CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 3 enrolled
Drug / intervention
methotrexate +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00992602
NCT00992602Phase 2Completed
CompareCT.gov

Phase II Study of the Combination of High-Dose Methotrexate and Intrathecal Liposomal Cytarabine in Patients With Leptomeningeal Metastases With or Without Parenchymal Brain Involvement

University of Washington·interventional·Posted Oct 9, 2009·Updated Jul 7, 2017

In Brief

A Phase 2 clinical trial evaluating methotrexate, liposomal cytarabine, and 2 other interventions for Central Nervous System Metastases and 4 related conditions. Completed, enrolled 3 participants across 1 site.

Detailed Summary

This phase II trial studies how well giving liposomal cytarabine and high-dose methotrexate works in treating patients with breast cancer that has spread to the central nervous system. Drugs used in chemotherapy, such as liposomal cytarabine and methotrexate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving liposomal cytarabine with high-dose methotrexate may kill more tumor cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCentral Nervous System Metastases, Leptomeningeal Metastases, Recurrent Breast Cancer, Stage IV Breast Cancer, Tumors Metastatic to Brain
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 9, 2009
Enrollment StartApr 1, 2011
Primary CompletionJun 1, 2013
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.7 years ago

Interventions

methotrexatedrug

Given IV

liposomal cytarabinedrug

Given IT or via LP

quality-of-life assessmentother

Ancillary studies

laboratory biomarker analysisother

Correlative studies