | Other Identifier | Northwestern University IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
PURPOSE: This phase II trial is studying how well bevacizumab works in treating patients with recurrent or progression meningiomas.
PRIMARY OBJECTIVES:
I. To determine the efficacy of bevacizumab in patients with recurrent or progressive benign and atypical/malignant meningiomas, despite prior therapy, as measured by six-month progression-free survival.
SECONDARY OBJECTIVES:
I. To describe the response rate and overall-survival in this patient population.
II. To evaluate the safety profile of bevacizumab in patients with recurrent meningiomas.
III. To perform an exploratory study in patients with hemangioblastoma and hemangiopericytoma.
IV. To assess tissue for VEGF and VEGFR to correlate with response. An exploratory analysis of HER-2 will be performed.
OUTLINE:
Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months. Patients may then receive bevacizumab IV every 3 weeks for up to 12 months. Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months. Patients may then receive bevacizumab IV every 3 weeks for up to 12 months. Treatment continues in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | Given IV |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | Progression Free Survival (PFS) of patients with recurrent or progressive benign and atypical/malignant Meningiomas (grades I-III), despite prior therapy treated with bevacizumab will be defined from the time of registration to the study until the time of first documentation of progressive disease or death from any cause. Progressive disease will be assessed based on the Macdonald Criteria and is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). | From the start of treatment and up until 6 months of treatment or follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Each Response | Best Response of patients treated with bevacizumab with diagnosis of any of the following: meningioma, hemangiopericytoma, hemangioblastoma, acustic neuroma or schwanoma will be assessed using the MacDonald Criteria. In general: Complete Response-Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients not on steroids. Partial Response-50% or greater decrease under baseline in the sum of products of perpendicular diameters of the two largest measurable lesions. No progression of evaluable disease. No new lesions. Stable Disease-Not CR or PR or PD. Progressive disease (PD)-25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear worsening or failure to return for evaluation due to death/deteriorating condition |
Not provided
Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Priya Kumthekar, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Dana-Farber Cancer Institute |
Not provided
The study opened for accrual on May 19, 2010 with an accrual goal of up to 50 patients. First patient started treatment on 6/17/2010. The study was closed permanently to further enrollment on September 24, 2013 when accrual was met.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment With Bevacizumab | Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician. bevacizumab: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First 6 Months of Treatment |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From start of treatment and approximately every 8 weeks for up to approximately 5 years ( maximum duration any one patient was on treatment) |
| Safety Profile of Bevacizumab | Safety of bevacizumab in patients with diagnosis of any of the following: meningioma, hemangiopericytoma, hemangioblastoma, acustic neuroma or schwanoma, will be assessed by collecting the number of adverse events experienced by patients that were determined to be at least possibly related to bevacaumab and assessed as a grade 3 or 4. AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. In general, AEs will be graded as follows: Grade 1 - Mild Grade 2 - Moderate Grade 3 - Severe Grade 4 - Life-threatening Grade 5 - Fatal | Every 2 weeks or 3 weeks while on treatment up to 30 days after the last dose. The maximum duration any one patient was on treatment was approximately 5 years. |
| Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response | Tissue was collected for VEGF, VEGRfR2 and HER2 at baseline. Patients underwent radiological assessments every 8 weeks during treatment to determine disease status to treatment (complete response/partial response/stable disease/progressive disease). The level of VEGF, VEGRfR2 and HER2 marker expression was compared with the response as determined at the time of disease progression or death. Immunohistochemistry (IHC) will be analyzed using blobfinder technology. Each sample was given a score for the markers expression in the tissue 1, 2 or 3 (1=+, 2=++, 3=+++, from low to high) and a percentage 0-100% (low to high) of how much tissue it was expressed in. If score = 0 and percentage =0 the sample was negative for that marker. If score = 1 and percentage =10% the marker had an expression of 1 (+) in 10 percent of the tissue and so forth. The data is shown by patient and their best response to treatment with their score and expression for VEGF, VEGRfR2 and HER2. | At baseline and every 8 weeks until disease progression or death. The maximum duration any one patient was on treatment was approximately 5 years. |
| Number of Patients Alive at 1 Year, 2 Years and 3 Years Post Treatment Initiation (Overall Survival) for Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab | Overall Survival (OS) of patients with Recurrent or Progressive Meningiomas Treated with Bevacizumab will be measured from the time of treatment initiation to the study until death from any cause. The raw data of number of patients documented as being alive at 1 year, 2 year, and 3 years post treatment initiation is reported here. | At 1 year, 2 years, 3 years post treatment initiation |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| University of Washington | Seattle | Washington | 98109-1023 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Continued Treatment After 6 Months |
|
|
| Follow-up/Data Cut Off Point |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment With Bevacizumab | Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician. bevacizumab: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||||
