OncRef

Clinical Trial: NCT02780401

Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:University of Washington
Information Provided By:University of Washington
Last Update Posted:2024-09-19

Study Overview

Brief Summary

This phase I trial studies the side effects and best dose of a vaccine therapy in preventing cancer from coming back in patients with non-metastatic, node positive, human epidermal growth factor receptor (HER)2 negative breast cancer in which all signs and symptoms have disappeared. Vaccines made from deoxyribonucleic acid (DNA) may help the body build an effective immune response to kill tumor cells. Giving multiple vaccinations may make a stronger immune response and prevent or delay the return of cancer.

Official Title

A Phase I Trial of the Safety and Immunogenicity of a DNA Plasmid Based Vaccine (WOKVAC) Encoding Epitopes Derived From Three Breast Cancer Antigens (IGFBP-2, HER2, and IGF-1R) in Patients With Breast Cancer

Conditions

HER2/Neu Negative, No Evidence of Disease, One or More Positive Axillary Nodes, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment

  • Other: Laboratory Biomarker Analysis
  • Biological: pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
  • Biological: Sargramostim

Other Study ID Numbers

  • 9626
  • NCI-2016-00581
  • UW14090
  • N01-CN-2012-00033
  • UWI4090
  • UWI2014-03-01
  • N01CN00033
  • P30CA014520
  • RG1716053

Start Date (Actual)

2016-09-02

Primary Completion Date (Actual)

2020-10-08

Study Completion Date (Actual)

2022-10-08

Enrollment (Actual)

32

Study Type

Interventional

Phase

Phase 1