Overview

This trial is active, not recruiting.

Conditions male breast cancer, recurrent breast cancer, skin metastases, stage iv breast cancer
Treatments imiquimod, abraxane, laboratory biomarker analysis, rna analysis, immunoenzyme technique
Phase phase 2
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date December 2008
End date January 2013
Trial size 15 participants
Trial identifier NCT00821964, 131, 6578, NCI-2010-00040, R01CA138521

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients receive Abraxane IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions 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.
imiquimod Aldara
Given topically
abraxane Albumin-Stabilized Nanoparticle Paclitaxel
Given IV
laboratory biomarker analysis
Correlative studies
rna analysis
Correlative studies
immunoenzyme technique immunoenzyme techniques
Correlative studies

Primary Outcomes

Measure
Anti-tumor effects of imiquimod as assessed by modified World Health Organization (WHO) criteria
time frame: Baseline and then every 4 weeks until week 24
Safety and systemic toxicity as assessed by a review of medical history, physical exam, systems, performance status, and clinical labs (CBC and CMP)
time frame: Baseline and weeks 5, 9 13, 16, 20, and 24
Pathologic response as assessed by skin punch biopsy
time frame: Pre-and post-treatment

Secondary Outcomes

Measure
Endogenous immunity to common breast tumor antigens (HER2, IGFBP-2, Topoisomerase II-alpha, and p53) in peripheral blood as assessed by IFN-gamma and ELISPOT assay
time frame: Baseline and at weeks 13 and 24
Incidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response
time frame: Baseline and at weeks 13 and 24

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 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 Criteria: - 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

Additional Information

Official title Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases
Principal investigator Lupe Salazar
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Washington.