The purpose of this research study is to evaluate the safety of therapy with nab-paclitaxel and CsA and if the addition of Cyclosporine A (CsA) to nab-paclitaxel helps stop cancer cells as well as or better than nab-paclitaxel alone.
Treatment for metastatic breast cancer commonly involves the use of the chemotherapy drug nab-paclitaxel. Nab-paclitaxel is a special preparation of paclitaxel inside a protein layer of albumin. Other studies have shown Cyclosporine A (CsA) may block the progression of advanced breast cancer. The combination of nab-paclitaxel and CsA is considered investigational which means it has not been approved by the US Food and Drug Administration, FDA. Participants on this study will receive nab-paclitaxel through a vein in the arm weekly 3 weeks out of 4, in the outpatient clinic. On the same day as the first infusion of nab-paclitaxel, participants will begin taking CsA tablets twice a day by mouth. Participants will continue to receive study treatment as long as their tumor responds. If the tumor does not respond or the participant experience severe side effects from study treatment, she will be removed from the study and offered other therapies, if that is appropriate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
dose escalation, administered orally twice a day
100 mg/m2 IV days 1, 8 and 15
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States
To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC).
Time frame: labs drawn weekly
To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients.
Time frame: at study completion (estimated at 2 years)
To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.
Time frame: every 6-8 weeks
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