Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Women With Locally Recurrent or Metastatic Breast Cancer

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT00088985
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • therapeutic autologous dendritic cells — BIOLOGICAL
    10 μg/kg subcutaneously (sc) each day for four days or g-CSF at 5 μg/kg sc each day for four days with GM-CSF 250 μg/m2 sc each day for four days. G-CSF and/or GM- CSF will be self-administered. On the fifth day patients will have two intravenous lines placed in the apheresis area of the Blood Bank and then undergo a 15 litre apheresis collection
  • trastuzumab — BIOLOGICAL
    4 mg/kg intravenously, every 14 days
  • vinorelbine ditartrate — DRUG
    Vinorelbine 25 mg/m2 will be administered intravenously, every 14 days

Study Details

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.

Key Dates

Start date
Jan 31, 2004
Status verified
May 2017
Primary completion
Oct 31, 2009
Completion
Oct 31, 2009

Study Design

Enrollment
56 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dendritic Cell Vaccine
    Dendritic Cells: Dosage: 20 x 106 dendritic cells (DCs) given per treatment Vinorelbine:25 mg/m2 will be administered i.v biweekly Trastuzumab: 6mg/Kg administered by i.v. biweekly

Primary Outcome Measure

Overall Response Rate [ Time Frame: 6 months following treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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