Trial · NCT01125046
Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas
NCT01125046, Phase 2, Completed, Northwestern University; results first posted 2021-01-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas. Trials, record NCT01125046. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01125046
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab in Treating Patients With Recurrent or Progressive Meningiomas
- NCT number
- NCT01125046
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
Acoustic Schwannoma, Adult Anaplastic Meningioma, Adult Ependymoma, Adult Grade I Meningioma, Adult Grade II Meningioma, Adult Meningeal Hemangiopericytoma, Adult Papillary Meningioma, Neurofibromatosis Type 1, Neurofibromatosis Type 2, Recurrent Adult Brain Tumor
- Interventions
- bevacizumab
- First posted
- 2010-05-18
- Last updated
- 2021-01-22
- Results first posted
- 2021-01-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | 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 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). |
| Secondary | Number of Patients With Each Response | 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 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 |
| Secondary | Safety Profile of Bevacizumab | 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 |
| Secondary | Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response | 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 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. |
| 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 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | From the start of treatment and up until 6 months of treatment or follow up | 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. | percentage of patients | NUMBER |
| SECONDARY | Number of Patients With Each Response | From start of treatment and approximately every 8 weeks for up to approximately 5 years ( maximum duration any one patient was on treatment) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety Profile of Bevacizumab | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Levels of VEGF, VEGRfR2 and HER2 Expression in Tumor Tissue as Compared to Response | At baseline and every 8 weeks until disease progression or death. The maximum duration any one patient was on treatment was approximately 5 years. | score on a scale | NUMBER | |
| 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 | At 1 year, 2 years, 3 years post treatment initiation | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group277
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | Treatment With Bevacizumab | Grade I Meningioma | 93 | 95% Confidence Interval 61 to 99 | percentage of patients |
| Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | Treatment With Bevacizumab | Grade II Meningioma | 85 | 95% Confidence Interval 61 to 95 | percentage of patients |
| Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | Treatment With Bevacizumab | Grade III Meningioma | 51 | 95% Confidence Interval 22 to 75 | percentage of patients |
| Progression Free Survival (PFS) of Patients With Recurrent or Progressive Meningiomas Treated With Bevacizumab at 6 Months | Treatment With Bevacizumab | Grade II/III Meningioma | 73 | 95% Confidence Interval 54 to 85 | percentage of patients |
| Number of Patients With Each Response | Treatment With Bevacizumab | Complete Response | 0 | Participants | |
| Number of Patients With Each Response | Treatment With Bevacizumab | Partial Response | 2 | Participants | |
| Number of Patients With Each Response | Treatment With Bevacizumab | Stable Disease | 43 | Participants | |
| Number of Patients With Each Response | Treatment With Bevacizumab | Progressive Diseaase | 4 | Participants | |
| Number of Patients With Each Response | Treatment With Bevacizumab | Death | 1 | Participants | |
| Safety Profile of Bevacizumab | Treatment With Bevacizumab | Hypertension | 10 | Participants |
1 to 10 of 277Source ClinicalTrials.gov
See all 277 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First 6 Months of Treatment | STARTED | Treatment With Bevacizumab | 50 | |
| First 6 Months of Treatment | COMPLETED | Treatment With Bevacizumab | 36 | |
| First 6 Months of Treatment | NOT COMPLETED | Treatment With Bevacizumab | 14 | |
| Continued Treatment After 6 Months | STARTED | Treatment With Bevacizumab | 36 | |
| Continued Treatment After 6 Months | COMPLETED | Treatment With Bevacizumab | 33 | |
| Continued Treatment After 6 Months | NOT COMPLETED | Treatment With Bevacizumab | 3 | |
| Follow-up/Data Cut Off Point | STARTED | Treatment With Bevacizumab | 49 | |
| Follow-up/Data Cut Off Point | COMPLETED | Treatment With Bevacizumab | 16 | |
| Follow-up/Data Cut Off Point | NOT COMPLETED | Treatment With Bevacizumab | 33 |
Source ClinicalTrials.gov
Adverse events119
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment With Bevacizumab | 3 | 50 | |
| other | Auditory/ear NOS | Cardiac disorders | Treatment With Bevacizumab | 2 | 50 | |
| other | Tinnitus | Ear and labyrinth disorders | Treatment With Bevacizumab | 2 | 50 | |
| other | heaing impaired | Ear and labyrinth disorders | Treatment With Bevacizumab | 2 | 50 | |
| other | Blurred vision | Eye disorders | Treatment With Bevacizumab | 2 | 50 | |
| other | Ophthalmoplegia/diplopia (double vision) | Eye disorders | Treatment With Bevacizumab | 3 | 50 | |
| other | ocular vivsual other | Eye disorders | Treatment With Bevacizumab | 2 | 50 | |
| other | cataract | Eye disorders | Treatment With Bevacizumab | 2 | 50 | |
| other | Constipation | Gastrointestinal disorders | Treatment With Bevacizumab | 8 | 50 | |
| other | Gastrointestinal disorders - Diarrhea | Gastrointestinal disorders | Treatment With Bevacizumab | 10 | 50 |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment With Bevacizumab | 30 | 50 |
| Total, other adverse events | Treatment With Bevacizumab | 50 | 50 |
| Total, serious adverse events | Treatment With Bevacizumab | 22 | 50 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01125046
GET https://conductscience.org/api/trials/v1/NCT01125046/results?page=2