Last updated on March 2019

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


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To assess the safety of 3 escalating doses of a deoxyribonucleic acid (DNA) plasmid based vaccine encoding three breast cancer antigens (insulin-like growth factor-binding protein [IGFBP]-2, HER2, and insulin-like growth factor [IGF]-1 receptor [1R]) in patients with breast cancer.

SECONDARY OBJECTIVES:

I. To determine the immunogenicity of pUMVC3-IGFBP2-HER2-IGF1R (WOKVAC) T helper cells (Th) polyepitope plasmid based vaccine in patients with breast cancer at 3 escalating doses.

II. To determine whether a WOKVAC Th polyepitope plasmid based vaccine elicits a persistent memory T cell response.

III. To evaluate whether WOKVAC vaccination modulates T regulatory cells (Treg) and myeloid derived suppressor cells (MDSC).

IV. To evaluate changes in mammographic density using clinically available images prior to baseline and post vaccination as an exploratory analysis.

V. To determine a recommended phase 2 WOKVAC dose for further breast cancer prevention studies.

OUTLINE: This is a dose escalation study of WOKVAC.

Patients receive WOKVAC with sargramostim intradermally (ID) on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients with axillary lymph node dissection (ALND) will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.

After completion of study treatment, patients are followed up at 1 month, 6 months and annually for up to 5 years thereafter.

Clinical Study Identifier: NCT02780401

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Recruitment Status: Open


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