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

September 13, 2013 updated by: Northwestern University

A Phase I, Open-label, Study of the Safety and Tolerability of Cyclosporine A (CsA) in Combination With Nab-paclitaxel in Patients With Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Northwestern Medical Faculty Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment arm
Cyclosporine A + nab-paclitaxel
Drug: Cyclosporins
dose escalation, administered orally twice a day
Other Names:
  • Neoral
  • Gengraf
Drug: nab-paclitaxel
100 mg/m2 IV days 1, 8 and 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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).
Time Frame: labs drawn weekly
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)
at study completion (estimated at 2 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.
Time Frame: every 6-8 weeks
every 6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Avon Foundation

Investigators

  • Principal Investigator: William Gradishar, MD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

September 22, 2009

First Submitted That Met QC Criteria

September 23, 2009

First Posted (ESTIMATE)

September 24, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 13, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NU 08B7
  • STU00015585
  • NCI-2011-00223 (OTHER: NCI CTRP#)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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