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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00899574
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : May 11, 2012
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Tracking Information
First Submitted Date  ICMJE May 11, 2009
First Posted Date  ICMJE May 12, 2009
Results First Submitted Date  ICMJE April 12, 2012
Results First Posted Date  ICMJE May 11, 2012
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE May 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2012)
Objective Response (Complete Clinical Response+ Partial Response) [ Time Frame: 9 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
objective response rate [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2012)
Clinical Benefits [ Time Frame: 9 weeks ]
This outcome measure is defined as number of patients with improvement of symptoms after 8 weeks of treatment.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2009)
  • biological activities of Imiquimod [ Time Frame: 12 weeks ]
  • toxicity rate [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
Official Title  ICMJE Phase II Evaluation of Imiquimod, a Topical Toll-like Receptor 7 (TLR7) Agonist in Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Breast Neoplasms
Intervention  ICMJE Drug: Imiquimod

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.

Other Name: Aldara
Study Arms  ICMJE Experimental: Imiquimod

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: Drug: Imiquimod
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2011)
10
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2009)
29
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00899574
Other Study ID Numbers  ICMJE NYU 09-0225
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NYU Langone Health
Study Sponsor  ICMJE NYU Langone Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sylvia Adams, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP