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Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

Primary Purpose

Breast Cancer, Breast Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imiquimod
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring toll-like receptor, toll-like receptor agonist, recurrent breast cancer, breast cancer metastasized to skin and/or chestwall, immunomodulator

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable).
  • Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible).
  • Skin metastases not suitable for or patient refusing definitive surgical resection and radiation.
  • (Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator.

(Cohort 2) Any concurrent systemic therapy is allowed

  • Age at least 18 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.
  • Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies required by protocol.

  • Patients must have adequate organ and bone marrow function as defined below:

    • absolute neutrophil count > or = 1,500/microliter
    • hemoglobin > or = 9.5 grams/deciliter
    • platelets >or = 75,000/microliter
    • total bilirubin < or = 1.5 X institutional upper limit of normal
    • Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X institutional upper limit of normal
    • creatinine < or = 1.5 X institutional upper limit of normal
  • Informed consent.

Exclusion Criteria:

  • Brain metastases unless resected or irradiated and stable > or = 8 weeks.
  • Treatment with other investigational agents.
  • Patients who have received radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks prior to first dosing of study agent.
  • Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent.
  • Patients with an uncontrolled bleeding disorder.
  • Patients who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible.
  • Patients with known immunodeficiency or receiving immunosuppressive therapies.
  • History of allergic reactions to imiquimod or its excipients.
  • Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnancy or lactation.
  • Women of childbearing potential not using a medically acceptable means of contraception.

Sites / Locations

  • NYU Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imiquimod

Arm Description

Each treatment cycle consists of 8 weeks. Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period. Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.

Outcomes

Primary Outcome Measures

Objective Response (Complete Clinical Response+ Partial Response)
This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.

Secondary Outcome Measures

Clinical Benefits
This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.

Full Information

First Posted
May 11, 2009
Last Updated
November 6, 2015
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT00899574
Brief Title
Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
Official Title
Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to determine the safety and efficacy of Imiquimod, a Toll-like receptor 7 agonist in breast cancer (for chestwall recurrences or metastases to the skin).
Detailed Description
TLR agonists are novel agents for cancer therapy which modify the immune response. Imiquimod, a synthetic TLR7 agonist has proven immunomodulatory activity when applied topically, leading to clearance of human papilloma virus (HPV)-induced genital warts and primary skin malignancies. Its effects will now be examined in breast cancer metastatic to the skin. If effective, it will add a relatively non-toxic approach to the treatment armamentarium for this patient population frequently resistant to conventional therapies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Neoplasms
Keywords
toll-like receptor, toll-like receptor agonist, recurrent breast cancer, breast cancer metastasized to skin and/or chestwall, immunomodulator

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Imiquimod
Arm Type
Experimental
Arm Description
Each treatment cycle consists of 8 weeks. Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period. Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.
Intervention Type
Drug
Intervention Name(s)
Imiquimod
Other Intervention Name(s)
Aldara
Intervention Description
Each treatment cycle consists of 8 weeks. Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period. Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease.
Primary Outcome Measure Information:
Title
Objective Response (Complete Clinical Response+ Partial Response)
Description
This is defined as percentage of patients who achieved complete clinical response or partial response at end of cycle 1 of treatment. The tumor size will be measured as lesion surface area (region of interest, ROI). The response to the treatment is then evaluated as a function of post-treatment over pre-treatment ROI, expressed in percentage. Response criteria for this study are based on European Organisation for Research and Treatment of Cancer definitions for chest wall tumors: complete clinical response: absence of any detectable residual disease; partial response: <50% of ROI change.
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Clinical Benefits
Description
This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.
Time Frame
9 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with biopsy-confirmed breast cancer (prior histological documentation is acceptable). Patients with measurable skin metastases (chest wall recurrence and/or non-chest wall skin metastases are eligible). Skin metastases not suitable for or patient refusing definitive surgical resection and radiation. (Cohort 1) Concurrent systemic cancer therapy (hormones, biologics or chemotherapy) is allowed if distant metastases have been non-progressing (stable or responding) on that regimen for > or = 12 weeks and skin metastases are non-responsive (stable or progressing) as assessed by the investigator. (Cohort 2) Any concurrent systemic therapy is allowed Age at least 18 years. Eastern Cooperative Oncology Group (ECOG) performance status < or = 2. Patients must have biopsy-accessible tumor (skin metastases) and agree to biopsies required by protocol. Patients must have adequate organ and bone marrow function as defined below: absolute neutrophil count > or = 1,500/microliter hemoglobin > or = 9.5 grams/deciliter platelets >or = 75,000/microliter total bilirubin < or = 1.5 X institutional upper limit of normal Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) < or = 2.5X institutional upper limit of normal creatinine < or = 1.5 X institutional upper limit of normal Informed consent. Exclusion Criteria: Brain metastases unless resected or irradiated and stable > or = 8 weeks. Treatment with other investigational agents. Patients who have received radiotherapy, high-potency corticosteroids, intralesional therapy, laser therapy or surgery other than biopsy to the target area within 4 weeks prior to first dosing of study agent. Patients who have received hyperthermia to the target area within 10 weeks prior to first dosing of study agent. Patients with an uncontrolled bleeding disorder. Patients who will be therapeutically anticoagulated with heparins or coumadin at the time of the biopsy (they are eligible if anticoagulation can be held prior to biopsy as per investigator). Patients on aspirin and other platelet agents are eligible. Patients with known immunodeficiency or receiving immunosuppressive therapies. History of allergic reactions to imiquimod or its excipients. Uncontrolled intercurrent medical illness or psychiatric illness/social situations that would limit compliance with study requirements. Pregnancy or lactation. Women of childbearing potential not using a medically acceptable means of contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvia Adams, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22767669
Citation
Adams S, Kozhaya L, Martiniuk F, Meng TC, Chiriboga L, Liebes L, Hochman T, Shuman N, Axelrod D, Speyer J, Novik Y, Tiersten A, Goldberg JD, Formenti SC, Bhardwaj N, Unutmaz D, Demaria S. Topical TLR7 agonist imiquimod can induce immune-mediated rejection of skin metastases in patients with breast cancer. Clin Cancer Res. 2012 Dec 15;18(24):6748-57. doi: 10.1158/1078-0432.CCR-12-1149. Epub 2012 Jul 5.
Results Reference
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Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases

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