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

Metastatic Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00983424
• Other study ID #: NU 08B7
• Secondary ID: STU00015585NCI-2
• Status: Completed
• Phase: Phase 1
• First received: September 22, 2009
• Last updated: September 13, 2013
• Start date: February 2010
• Est. completion date: May 2013

Study information

• Verified date: September 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Cyclosporins
dose escalation, administered orally twice a day
• nab-paclitaxel
100 mg/m2 IV days 1, 8 and 15

Locations

Country	Name	City	State
United States	Northwestern University, Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Avon Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	To determine the maximum-tolerated dose (MTD) of Cyclosporine A and nab-paclitaxel in patients.		at study completion (estimated at 2 years)	Yes
Secondary	To describe any preliminary evidence of efficacy of Cyclosporine A and nab-paclitaxel in combination in patients.		every 6-8 weeks	No