Status:
COMPLETED
Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Male Breast Cancer
Recurrent Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying the side effects of giving topical imiquimod together with Abraxane (paclitaxel albumin-stabilized nanoparticle formulation) to see how well it works in treating patien...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the safety of chemoimmunotherapy with topical imiquimod and Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous metastasis. II. To ev...
Eligibility Criteria
Inclusion
- Patients with advanced stage refractory breast cancer
- Progressive or relapsed disease following standard therapy with chemotherapy and/or surgery, and/or radiation
- Patients must have measurable (bi-dimensional) chest wall disease and/or cutaneous metastatic lesions
- Patients must be at least 7 days from last chemotherapy and 30 days from local radiotherapy and/or systemic steroids
- Patients on bisphosphonates, trastuzumab, lapatinib and/or hormonal therapy are eligible
- White blood cell count \>= 1000/ul
- Absolute neutrophil count (ANC) \>= 1200/ul
- Platelets \> 75,000/ul
- Serum creatinine =\< 2.0 mg/dL, a creatinine clearance \> 60 ml/min
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2 X upper limit normal (ULN)
- Total bilirubin \< 2 X ULN
- Patients must have a Performance Status Score (Eastern Cooperative Oncology Group \[ECOG\] Scale) =\< 2
- Patients must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment
- Men and women of reproductive ability must agree to contraceptive use during the study and for 1 month after imiquimod/Abraxane treatment is discontinued
Exclusion
- Patients with prior allergic reaction to taxanes
- Patients with any clinically significant active autoimmune disease requiring active treatment with systemic steroids or other immunomodulators
- Pregnant or breast-feeding women
- Patients with peripheral neuropathy \>= Grade 2
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00821964
Start Date
December 1 2008
End Date
November 29 2012
Last Update
January 2 2018
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109