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| ID | Type | Description | Link |
|---|---|---|---|
| STU00015585 | |||
| NCI-2011-00223 | Other Identifier | NCI CTRP# |
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| Name | Class |
|---|---|
| Avon Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Cyclosporine A + nab-paclitaxel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclosporins | Drug | dose escalation, administered orally twice a day |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety, tolerability and feasibility of the combination of Cyclosporine A and nab-paclitaxel in the treatment of metastatic breast cancer (MBC). | labs drawn weekly | |
| To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients. | at study completion (estimated at 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients. | every 6-8 weeks |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| William Gradishar, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D016572 | Cyclosporine |
| C520255 | 130-nm albumin-bound paclitaxel |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| nab-paclitaxel | Drug | 100 mg/m2 IV days 1, 8 and 15 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |