Trial · NCT00924820
A Pilot Study of Bevacizumab for Neoplastic Meningitis
NCT00924820, Phase 1, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2020-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of Bevacizumab for Neoplastic Meningitis. Trials, record NCT00924820. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00924820
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Bevacizumab for Neoplastic Meningitis
- NCT number
- NCT00924820
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Neoplastic Meningitis
- Interventions
- Bevacizumab
- First posted
- 2009-06-19
- Last updated
- 2020-12-31
- Results first posted
- 2020-12-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells | 1 year (54 weeks) of treatment | CSF response for participants with Neoplastic Meningitis (NM) or leptomeningeal disease (LMD) defined as conversion from positive to negative cytology or cytometry as measured routinely by total clearance of malignant cells from the CSF where assessments performed from 2 weeks up to week 54 of treatment. Clearance of malignant cells determined by standard clinical testing using cytospin analysis in clinical laboratory. Percentage reflects number of participants of total treated with no response, e.g. participants with continued positive CSF cytology or flow cytometry. |
| Primary | Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP) | 6 weeks | Time to Progression defined as time to disease progression measured from date of enrollment, confirmation of disease progression via laboratory testing; Time to neurological progression (TTNP) reflects worsening clinical signs/symptoms or development of new clinical signs/symptoms which investigator feels can be attributed to leptomeningeal disease progression and are severe enough to warrant a change in therapy. |
| Other | Participant Response: Cerebrospinal Fluid (CSF) Examination | 1 year (54 weeks) of treatment | Neoplastic meningitis is considered an unmeasurable metastatic site by Response Evaluation Criteria in Solid Tumors (RECIST), and as such no standardized methodologies are routinely used; therefore response assessed from cerebrospinal fluid (CSF) obtained via lumbar puncture (and from ventricular reservoir if present) and analyzed for malignant cells along with reference recording of magnetic resonance imaging (MRI) of areas of enhancement over time; however, MRI alone in LMD/NM is considered non-evaluable by RECIST criteria. Those participants with only MRI criteria for enrollment, but who later develop CSF positivity after enrollment were declared "progressors" based on the CSF criteria. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells | 1 year (54 weeks) of treatment | Of the 20 registered, 5 were screening failures therefore are not included in the analysis. | percentage of participants | NUMBER |
| PRIMARY | Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP) | 6 weeks | Of the 20 registered, 5 were screening failures therefore are not included in the analysis. | Weeks | MEDIAN |
| OTHER_PRE_SPECIFIED | Participant Response: Cerebrospinal Fluid (CSF) Examination | 1 year (54 weeks) of treatment | Of the 20 registered, 5 were screening failures therefore are not included in the analysis. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cerebrospinal Fluid (CSF) Response Rate: Percentage of Participants Positive for Tumor Cells | Bevacizumab | 93 | percentage of participants | ||
| Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP) | Bevacizumab | TTP | 3 | Full Range 0 to 6 | Weeks |
| Median Time to Progression (TTP) and Median Time to Neurological Progression (TTNP) | Bevacizumab | TTNP | 3 | Full Range 0 to 6 | Weeks |
| Participant Response: Cerebrospinal Fluid (CSF) Examination | Bevacizumab | No Change/Stable Disease (SD) | 6 | participants | |
| Participant Response: Cerebrospinal Fluid (CSF) Examination | Bevacizumab | Progressive Disease (PD) | 8 | participants | |
| Participant Response: Cerebrospinal Fluid (CSF) Examination | Bevacizumab | Complete Remission (CR) | 1 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bevacizumab | 20 | |
| Overall Study | COMPLETED | Bevacizumab | 13 | |
| Overall Study | NOT COMPLETED | Bevacizumab | 7 |
Source ClinicalTrials.gov
Adverse events135
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 distension | Gastrointestinal disorders | Bevacizumab | 1 | 15 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Bevacizumab | 8 | 15 | 9 |
| other | Adult Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Bevacizumab | 1 | 15 | 1 |
| other | Agitation | Psychiatric disorders | Bevacizumab | 1 | 15 | 1 |
| other | Alanine aminotransferase increased | Investigations | Bevacizumab | 5 | 15 | 5 |
| other | Alkaline phosphatase increased | Investigations | Bevacizumab | 4 | 15 | 6 |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Bevacizumab | 3 | 15 | 3 |
| other | Alopecia | Skin and subcutaneous tissue disorders | Bevacizumab | 7 | 15 | 7 |
| other | Anorexia | Metabolism and nutrition disorders | Bevacizumab | 9 | 15 | 11 |
| other | Anxiety | Psychiatric disorders | Bevacizumab | 6 | 15 | 6 |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bevacizumab | ||
| Total, other adverse events | Bevacizumab | 15 | 15 |
| Total, serious adverse events | Bevacizumab | 11 | 15 |
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/NCT00924820
GET https://conductscience.org/api/trials/v1/NCT00924820/events?page=2