Trial · NCT01207687
Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)
NCT01207687, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-08-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2). Trials, record NCT01207687. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01207687
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bevacizumab for Symptomatic Vestibular Schwannoma in Neurofibromatosis Type 2 (NF2)
- NCT number
- NCT01207687
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Vestibular Schwannoma, Neurofibromatosis Type 2
- Interventions
- bevacizumab, laboratory biomarker analysis, quality-of-life assessment
- First posted
- 2010-09-23
- Last updated
- 2018-08-27
- Results first posted
- 2017-08-17
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Patients With Hearing Response | Baseline to 12 months | A hearing response was defined as increased word recognition score above the 95% critical threshold that is maintained across two sequential evaluation time points. The word recognition score (WRS) is the percentage of phonetically-balanced, monosyllabic words that a patient can accurately repeat presented at either most comfortable level or most intelligible level.The proportion of patients with hearing response in the target ear was estimated using a binomial distribution along with 95% confidence intervals. |
| Secondary | Incidence of Serious or Life Threatening Toxicities | Up to 6 months post-treatment | The number of patients with serious or life threatening toxicities (CTCAE grade 3 or above) |
| Secondary | Radiographic Response | Baseline to 6 months post-treatment | The proportion of participants with radiographic response as measured by a \>/= 20% reduction in tumor volume from baseline on MRI imaging will be estimated using a binomial distribution. |
| Secondary | Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI | Baseline to 12 months | The median percent change in the volume of the target vestibular schwannoma using volumetric MRI |
| Secondary | Number of Participants With Changes in Function of the Auditory System | Baseline to 6 months post-treatment | The primary distortion product optoacoustic emissions (DPOAE) measurement will be treated non-parametrically (present or absent across time) DPOAE's will be considered present at the frequency of F2 when the distortion product is 6dB above the noise floor. Variables will be analyzed for differences using t-tests if the effects and sample sizes warrant, but this may not be advisable given the small numbers to be accrued. |
| Secondary | Percent Change in Median Vascular Permeability (Ktrans) | Baseline to week 72 | Correlation assessment were planned for imaging parameters and hearing response based on the estimated changes in Ktrans: a MRI measure of vascular permeability. Only 1/14 participants had complete Ktrans data that was amenable to analysis at baseline and week 72. Hence, these statistical analyses were not possible. |
| Secondary | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score | Baseline | The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items. |
| Secondary | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores | Baseline | The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population. |
| Secondary | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score | 6 months | The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 1 - 100, with a higher value indicating a more favorable health state. The total score is the median of the all the individual items. |
| Secondary | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores | 6 months | The SF-36 is a patient reported outcome. SF-36 (v.1) was administered and was scored according to instructions found on the RAND website. The range of scores is 0 - 100, with a higher value indicating a more favorable health state. Scores are commonly reported as a physical component summary (PCS) and mental component summary (MCS). The PCS and MCS score have been transformed to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Patients With Hearing Response | Baseline to 12 months | All people who underwent treatment were analyzed. Two patients stopped treatment early. One due to toxicity at week 25 and one due to need for medical care not permitted while on treatment at week 49. | Proportion with hearing response | NUMBER |
| SECONDARY | Incidence of Serious or Life Threatening Toxicities | Up to 6 months post-treatment | Participants evaluated for serious or life threatening toxicities | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Radiographic Response | Baseline to 6 months post-treatment | participants | NUMBER | |
| SECONDARY | Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI | Baseline to 12 months | percentage of change in tumor volume | MEDIAN | |
| SECONDARY | Number of Participants With Changes in Function of the Auditory System | Baseline to 6 months post-treatment | Distortion product optoacoustic emissions (DPOEs) were only obtained for participants at the NCI site; thus, data from 5 participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percent Change in Median Vascular Permeability (Ktrans) | Baseline to week 72 | percent change in median Ktrans | NUMBER | |
