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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00821964 |
RATIONALE: Biological therapies, such as imiquimod, may stimulate the immune system to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, 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 paclitaxel albumin-stabilized nanoparticle formulation may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects of giving topical imiquimod together with paclitaxel albumin-stabilized nanoparticle formulation and to see how well it works in treating patients with advanced breast cancer.
Condition | Intervention | Phase |
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Breast Cancer Metastatic Cancer |
Drug: imiquimod Drug: paclitaxel albumin-stabilized nanoparticle formulation Genetic: RNA analysis Other: immunoenzyme technique Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Phase II Study of Topical Imiquimod and Weekly Abraxane for the Treatment of Breast Cancer Cutaneous Metastases |
Estimated Enrollment: | 15 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15 and apply topical imiquimod to cutaneous lesions once daily on days 1-4, 8-12, 15-18, and 22-25. Treatment repeats every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline, after course 3, and after completion of the study for correlative immunological analyses. Samples are assessed for endogenous immunity to common breast tumor antigens (i.e., HER2, IGFBP-2, topoisomerase II-α, and p53) by IFN-γ ELISPOT, circulating TGF-β levels by ELISA, and global mRNA expression by RNA analysis. Patients also undergo measurement, photo documentation, and punch biopsies of cutaneous lesions of lesions periodically for evaluation of response.
After completion of study treatment, patients are followed at 4, 8, and 12 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Nicole Bates 206-543-6620 |
Principal Investigator: | Lupe G. Salazar, MD | Fred Hutchinson Cancer Research Center |
Responsible Party: | Fred Hutchinson Cancer Research Center ( Lupe G. Salazar ) |
Study ID Numbers: | CDR0000632200, UWCC-6578, FHCRC-6578, IR-6578 |
Study First Received: | January 13, 2009 |
Last Updated: | April 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00821964 History of Changes |
Health Authority: | Unspecified |
stage IV breast cancer recurrent breast cancer skin metastases male breast cancer |
Skin Diseases Immunologic Factors Interferons Adjuvants, Immunologic Breast Neoplasms Imiquimod Antimitotic Agents Breast Cancer, Male |
Recurrence Breast Neoplasms, Male Paclitaxel Tubulin Modulators Neoplasm Metastasis Antineoplastic Agents, Phytogenic Breast Diseases |
Interferon Inducers Molecular Mechanisms of Pharmacological Action Immunologic Factors Skin Diseases Antineoplastic Agents Mitosis Modulators Physiological Effects of Drugs Adjuvants, Immunologic Breast Neoplasms Imiquimod Antimitotic Agents |
Pharmacologic Actions Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Paclitaxel Therapeutic Uses Tubulin Modulators Neoplasm Metastasis Antineoplastic Agents, Phytogenic Breast Diseases |