Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Trial Evaluating The Efficacy Of A Multiepitope Dendritic Cell Vaccine Given With Trastuzumab And Vinorelbine For The Treatment Of Women With Metastatic Breast Cancer That Express HLA-A0201
OBJECTIVES:
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 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 CD34-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 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
- 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
- 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 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Description:
Response measured by RECIST criteria
Outcome Time Frame:
6 months following treatment
Safety Issue:
No
Principal Investigator
Jonathan S. Serody, MD
Investigator Role:
Study Chair
Investigator Affiliation:
UNC Lineberger Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
LCCC 0310
NCT ID:
NCT00088985
Start Date:
January 2004
Completion Date:
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