| SECONDARY | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score | Baseline | units on a scale | MEDIAN | |
| SECONDARY | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores | Baseline | T-score | MEDIAN | |
| SECONDARY | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Total Score | 6 months | One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point. | units on a scale | MEDIAN |
| SECONDARY | Quality of Life Assessed Using Health Survey Short Form-36 (SF-36) - Component Scores | 6 months | One participant was off study at this point secondary to an adverse event and did not complete the questionnaire. Hence, data from 13 of the 14 participants were available for analysis at this time point. | T-score | MEDIAN |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Patients With Hearing Response | Treatment (Bevacizumab) - All Participants | 0.36 | 95% Confidence Interval 0.13 to 0.65 | Proportion with hearing response | |
| Proportion of Patients With Hearing Response | Treatment (Bevacizumab) - Pediatric Participants Only | 0.50 | 95% Confidence Interval 0.01 to 0.99 | Proportion with hearing response | |
| Incidence of Serious or Life Threatening Toxicities | Treatment (Bevacizumab) - All Participants | 2 | Participants | ||
| Incidence of Serious or Life Threatening Toxicities | Treatment (Bevacizumab) - Pediatric Participants | 0 | Participants | ||
| Radiographic Response | Treatment (Bevacizumab) - All Participants | 0.43 | 95% Confidence Interval 0.18 to 0.71 | participants | |
| Radiographic Response | Treatment (Bevacizumab) - Pediatric Participants | 0.50 | 95% Confidence Interval 0.13 to 0.99 | participants | |
| Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI | Treatment (Bevacizumab) - All Participants | 0.5 | Full Range -29 to 41 | percentage of change in tumor volume | |
| Median Percent Change in Target Vestibular Schwannoma Volume Using Volumetric MRI | Treatment (Bevacizumab) - Pediatric Participants | 10.8 | Full Range 3.4 to 18.2 | percentage of change in tumor volume | |
| Number of Participants With Changes in Function of the Auditory System | Treatment (Bevacizumab) - All Participants | Present | 3 | Participants | |
| Number of Participants With Changes in Function of the Auditory System | Treatment (Bevacizumab) - All Participants | Absent | 2 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Bevacizumab) - All Participants | 14 | |
| Overall Study | COMPLETED | Treatment (Bevacizumab) - All Participants | 12 | |
| Overall Study | NOT COMPLETED | Treatment (Bevacizumab) - All Participants | 2 |
Source ClinicalTrials.gov
Adverse events92
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 | Abdominal pain | Gastrointestinal disorders | Treatment (Bevacizumab) - All Participants | 2 | 14 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Bevacizumab) - Pediatric Participants | 0 | 2 | |
| other | ALT increased | Investigations | Treatment (Bevacizumab) - All Participants | 5 | 14 | 8 |
| other | ALT increased | Investigations | Treatment (Bevacizumab) - Pediatric Participants | 0 | 2 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Bevacizumab) - All Participants | 1 | 14 | 1 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Bevacizumab) - Pediatric Participants | 1 | 2 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Bevacizumab) - All Participants | 1 | 14 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Bevacizumab) - Pediatric Participants | 0 | 2 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Bevacizumab) - All Participants | 1 | 14 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Bevacizumab) - Pediatric Participants | 0 | 2 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Bevacizumab) - All Participants | 0 | 14 |
| Total, all-cause mortality | Treatment (Bevacizumab) - Pediatric Participants | 0 | 2 |
| Total, other adverse events | Treatment (Bevacizumab) - All Participants | 13 | 14 |
| Total, other adverse events | Treatment (Bevacizumab) - Pediatric Participants | 1 | 2 |
| Total, serious adverse events | Treatment (Bevacizumab) - All Participants | 2 | 14 |
| Total, serious adverse events | Treatment (Bevacizumab) - Pediatric Participants | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26976425 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA006973 | Regional Oncology Research Center | NELSON, WILLIAM GEORGE | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment (Bevacizumab) - All Participants vs Treatment (Bevacizumab) - Pediatric Participants: Incidence of Serious or Life Threatening Toxicities | Trial comparisons |
| Treatment (Bevacizumab) - All Participants vs Treatment (Bevacizumab) - Pediatric Participants: deaths from any cause | Trial comparisons |
| Treatment (Bevacizumab) - All Participants vs Treatment (Bevacizumab) - Pediatric Participants: serious adverse events | Trial comparisons |
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/NCT01207687
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