| Stage of Disease (at study entry) | Grading of disease was based on the degree of anaplasia, number of mitosis, and presence of necrosis using World Health Organization (WHO) classification of tumors of the central nervous system. Grades in general are as follows: Grade I - Benign Grade II - Atypical Grade III - Malignant | Count of Participants | Participants |
| |||||||||||||||||||
| Diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | Progression Free Survival (PFS) of patients with recurrent or progressive benign and atypical/malignant Meningiomas (grades I-III), despite prior therapy treated with bevacizumab will be defined from the time of registration to the study until the time of first documentation of progressive disease or death from any cause. Progressive disease will be assessed based on the Macdonald Criteria and is defined as 25% increase in the sum of products of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear worsening or failure to return for evaluation due to death or deteriorating condition (unless clearly unrelated to this cancer). | PFS was analyzed based on grading of meningioma due to the difference in prognosis of grades to provide meaningful results. In general, grade I tumor grows slowly, grade II tumor grows more quickly and is often called atypical meningioma, and grade III tumor grows and spreads very quickly and is often called anaplastic or malignant meningioma. | Posted | Number | 95% Confidence Interval | percentage of patients | From the start of treatment and up until 6 months of treatment or follow up |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Patients With Each Response | Best Response of patients treated with bevacizumab with diagnosis of any of the following: meningioma, hemangiopericytoma, hemangioblastoma, acustic neuroma or schwanoma will be assessed using the MacDonald Criteria. In general: Complete Response-Complete disappearance of all measurable and evaluable disease. No new lesions. No evidence of non-evaluable disease. Patients not on steroids. Partial Response-50% or greater decrease under baseline in the sum of products of perpendicular diameters of the two largest measurable lesions. No progression of evaluable disease. No new lesions. Stable Disease-Not CR or PR or PD. Progressive disease (PD)-25% increase in the sum of products of all measurable lesions over smallest sum observed, OR clear worsening of any evaluable disease, OR appearance of any new lesion/site, OR clear worsening or failure to return for evaluation due to death/deteriorating condition | Posted | Count of Participants | Participants | From start of treatment and approximately every 8 weeks for up to approximately 5 years ( maximum duration any one patient was on treatment) |
| |||||||||||||||||||||||||||||||
| Secondary | Safety Profile of Bevacizumab | Safety of bevacizumab in patients with diagnosis of any of the following: meningioma, hemangiopericytoma, hemangioblastoma, acustic neuroma or schwanoma, will be assessed by collecting the number of adverse events experienced by patients that were determined to be at least possibly related to bevacaumab and assessed as a grade 3 or 4. AEs will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0. In general, AEs will be graded as follows: Grade 1 - Mild Grade 2 - Moderate Grade 3 - Severe Grade 4 - Life-threatening Grade 5 - Fatal | Posted | Count of Participants | Participants | No | Every 2 weeks or 3 weeks while on treatment up to 30 days after the last dose. The maximum duration any one patient was on treatment was approximately 5 years. |
|
| |||||||||||||||||||||||||||||
| Secondary | Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response | Tissue was collected for VEGF, VEGRfR2 and HER2 at baseline. Patients underwent radiological assessments every 8 weeks during treatment to determine disease status to treatment (complete response/partial response/stable disease/progressive disease). The level of VEGF, VEGRfR2 and HER2 marker expression was compared with the response as determined at the time of disease progression or death. Immunohistochemistry (IHC) will be analyzed using blobfinder technology. Each sample was given a score for the markers expression in the tissue 1, 2 or 3 (1=+, 2=++, 3=+++, from low to high) and a percentage 0-100% (low to high) of how much tissue it was expressed in. If score = 0 and percentage =0 the sample was negative for that marker. If score = 1 and percentage =10% the marker had an expression of 1 (+) in 10 percent of the tissue and so forth. The data is shown by patient and their best response to treatment with their score and expression for VEGF, VEGRfR2 and HER2. | Posted | Number | score on a scale | At baseline and every 8 weeks until disease progression or death. The maximum duration any one patient was on treatment was approximately 5 years. |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Patients Alive at 1 Year, 2 Years and 3 Years Post Treatment Initiation (Overall Survival) for Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab | Overall Survival (OS) of patients with Recurrent or Progressive Meningiomas Treated with Bevacizumab will be measured from the time of treatment initiation to the study until death from any cause. The raw data of number of patients documented as being alive at 1 year, 2 year, and 3 years post treatment initiation is reported here. | 2 patients were considered lost to follow up at year 2 and year 3 respectively and were not included in the numbers. Data cut off was Dec 2018 and those who had not reached 3 years are not included in the 3 year number of patients alive. No survival data was collected at these timepoints. | Posted | Count of Participants | Participants | No | At 1 year, 2 years, 3 years post treatment initiation |
|
Adverse events were collected from the time of treatment initiation until 30 days post treatment discontinuation for all patients. Range of cycles of treatment completed by patients was 1-47 where one cycle equals 28 days on bevaciumab every 2 week schedule and 42 days on bevacizumab every 3 weeks. Longest time any patient was on treatment was 5 years.
