Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer
NCT ID: NCT00088985
Last Updated: 2017-06-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
56 participants
INTERVENTIONAL
2004-01-31
2009-10-31
Brief Summary
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PURPOSE: This phase II trial is studying how well giving vaccine therapy together with trastuzumab and vinorelbine works in treating women with locally recurrent or metastatic breast cancer.
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Detailed Description
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Primary
* Determine the efficacy of multiepitope autologous dendritic cell vaccine, trastuzumab (Herceptin\^®), and vinorelbine by measuring the change in the largest dimension of metastatic lesions, in women with locally recurrent or metastatic breast cancer that does not overexpress human epidermal growth factor receptor 2 (HER2)/neu.
Secondary
* Determine the ability of this regimen to induce functional antigen-specific T cells in these patients by measuring ex-vivo antigen-specific T-cell activity against peptide-pulsed dendritic cells and tumor targets by tetramer staining and intracellular cytokine assays.
OUTLINE:
* Autologous dendritic cell mobilization and harvest: All patients undergo autologous dendritic cell mobilization with filgrastim (G-CSF) and/or sargramostim (GM-CSF) subcutaneously daily for 4 days followed by apheresis. Mobilized peripheral blood is processed for the production of dendritic cells by cluster of differentiation (CD)34-positive cell selection. The dendritic cells are expanded and then pulsed with E75 and E90 peptides.
* Treatment: Patients receive vinorelbine IV over 6-10 minutes and trastuzumab (Herceptin \^®) IV over 90 minutes on day 1. Patients also receive autologous dendritic cells pulsed with E75 and E90 peptides subcutaneously over 2-5 minutes on day 1\*. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Note: \*If treatment is given locally, the vaccine therapy will be given at University of North Carolina (UNC) -Chapel Hill the following day.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 17-37 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dendritic Cell Vaccine
Dendritic Cells: Dosage: 20 x 106 dendritic cells (DCs) given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly
therapeutic autologous dendritic cells
10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab
4 mg/kg intravenously, every 14 days
vinorelbine ditartrate
Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
Interventions
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therapeutic autologous dendritic cells
10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
trastuzumab
4 mg/kg intravenously, every 14 days
vinorelbine ditartrate
Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed breast cancer
* Locally recurrent or metastatic disease
* HLA-A0201 positive by DNA genotyping
* HER2/neu expression at least 1+ by immunohistochemistry of tumor sample
* Central Nervous System (CNS) metastases allowed provided on therapy for 3 months and stable
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* 18 and over
Sex
* Female
Menopausal status
* Not specified
Performance status
* Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
* Hematocrit \> 33%
Hepatic
* Transaminases ≤ 3 times upper limit of normal
* Bilirubin ≤ 2 times normal
* Hepatitis B surface antigen negative
Renal
* Creatinine \< 2.0 mg/dL
Cardiovascular
* Ejection fraction \> 45% by multigated acquisition scan (MUGA) OR
* Left ventricular function normal by echocardiogram
* No serious cardiac condition that would preclude study participation or compliance
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No serious medical or psychiatric condition that would preclude study participation or compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior biologic therapy allowed
Chemotherapy
* More than 30 days since prior cytotoxic chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* More than 30 days since prior hormonal therapy
* No concurrent hormonal therapy
* No concurrent systemic steroids
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Concurrent bisphosphonates for bone metastases allowed
18 Years
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Susan G. Komen Breast Cancer Foundation
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jonathan S. Serody, MD
Role: STUDY_CHAIR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Countries
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Related Links
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UNC Lineberger Comprehensive Cancer Center
Other Identifiers
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