High-dose Methotrexate and Liposomal Cytarabine in Treating Patients With CNS Metastases From Breast Cancer
This phase II trial is studying how well giving high-dose methotrexate together with liposomal cytarabine works in treating patients with central nervous system (CNS) metastases from metastatic breast cancer. Drugs used in chemotherapy, such as methotrexate and liposomal cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose systemic methotrexate with intra-cerebral spinal fluid (CSF) liposomal cytarabine 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: questionnaire administration
|Study Design:||Endpoint Classification: Safety/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|
- Progression-free survival (PFS) [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Described using Kaplan-Meier survival curves, and confidence intervals for median PFS will be computed. A 95% confidence interval lower bound greater than 7 weeks would be strong evidence for efficacy of the combined treatment regimen. However, an observed median PFS of 12 weeks or greater would also show promise for the combined therapy.
- Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria grade 3+ neurological and systemic toxicity that persists following dose reductions or schedule modifications [ Time Frame: Up to 30 days post-treatment ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 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.
- Duration of response [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]Described using Kaplan-Meier survival curves. Radiographic response will be measured by the RECIST criteria.
- Cytologic response as measured by CSF cytology (positive or negative for malignant cells) [ Time Frame: Up to week 37 ] [ Designated as safety issue: No ]
- FACT-Brain (Br) total score and subscales (physical well-being, social/family well-being, emotional well-being, functional well-being, symptom index) using standard scoring [ Time Frame: Assessed every 4 weeks until withdrawal from study ] [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
INDUCTION THERAPY (weeks 1-6): Patients receive high-dose methotrexate IV over 4 hours on days 1, 15, and 29 and liposomal cytarabine IT or LP over 5 minutes on days 8, 22, and 36.
CONSOLIDATION THERAPY (weeks 7-11): Patients achieving CR, PR, or SD then receive high-dose methotrexate IV over 4 hours on days 43 and 57. Patients also receive liposomal cytarabine IT or LP over 5 minutes on days 50 and 64.
MAINTENANCE THERAPY (weeks 13-37): Patients achieving CR, PR, or SD receive high-dose methotrexate IV over 4 hours once monthly and beginning in week 15, patients receive liposomal cytarabine IT or LP over 5 minutes once monthly. Treatment repeats once monthly for 5-6 courses in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: liposomal cytarabine
Other Names:Other: quality-of-life assessment
Other Name: quality of life assessmentOther: questionnaire administration
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00992602
|United States, Rhode Island|
|Rhode Island Hospital||Recruiting|
|Providence, Rhode Island, United States, 02903|
|Contact: Suriya Jeyapalan 401-444-1488|
|Principal Investigator: Suriya Jeyapalan|
|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|