Trial Outcomes & Findings for Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer (NCT NCT00020722)
NCT ID: NCT00020722
Last Updated: 2016-02-17
Results Overview
TERMINATED
PHASE2
7 participants
Length of time from day of transplant until recurrence or relapse.
2016-02-17
Participant Flow
Participant milestones
| Measure |
Therapeutic Autologous Lymphocytes
therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy Followed by Peripheral Stem Cell Transplantation Plus Biological Therapy in Treating Women With Stage IV Breast Cancer
Baseline characteristics by cohort
| Measure |
Therapeutic Autologous Lymphocytes
n=7 Participants
therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.
The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.
Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.
Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Length of time from day of transplant until recurrence or relapse.Population: Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Length of time from day of transplant until death.Population: Trial converted to a proof-of-principle or concept trial; 7 eligible pts received their ATC infusions, 5 were evaluable. This small number of pts is not adequate for progression-free survival or overall survival analysis, collected and analyzed the data for cytotoxicity, IFN-g EliSpots and serum antibodies to monitor for immune responses.
Outcome measures
Outcome data not reported
Adverse Events
Therapeutic Autologous Lymphocytes
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Lawrence G. Lum, M.D., D.Sc
Barbara Ann Karmanos Cancer Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place