Topical Imiquimod and Abraxane in Treating Patients With Advanced Breast Cancer
Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Male Breast Cancer; Recurrent Breast Cancer; Skin Metastases; Stage IV Breast Cancer
Intervention: imiquimod (Drug); Abraxane (Drug); laboratory biomarker analysis (Other); RNA analysis (Genetic); immunoenzyme technique (Other)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: University of Washington Official(s) and/or principal investigator(s): Lupe Salazar, Principal Investigator, Affiliation: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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.
Clinical Details
Official title: Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Anti-tumor effects of imiquimod as assessed by modified World Health Organization (WHO) criteriaSafety and systemic toxicity as assessed by a review of medical history, physical exam, systems, performance status, and clinical labs (CBC and CMP) Pathologic response as assessed by skin punch biopsy
Secondary outcome: 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 assayIncidence of reduction of serum TGF-beta levels as assessed by ELISA and correlation with Th1 adaptive immunity and clinical response
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington 98109, United States
Additional Information
Starting date: December 2008
Last updated: August 10, 2015
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