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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: | NCT00791037 |
RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress HER2.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy in treating patients with stage IV breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: HER-2/neu peptide vaccine Drug: cyclophosphamide Drug: ex vivo-expanded HER2-specific T cells Drug: sargramostim Drug: trastuzumab Procedure: flow cytometry Procedure: gene expression analysis Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: leukapheresis Procedure: polymerase chain reaction |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Phase I/II Study of Adoptive T Cell Therapy Following In Vivo Priming With a HER-2/Neu (HER2) Intracellular Domain (ICD) Peptide-Based Vaccine in Patients With Advanced Stage HER2 Overexpressing Breast Cancer |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a dose-escalation study of ex vivo-expanded HER2-specific autologous T cells.
Patients receive HER-2/neu peptide vaccine admixed with sargramostim (GM-CSF) intradermally on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.
Patients receive cyclophosphamide IV on day -1 and autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on day 1. Treatment repeats every 7-10 days for a total of three immunizations. Patients receive a booster vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.
Patients may continue trastuzumab (Herceptin®) IV weekly or every 3 weeks, except for 7 days before the cyclophosphamide dose.
Blood samples are obtained at baseline and then periodically during and after treatment. T-cell responses are analyzed periodically utilizing ELISPOT and cytokine flow cytometry, FOXP3 gene expression is assessed by PCR, and cytokine and chemokine levels are measured.
After completion of study therapy, patients are followed every 3 months for 1 year and then every 4 months for 1 year. Continued analysis for T-cell persistence is offered to the patients twice a year thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of breast cancer
Previously treated disease
Measurable disease, defined as stable disease, while receiving trastuzumab (Herceptin®) and/or hormonal therapy or bisphosphonates
History of brain metastases must have a stable head imaging study within 30 days of enrollment
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Concurrent trastuzumab, hormonal therapy, and/or bisphosphonates allowed
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Clinical Trials Office - Fred Hutchinson Cancer Research Cente 800-804-8824 |
Principal Investigator: | Mary (Nora) L. Disis, MD | University of Washington |
Responsible Party: | University of Washington School of Medicine ( Mary (Nora) L. Disis ) |
Study ID Numbers: | CDR0000618560, UWCC-6658, IR-6658 |
Study First Received: | November 13, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00791037 |
Health Authority: | Unspecified |
male breast cancer recurrent breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms, Male Trastuzumab Breast Neoplasms |
Cyclophosphamide Breast Diseases Recurrence |
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms |
Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |