NCT00821964

Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer

Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patients with advanced breast cancer. Biological therapies, such as imiquimod, may stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as Abraxane, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving imiquimod together with Abraxane may kill more tumor cells.

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 evaluate the anti-tumor effects of chemoimmunotherapy with topical imiquimod and Abraxane in breast cancer patients with recurrent chest wall disease or cutaneous metastasis. SECONDARY OBJECTIVES: I. To examine whether treatment with chemoimmunotherapy consisting of topical imiquimod and Abraxane augments endogenous tumor specific immunity. II. To assess the effect of chemoimmunotherapy on circulating transforming growth factor (TGF)-beta levels. OUTLINE: Patients receive Abraxane intravenously (IV) over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions once daily (QD) on days 1-4, 8-11, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1, 4, 8, and 12 weeks.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Skin Metastases
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	imiquimod	Given topically
DRUG	Abraxane	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
GENETIC	RNA analysis	Correlative studies
OTHER	immunoenzyme technique	Correlative studies

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-11-01
• Completion: 2012-11-29
• First posted: 2009-01-14
• Last updated: 2018-01-02
• Results posted: 2017-06-28

Locations

1 site across 1 country: United States