drugset / Trial / NCT00088985
Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer
Phase 2
Terminated
56 enrolled
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI) · collabSusan G. Komen Breast Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
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 substances to them without harming normal cells. Drugs used in chemotherapy, such as vinorelbine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with monoclonal antibody therapy and chemotherapy 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 women with locally recurrent or metastatic breast cancer.
Timeline
- Start
- 2004-01
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trastuzumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Vinorelbine | Small molecule | 25 mg/m2 | Intravenous |
| Subject | therapeutic autologous dendritic cells | Vaccine | 2e+07 cells | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Background | sargramostim | Protein / enzyme biologic | 250 ug/m2 | Subcutaneous |