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

PHASE2CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

February 28, 2013

Study Completion Date

October 27, 2017

Conditions
Breast Cancer
Interventions
BIOLOGICAL

sargramostim

All patients will receive Leukine (GM-CSF) at 250 mcg/m2 starting one day after the administration of chemotherapy x 7 days. Patients with neutrophil counts below 1,000/mm3 on day 8 will continue GM-CSF therapy until the neutrophil count is greater than 1,000/mm3.

BIOLOGICAL

therapeutic autologous dendritic cells

patients will receive (10 x 106) peptide-pulsed DCs given by i.d injection into either axilla or the inguinal region with each peptide given into a separate site. The total dose will be 20 x 106 DCs given per treatment.

BIOLOGICAL

trastuzumab

Trastuzumab will be infused in the side-port of a freely flowing IV over 90 minutes and at 6mg/kg if the subject has not previously received Trastuzumab, or if it has been more than 30 days since any prior trastuzumab administration. If the subject has previously received Trastuzumab within 30 days and has no adverse history with the drug, the infusion will be given over 30 minutes. If the subject is currently receiving Trastuzumab, the first study infusion will be given at 4mg/kg over 30 minutes. Subsequently, Trastuzumab will be infused at 4 mg/kg in the side-port of a freely flowing IV over 30 minutes.

DRUG

vinorelbine ditartrate

Vinorelbine 25 mg/m2 will be administered IV over six to ten minutes into the side port of a freely flowing IV line.

Trial Locations (1)

27599-7295

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Susan G. Komen Breast Cancer Foundation

OTHER

lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT00266110 - Vaccine Therapy, Trastuzumab, and Vinorelbine in Treating Patients With Locally Recurrent or Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter