Status:
COMPLETED
Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Avon Foundation
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Female or male patients with adenocarcinoma of the breast with metastatic disease.
- Patients may have evaluable or measurable disease.
- Age \> 18 years.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Able to swallow and retain oral medication.
- Exclusion Criteria
- Patients who have had any major surgery, hormonal therapy (other than replacement), chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Prior nab-paclitaxel is allowed.
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy.
- Patients with uncontrolled brain metastases or leptomeningeal disease or active neurologic impairment.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cyclosporine A or nab-paclitaxel.
- Pregnant or lactating (Cyclosporine A is excreted into breast milk) females
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- HIV-positive patients are excluded since Cyclosporine A may result in further immunosuppression
Exclusion
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00983424
Start Date
February 1 2010
End Date
May 1 2013
Last Update
September 16 2013
Active Locations (1)
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1
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611