Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer
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.
Central Nervous System Metastases
Recurrent Breast Cancer
Stage IV Breast Cancer
Tumors Metastatic to Brain
Drug: liposomal cytarabine
Other: quality-of-life assessment
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Survival free of neurological progression, measured in weeks [ Time Frame: Time from start of therapy, assessed up to 4 years ] [ Designated as safety issue: No ]Described using Kaplan-Meier survival curves, and confidence intervals for median PFS will be computed.
- Number and percent of patients reporting grade 3+ neurological and systemic adverse events that persists following dose reductions or schedule modifications, assessed using Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Time from start of therapy until death, assessed up to 4 years ] [ Designated as safety issue: No ]Described using Kaplan-Meier survival curves. Measured as time from start of therapy until death, censored on the last date the patient was known to be alive.
- Radiographic response, measured by RECIST using imaging [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Best overall response rate and a 90% Wilson score binomial confidence interval will be determined for evaluable subjects.
- Cytologic response as measured by CSF cytology (positive or negative for malignant cells) [ Time Frame: Up to week 37 ] [ Designated as safety issue: No ]
- Functional Assessment of Cancer Therapy (FACT)-Brain (Br)/CNS total score and subscales (physical well-being, social/family well-being, emotional well-being, functional well-being, symptom index) using standard scoring [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]FACT-BR/CNS total score and subscales will be examined longitudinally for the full study cohort, and for groups defined by length of follow-up (pattern-mixture model), using linear mixed effects regression.
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (liposomal cytarabine, high-dose methotrexate)
See Detailed Description
Other Names:Drug: liposomal cytarabine
Given IT or via LP
Other Names:Other: quality-of-life assessment
Other Name: quality of life assessmentOther: laboratory biomarker analysis
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992602
|United States, California|
|University of California Medical Center At Irvine-Irvine Campus||Recruiting|
|Irvine, California, United States, 92697|
|Contact: Daniela A. Bota 877-827-8839 email@example.com|
|Principal Investigator: Daniela A. Bota|
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Maciej M. Mrugala 206-598-9487|
|Principal Investigator: Maciej M. Mrugala|
|Principal Investigator:||Maciej Mrugala||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|