Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: sargramostim (Drug); therapeutic autologous dendritic cells (Drug); trastuzumab (Drug); vinorelbine ditartrate (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: UNC Lineberger Comprehensive Cancer Center Official(s) and/or principal investigator(s):
Jonathan S. Serody, MD, Principal Investigator, Affiliation: UNC Lineberger Comprehensive Cancer Center
Summary
RATIONALE: Vaccines made from a person's white blood cells may help the body build an
effective immune response to kill tumor cells. Monoclonal antibodies, such as trastuzumab,
can block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop the growth of
tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine
therapy together with trastuzumab and vinorelbine may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with
trastuzumab and vinorelbine works in treating patients with locally recurrent or metastatic
breast cancer.
Clinical Details
Official title: Phase II Trial Evaluating the Toxicity and Efficacy of a Multiepitope Dendritic Cell Vaccine Given With Trastuzumab and Vinorelbine Ditartrate for the Treatment of Women With Metastatic Breast Cancer That Express HLA-A0201 and Whose Tumors Overexpress HER-2/NEU
Study design: Treatment, Open Label
Primary outcome: Efficacy
Secondary outcome: Generation of functional antigen-specific T cells
Detailed description:
OBJECTIVES:
Primary
- Determine the efficacy of multiepitope autologous dendritic cell vaccine in combination
with trastuzumab (Herceptin®) and vinorelbine ditartrate in patients with locally
recurrent or metastatic breast cancer whose tumors overexpress HER2/neu.
Secondary
- Determine if this regimen is effective in generating functional antigen-specific T
cells.
OUTLINE:
- Therapeutic autologous dendritic cell (DC) preparation: Patients undergo mobilization of
DC and apheresis for production of therapeutic DC. DCs are expanded in vitro for 10-20
days and pulsed with E75 and E90 peptides.
- Treatment: Patients receive vinorelbine ditartrate IV over 6-10 minutes, therapeutic
autologous DC intradermally over 2-5 minutes, and trastuzumab (Herceptin®) IV over 30-90
minutes on day 1. Patients receive sargramostim (GM-CSF) subcutaneously on days 2, 4,
and 6, or until neutrophil counts recover. Treatment repeats every 14 days for up to 6
courses (or more at the discretion of the investigator) in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Locally recurrent or metastatic disease
- Measurable or evaluable disease
- Must have HER2/neu overexpression, defined as 3+ overexpression by IHC OR 2+
overexpression by IHC with gene amplification by FISH
- HLA-A0201-positive by DNA genotyping
- Failure of prior treatment with trastuzumab (Herceptin®) and a chemotherapy agent for
metastatic breast cancer OR disease progression within 12 months of receiving adjuvant
chemotherapy comprising trastuzumab and a taxane allowed
- Must not have failed prior therapy with vinorelbine ditartrate and trastuzumab
- CNS metastases allowed provided disease has been stable for the past 3 months
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female or male
- Menopausal status not specified
- ECOG performance status 0-2
- ANC > 1,500/mm³
- Platelet count > 100,000/mm³
- Hematocrit > 33%
- Creatinine < 2. 0 mg/dL
- AST and ALT ≤ 3 times upper limit of normal (ULN)
- Bilirubin ≤ 2 times ULN
- HIV negative
- Hepatitis B surface antigen-negative
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- LVEF > 45% by MUGA or echocardiogram
- No serious medical, cardiac, or psychiatric condition that, in the opinion of the
investigator, would preclude study compliance
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 30 days since prior and no other concurrent cytotoxic chemotherapy or
hormonal therapy
- Concurrent bisphosphonates allowed for patients with a history of metastatic disease
to bone
- No other concurrent therapy for progressive disease
- No concurrent systemic steroids
Locations and Contacts
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States; Recruiting
Clinical Trials Office - Lineberger Comprehensive Cancer Cente, Phone: 877-668-0683; 919-966-4432
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: December 2005
Last updated: October 22, 2008
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