Status:
COMPLETED
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Susan G. Komen Breast Cancer Foundation
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 recurr...
Eligibility Criteria
Inclusion
- PATIENT ELIGIBILITY
- 1 Inclusion Criteria 4.1.1 Histologically proven metastatic breast cancer with measurable or evaluable disease per investigator discretion.
- 1.2 Patients must be 18 years of age or older. Women of child bearing potential must be practicing barrier or oral contraception for the duration of the study, or documented as surgically sterile or one year post-menopausal.
- 1.3 Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (See Appendix A).
- 1.5 Cardiac function by multigated acquisition scan (MUGA) with an ejection fraction (EF) \> 45% or an echocardiogram that shows normal left ventricle (LV) function.
- 1.6 Serum Creatinine \< 2.0 mg/dl. 4.1.7 Hepatic transaminases (alanine aminotransferase (ALT) and aspartate aminotransferase (AST)) ≤3.0 times the upper limit of normal if no liver metastases or ≤5 times the upper limit of normal if liver metastases are present.
- 1.8 Bilirubin no more than 2 times normal.
- 1.9 Seronegative for HIV.
- 1.10 Negative for Hepatitis B surface antigen.
- 1.11 Signed and dated informed consent.
- 1.12 HLA A0201+ by DNA genotyping.
- 1.13 Absolute neutrophil count greater than 1,500/mm3. Platelet count greater 100,000/mm3 and hemoglobin greater than or equal to 10
- 1.14. 3+ expression of HER-2/neu from original pathology (diagnostic) tumor sample by Immunohistochemistry (IHC) or 2+ expression by IHC with gene amplification by fluorescence in situ hybridization (FISH).
- 1.15. Patients will be eligible even if they have failed treatment for metastatic breast cancer with trastuzumab and a chemotherapy agent other than vinorelbine or if they have progressed within 12 months of receiving adjuvant chemotherapy using trastuzumab and a taxane.
- 2 Exclusion Criteria
- 2.1 Patients with any serious medical, cardiac, or psychiatric condition which, in the opinion of the investigator, would make the patient unsuitable for study participation or would impede probable compliance with the protocol.
- 2.2 Patients with central nervous system metastases must have stable disease for at least 3 months prior to study entry.
- 2.3 Patient is currently taking steroid medications. Systemic steroid treatment is not allowed.
- 2.4 Patients that have failed prior therapy with vinorelbine + trastuzumab will not be eligible for therapy.
- 2.5 Patient has received hormonal or cytotoxic chemotherapy within 14 days of apheresis and within 28-30 days prior to study treatment.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2017
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00266110
Start Date
December 1 2005
End Date
October 27 2017
Last Update
September 12 2018
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295