Trial · NCT00992602
Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer
NCT00992602, Phase 2, Completed, University of Washington; results first posted 2017-07-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer. Trials, record NCT00992602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00992602
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer
- NCT number
- NCT00992602
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Central Nervous System Metastases, Leptomeningeal Metastases, Recurrent Breast Cancer, Stage IV Breast Cancer, Tumors Metastatic to Brain
- Interventions
- methotrexate, liposomal cytarabine, quality-of-life assessment, laboratory biomarker analysis
- First posted
- 2009-10-09
- Last updated
- 2017-07-07
- Results first posted
- 2017-07-07
- Limitations and caveats
- Our accrual limitations highlight the challenges of conducting studies in orphan diseases such as LC and underscore the importance of multi-center collaboration.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival Free of Neurological Progression, Measured in Weeks | Time from start of therapy, assessed up to 4 years | Neurological progression defined by either clinical impression (measured by Karnofsky Performance Status), radiographical response (using Macdonald criteria), or cytologic response (measured by CSF cytology). |
| Secondary | Overall Survival | Time from start of therapy until death, assessed up to 4 years |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival Free of Neurological Progression, Measured in Weeks | Time from start of therapy, assessed up to 4 years | weeks | MEDIAN | |
| SECONDARY | Overall Survival | Time from start of therapy until death, assessed up to 4 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival Free of Neurological Progression, Measured in Weeks | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 6 | 95% Confidence Interval -10.7 to 22.7 | weeks | |
| Overall Survival | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 8.2 | 95% Confidence Interval 5.5 to 10.9 | months |
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 | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 3 | |
| Overall Study | COMPLETED | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 0 | |
| Overall Study | NOT COMPLETED | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 3 |
Source ClinicalTrials.gov
Adverse events2
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 | Transaminitis | Hepatobiliary disorders | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 2 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 1 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 3 | 3 |
| Total, other adverse events | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 2 | 3 |
| Total, serious adverse events | Treatment (Liposomal Cytarabine, High-dose Methotrexate) | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00992602
GET https://conductscience.org/api/trials/v1/NCT00992602/registered