Status:
COMPLETED
Imiquimod for Breast Cancer Patients With Chest Wall Recurrence or Skin Metastases
Lead Sponsor:
NYU Langone Health
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00899574
Start Date
May 1 2009
End Date
June 1 2013
Last Update
December 7 2015
Active Locations (1)
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1
NYU Cancer Institute
New York, New York, United States, 10016