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Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Maciej Mrugala, University of Washington
ClinicalTrials.gov Identifier:
NCT00992602
First received: October 7, 2009
Last updated: June 7, 2017
Last verified: June 2017
Results First Received: April 7, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Central Nervous System Metastases
Leptomeningeal Metastases
Recurrent Breast Cancer
Stage IV Breast Cancer
Tumors Metastatic to Brain
Interventions: Drug: methotrexate
Drug: liposomal cytarabine
Other: quality-of-life assessment
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Liposomal Cytarabine, High-dose Methotrexate)

Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.

Consolidation phase:

2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.

Maintenance phase:

Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)

Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology.


Participant Flow:   Overall Study
    Treatment (Liposomal Cytarabine, High-dose Methotrexate)
STARTED   3 
COMPLETED   0 
NOT COMPLETED   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment (Liposomal Cytarabine, High-dose Methotrexate)

Induction phase: All patients receive 3 doses of High-Dose Methotrexate (HD-MTX) every 2 weeks given intravenously and 3 doses of Intrathecal (IT) Liposomal Cytarabine (Depocyt) every 2 weeks over 6 weeks.

Consolidation phase:

2 additional doses of HD-MTX every 2 weeks and IT-Depocyt every 2 weeks for 4 more weeks.

Maintenance phase:

Monthly doses of HD-MTX (up to 6 doses) and IT-Depocyt (up to 5 doses)

Patients must stop participation anytime MRI shows progressive disease or positive CSF cytology.


Baseline Measures
   Treatment (Liposomal Cytarabine, High-dose Methotrexate) 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      3 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3 100.0% 
Male      0   0.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  33.3% 
Not Hispanic or Latino      2  66.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      3 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Survival Free of Neurological Progression, Measured in Weeks   [ Time Frame: Time from start of therapy, assessed up to 4 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Time from start of therapy until death, assessed up to 4 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Our accrual limitations highlight the challenges of conducting studies in “orphan diseases” such as LC and underscore the importance of multi-center collaboration.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Maciej M. Mrugala, MD, PhD, MPH
Organization: University of Washington
phone: 206-543-4069
e-mail: mmrugala@uw.edu



Responsible Party: Maciej Mrugala, University of Washington
ClinicalTrials.gov Identifier: NCT00992602     History of Changes
Other Study ID Numbers: 6954
NCI-2009-01309 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
6954 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
Study First Received: October 7, 2009
Results First Received: April 7, 2017
Last Updated: June 7, 2017