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RATIONALE: 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-CSF liposomal cytarabine may kill more tumor cells.
I. To show that treatment with HD-MTX in combination with IT liposomal cytarabine will result in median progression-free survival (PFS) greater than 7 weeks for patients with parenchymal and leptomeningeal metastases from breast cancer.
I. To describe the overall survival of patients with CNS metastatic breast cancer treated with the combination of IV HD-MTX and liposomal cytarabine.
II. To describe the safety of the combination therapy, in terms of toxicity, adverse events, and the need for dose reductions or schedule modification.
III. To estimate the best overall response rate achieved during treatment with IV HD-MTX and liposomal cytarabine. Radiographic response will be measured by the Macdonald Criteria using imaging (MRI), and cytologic response will be measured by CSF cytology.
IV. To determine the number of treatment cycles needed to achieve radiographic and cytologic response. Time to progression and duration of the response will also be measured.
V. To describe response duration in patients who achieve at least partial radiographic response and cytologic clearance.
VI. To define time to clinical progression as measured by KPS and neurological exam.
VII. To describe functional status and quality of life of patients, through clinical evaluations of neurological status and patient-reported quality of life (QOL) measured by the Functional Assessment of Chronic Illness Therapy (FACIT) brain and/or CNS questionnaires.
VIII. To correlate response rates with the extent of patient's systemic disease and tumor receptor status (ER, PR, Her2).
INDUCTION THERAPY (weeks 1-6): Patients receive high-dose methotrexate IV over 4 hours on days 1, 15, and 29 and liposomal cytarabine intrathecally (IT) over 5 minutes on days 8, 22, and 36.
CONSOLIDATION THERAPY (weeks 7-11): Patients achieving complete response (CR), partial response (PR), or stable disease (SD) then receive high-dose methotrexate IV over 4 hours on days 43 and 57. Patients also receive liposomal cytarabine IT 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 over 5 minutes once monthly. Treatment repeats once monthly for 5-6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Stage IV Breast Cancer
methotrexate, liposomal cytarabine, quality-of-life assessment, questionnaire administration
Dana-Farber Harvard Cancer Center
Fred Hutchinson Cancer Research Center
Published on BioPortfolio: 2014-08-27T03:18:46-0400
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A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)
Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.
A generic concept reflecting concern with the modification and enhancement of life attributes, e.g., physical, political, moral and social environment; the overall condition of a human life.
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