Trial Outcomes & Findings for Liposomal Cytarabine and High-Dose Methotrexate in Treating Patients With Central Nervous System Metastases From Breast Cancer (NCT NCT00992602)

Last Updated: 2017-07-07

Results Overview

Neurological progression defined by either clinical impression (measured by Karnofsky Performance Status), radiographical response (using Macdonald criteria), or cytologic response (measured by CSF cytology).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Time from start of therapy, assessed up to 4 years

Results posted on

2017-07-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Liposomal Cytarabine, High-dose Methotrexate) n=3 Participants 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.
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Time from start of therapy, assessed up to 4 years

Outcome measures

Outcome measures
Measure	Treatment (Liposomal Cytarabine, High-dose Methotrexate) n=3 Participants 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.
Survival Free of Neurological Progression, Measured in Weeks	6 weeks Interval -10.7 to 22.7

SECONDARY outcome

Timeframe: Time from start of therapy until death, assessed up to 4 years

Outcome measures

Outcome measures
Measure	Treatment (Liposomal Cytarabine, High-dose Methotrexate) n=3 Participants 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.
Overall Survival	8.2 months Interval 5.5 to 10.9

Adverse Events

Treatment (Liposomal Cytarabine, High-dose Methotrexate)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Liposomal Cytarabine, High-dose Methotrexate) n=3 participants at risk 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.
Hepatobiliary disorders Transaminitis	66.7% 2/3
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3

Additional Information

Maciej M. Mrugala, MD, PhD, MPH

University of Washington

Phone: 206-543-4069

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place