Cyclosporine A in Combination With Nab-Paclitaxel in Patients With Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Cyclosporins; Drug: nab-paclitaxel

• Registration Number: NCT00983424
• Lead Sponsor: Northwestern University

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 better than nab-paclitaxel alone.

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-23
• Study First Posted: 2009-09-24
• Study Start: 2010-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-13
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Cyclosporins	Cyclosporine A + nab-paclitaxel
Treatment arm	nab-paclitaxel	Cyclosporine A + nab-paclitaxel

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.	every 6-8 weeks

Trial Locations

Locations (1)

Northwestern University, Northwestern Medical Faculty Foundation; 🇺🇸 Chicago, Illinois, United States