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

This study has been completed.
Sponsor:
Collaborator:
Avon Foundation
Information provided by (Responsible Party):
Northwestern University
ClinicalTrials.gov Identifier:
NCT00983424
First received: September 22, 2009
Last updated: September 13, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Cyclosporins
Drug: nab-paclitaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients. [ Time Frame: at study completion (estimated at 2 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients. [ Time Frame: every 6-8 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: February 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00983424

Locations
United States, Illinois
Northwestern University, Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Avon Foundation
Investigators
Principal Investigator: William Gradishar, MD Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00983424     History of Changes
Other Study ID Numbers: NU 08B7, STU00015585, NCI-2011-00223
Study First Received: September 22, 2009
Last Updated: September 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclosporins
Cyclosporine
Paclitaxel
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 19, 2014