Status:
TERMINATED
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women 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:
FEMALE
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing subst...
Detailed Description
OBJECTIVES: Primary * Determine the efficacy of multiepitope autologous dendritic cell vaccine, trastuzumab (Herceptin\^®), and vinorelbine by measuring the change in the largest dimension of metast...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00088985
Start Date
January 1 2004
End Date
October 1 2009
Last Update
June 20 2017
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