18 and older, any sex, with Acoustic Schwannoma or Adult Anaplastic Meningioma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 MonthsPrimary· From the start of treatment and up until 6 months of treatment or follow up
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 eval
Grade I Meningioma
Group
Value
95% CI
Treatment With Bevacizumab
93
61 – 99
Grade II Meningioma
Group
Value
95% CI
Treatment With Bevacizumab
85
61 – 95
Grade III Meningioma
Group
Value
95% CI
Treatment With Bevacizumab
51
22 – 75
Grade II/III Meningioma
Group
Value
95% CI
Treatment With Bevacizumab
73
54 – 85
Number of Patients With Each ResponseSecondary· From start of treatment and approximately every 8 weeks for up to approximately 5 years ( maximum duration any one patient was on treatment)
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
Group
Value
95% CI
Treatment With Bevacizumab
0
Treatment With Bevacizumab
2
Treatment With Bevacizumab
43
Treatment With Bevacizumab
4
Safety Profile of BevacizumabSecondary· 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.
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
Hypertension
Group
Value
95% CI
Treatment With Bevacizumab
10
Hyponatremia
Group
Value
95% CI
Treatment With Bevacizumab
2
Proteinuria
Group
Value
95% CI
Treatment With Bevacizumab
2
Ataxia
Group
Value
95% CI
Treatment With Bevacizumab
1
Pancreatitis
Group
Value
95% CI
Treatment With Bevacizumab
1
Nausea/Vomiting
Group
Value
95% CI
Treatment With Bevacizumab
1
Elevated Lipase
Group
Value
95% CI
Treatment With Bevacizumab
1
Anemia
Group
Value
95% CI
Treatment With Bevacizumab
1
Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to ResponseSecondary· At baseline and every 8 weeks until disease progression or death. The maximum duration any one patient was on treatment was approximately 5 years.
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 percenta
#01/Partial Response : VEGF Score
Group
Value
95% CI
Treatment With Bevacizumab
1
#01/Partial Response : VEGF Expression
Group
Value
95% CI
Treatment With Bevacizumab
30
#01/Partial Response : VEGRfR2 Score
Group
Value
95% CI
Treatment With Bevacizumab
1
#01/Partial Response : VEGRfR2 Expression
Group
Value
95% CI
Treatment With Bevacizumab
10
#01/Partial Response : HER2 Score
Group
Value
95% CI
Treatment With Bevacizumab
0
#01/Partial Response : HER2 Expression
Group
Value
95% CI
Treatment With Bevacizumab
0
#02/Stable Disease : VEGF Score
Group
Value
95% CI
Treatment With Bevacizumab
2
#02/Stable Disease : VEGF Expression
Group
Value
95% CI
Treatment With Bevacizumab
80
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 BevacizumabSecondary· At 1 year, 2 years, 3 years post treatment initiation
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
Group
Value
95% CI
Treatment With Bevacizumab
43
At 2 years
Group
Value
95% CI
Treatment With Bevacizumab
31
At 3 years
Group
Value
95% CI
Treatment With Bevacizumab
16
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 4%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Treatment With Bevacizumab
Serious: 22/50 (44%)
Deaths: 30/50
Serious adverse events (30 terms)
Reaction
System
Treatment With Bevacizumab
Seizure
Nervous system disorders
—
Pancreatitis
Gastrointestinal disorders
—
Anorectal Infection
Infections and infestations
—
Muscle weakness
Musculoskeletal and connective tissue disorders
—
Toxic Metabolic Encephalopathy
Nervous system disorders
—
Epistaxis
General disorders
—
Aphasia
Nervous system disorders
—
Anemia
Blood and lymphatic system disorders
—
Fracture
Injury, poisoning and procedural complications
—
Left sided apraxia and numbness
Nervous system disorders
—
Muscle weakness and spasticity
Musculoskeletal and connective tissue disorders
—
Left-sided paralysis
Nervous system disorders
—
RPLS
Nervous system disorders
—
Pain: Musculoskeletal
Musculoskeletal and connective tissue disorders
—
Somnolence d/t narcotic overdose
Nervous system disorders
—
Weakness- Lower Extremity
Musculoskeletal and connective tissue disorders
—
CNS Cebrovascular Ischemia
Nervous system disorders
—
Infection (ventriculitis)
Infections and infestations
—
Eye Infection
Infections and infestations
—
Headache
Nervous system disorders
—
Viral Bronchitis
Infections and infestations
—
Pneymocephalus
Nervous system disorders
—
Wound Infection
Infections and infestations
—
Fall
Injury, poisoning and procedural complications
—
Hip Prosthesis Dislocation
Injury, poisoning and procedural complications
—
Other adverse events (89 terms — click to expand)
Reaction
System
Treatment With Bevacizumab
General disorders and administration site conditions - Fatigue
General disorders
—
Headaches
Nervous system disorders
—
Hypertension
Vascular disorders
—
Hyperglycemia
Metabolism and nutrition disorders
—
General disorders and administration site conditions - pain
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· Phase 2
· recruiting
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· recruiting
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· Phase 1, PHASE2
· recruiting
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· terminated
NCT06487715 — Safety and Efficacy of Systemic Chemotherapy Plus PD-1 Inhibitor in Combination With Bevacizumab in Gastric Cancer With
· Phase 2
· unknown
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 22 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01125046.