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

NCT00899574 | Completed Phase 2 Results DMC

• 1 other identifier: NYU 09-0225
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Breast Neoplasms

Keywords

toll-like receptor; toll-like receptor agonist; recurrent breast cancer; breast cancer metastasized to skin and/or chestwall; immunomodulator

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Secondary Outcomes (1)

• Clinical Benefits

  9 weeks

Study Arms (1)

Imiquimod

EXPERIMENTAL

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.

Drug: Imiquimod

Interventions

Imiquimod DRUG

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.

Also known as: Aldara

Imiquimod

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 22767669 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The 20% response rate would have justified to continue; but the study was concluded and a new trial of imiquimod and local radiotherapy (NCT01421017) is open, based on preclinical findings indicating that the combination was more effective.

Results Point of Contact

• Title: Sylvia Adams, MD
• Organization: NYU Cancer Institute

sylvia.adams@nyumc.org

212-263-6485

Study Officials

• Sylvia Adams, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2013
• Last Updated: December 7, 2015
• Results First Posted: May 11, 2012

Record last verified: 2015-11

Locations

US (1)