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Vaccine Therapy in Treating Patients With Stage IV Breast Cancer

NCT00791037 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2017-05-25

Study results available
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Summary

This phase I/II trial is studying the side effects of escalating doses of adoptive T cell therapy in treating patients with stage IV breast cancer. Vaccines are given to patient prior the expansion of a person's white blood cells may help the body build an effective immune response to kill tumor cells that overexpress human epidermal growth factor receptor 2 (HER2)

Conditions

Interventions

BIOLOGICAL

HER-2/neu peptide vaccine

Given ID

PROCEDURE

leukapheresis

Undergo leukapheresis

BIOLOGICAL

ex vivo-expanded HER2-specific T cells

Given IV

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

sargramostim

Given ID

OTHER

laboratory biomarker analysis

Correlative study

Sponsors & Collaborators

Principal Investigators

  • Mary Disis · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-07-31
Completion
2014-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00791037 on ClinicalTrials.gov