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Title
A Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases
 
Study Design
Imiquimod: Topical application of 5% imiquimod cream to target skin and/or chest wall lesions

Abraxane: Intravenous chemotherapy infusions over 30 minutes at a dose of 100 mg/m2
 
Study Contact
Stephanie Parker | 866.932.8588 | E-Mail
 
Patient Population

  1. Advanced-stage breast cancer
  2. Skin and/or chest wall metastases that are no longer responding to standard therapy
Number of Patients: This study will accrue a maximum of 15 patients.
 
Patients Visits

  1. Up to three 28-day treatment cycles:
    • Imiquimod application to skin on Days 1-4, 8-12, 15-18, and 22-25
    • Abraxane chemotherapy by IV infusion on Days 1, 8, and 15
  2. Follow-up visits:
    • 1, 4, 8 and 12 weeks after last treatment cycle
  3. Total visits: up to 16
Other Procedures

  1. History & Physical exams
  2. Blood tests
  3. Research blood draws
  4. Pregnancy test (if applicable)
  5. Measurement of skin lesions by size and photography
  6. Skin punch biopsies of cancer lesions
  7. CT scans (if cancer is other places than the skin or chest wall)
Objectives
Primary:
  1. Evaluate the safety of study treatment
  2. Determine the anti-tumor effects of study treatment
Secondary:
  1. Determine whether study treatment improves tumor-specific immunity
  2. Assess the effects of study treatment on circulating tumor growth factor beta (TGF-B) levels
Other Notes
Imiquimod is FDA-Approved
Topical imiquimod is approved by the FDA for the treatment of external genital warts, difficult-to-treat common warts, and superficial basal cell carcinoma. It may also be used for other purposes.
Abraxane™ is FDA-Approved
Abraxane™ is a newer version of paclitaxel, a drug approved by the FDA for the treatment of metastatic breast cancer.
 
Start Date: February 2009
 
Study Location: University of Washington Medical Center | 1959 NE Pacific Street | Seattle, WA 98195
 
Current Enrollment: 0%
 
Scientific Description
 
ClinicalTrials.gov Identifier: NCT00821964
 
Page last updated 01/26/2012