Data that has been collected in the database is reported here. There is still some data entry of other adverse events for a few patient being completed and this Section will be updated accordingly when all data is entered and available for reporting (if applicable).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment With Bevacizumab | Patients receive bevacizumab IV over 30-90 minutes every 2 weeks for 6 months (1 cycle = 28 days with two doses of bevacizumab). Patients may then receive bevacizumab IV every 3 weeks for up to 12 months (1 cycle = 42 days) or stay on the 2 week cycle at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After 12 months of treatment patients may continue on bevacizumab at the discretion of their treating physician. bevacizumab: Given IV | 30 | 50 | 22 | 50 | 50 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Patient with increased lipase at the time of the event |
|
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorectal Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Patient also with ataxia and speech impairment at the time of the event |
|
| Toxic Metabolic Encephalopathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Left sided apraxia and numbness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness and spasticity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment | Patient also with tremors at the time of the event |
|
| Left-sided paralysis | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| RPLS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain: Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Somnolence d/t narcotic overdose | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weakness- Lower Extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| CNS Cebrovascular Ischemia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infection (ventriculitis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Viral Bronchitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Pneymocephalus | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Wound Infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Patient with Pyramidal tract disturbance and gait disturbance at the time of the event |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Patient had facture due to the fall |
|
| Hip Prosthesis Dislocation | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment | Patient also with hip pain, bruising and confusion due to the event |
|
| Seizures and cognitive disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment | Patient also with altered mental status and muscle weakness thought to be due to the event |
|
| Hemorrhage - CNS | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Disease progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphasia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment | Patient Died during this event. Reason of death unclear |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Auditory/ear NOS | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| heaing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Ophthalmoplegia/diplopia (double vision) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ocular vivsual other | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| cataract | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhage - oral cavity | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gastrointestinal disorders - dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - Gait disturbance | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| General disorders and administration site conditions - pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| ear infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations - other, specify | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Infections and infestations -Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Creatinine increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Bicarbonate Serum Low | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Neutrophil count decrease | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Investigations - White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypomagnesmia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| BUN elevated | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urine - WBCs detected | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urine Casts detected | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chloride Elevated | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Teeth pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| extremity limb pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness - extraocular | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Muscle weakness - extremity lower | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Shoulder Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Spasicity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cognitive Disturbance | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| dysarthria | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headaches | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| somnolence | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seizure | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Agitation | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| renal/genitourinary - other | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| irregular menstration | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nose bleed | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pulmonary/ upper respiratory - otheh | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vascular other | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Priya Kumthekar, MD | Northwestern University | Priya.Kumthekar@nm.org |
| ID | Term |
|---|---|
| D009464 | Neuroma, Acoustic |
| D008579 | Meningioma |
| D004806 | Ependymoma |
| D009456 | Neurofibromatosis 1 |
| D016518 | Neurofibromatosis 2 |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009442 | Neurilemmoma |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009463 | Neuroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D003390 | Cranial Nerve Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D010524 | Peripheral Nervous System Neoplasms |
| D000160 | Vestibulocochlear Nerve Diseases |
| D012181 | Retrocochlear Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Stage III |
|
| Acoustic Neuroma/Vestibular Schwannoma |
|
|
| Grade III Meningioma |
|
|
| Grade II/III Meningioma |
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|