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

NCT02780401 | Completed Phase 1 Results DMC FDA Drug

• 9 other identifiers: 9626NCI-2016-00581UW14090N01-CN-2012-00033UWI4090UWI2014-03-01N01CN00033P30CA014520RG1716053
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

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

Keywords

Stage I; Stage II; Stage III

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0

  Toxicities by grade that were related (possibly, probably or definitely) to the study vaccine noted during the immunization regimen will be summarized. This is done by arm, Grade and Attribution to study vaccine.

  Up to 9 months

Secondary Outcomes (6)

• Assessment of IgG Antibodies

  Up to 4 months

• Assessment of T Helper Th1:Th2 Ratio

  Up to 9 months

• Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells

  Up to 24 weeks

• Level of Antigen Specific Central and Effector Memory Phenotypes (Persistent Memory T Cell Response)

  Up to 6 months after the last vaccine

• Modulation of Myeloid Derived Suppressor Cell Levels

  Up to 24 weeks

Study Arms (1)

Treatment (WOKVAC with sargramostim)

EXPERIMENTAL

Patients receive WOKVAC with sargramostim 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 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.

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

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (WOKVAC with sargramostim)

pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine BIOLOGICAL

Given ID

Also known as: pUMVC3-IGFBP2-HER2-IGF1R, pUMVC3-IGFBP2-HER2-IGF1R Vaccine, WOKVAC, WOKVAC Vaccine

Treatment (WOKVAC with sargramostim)

Sargramostim BIOLOGICAL

Given ID

Also known as: 23-L-Leucinecolony-Stimulating Factor 2, DRG-0012, Leukine, Prokine, rhu GM-CFS, Sagramostim, Sargramostatin

Treatment (WOKVAC with sargramostim)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED); HER2 negative is defined as
• + HER2 expression by immunohistochemistry (IHC) OR
• Fluorescence in situ hybridization (FISH) negative OR
• HER2 2+ and FISH negative
• Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment; patients on bisphosphonates, denosumab, and/or endocrine therapy administered during the study are eligible and may continue throughout duration of study
• Patients must be at least 28 days post systemic steroids prior to enrollment
• Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 2
• White blood cell (WBC) \>= 3000/mm\^3
• Hemoglobin (Hgb) \>= 10 g/dl
• Lymphocyte count \>= 800/mm\^3
• Platelet count \>= 75,000/mm\^3
• Serum creatinine =\< 2.0 mg/dl or creatinine clearance \> 60 ml/min
• Total bilirubin =\< 1.5 mg/dl
• Aspartate aminotransferase (AST)/Serum glutamic oxaloacetic transaminase (SGOT) =\< 2 times upper limit of normal (ULN)
• Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment

You may not qualify if:

• Patients with any of the following cardiac conditions:
• Symptomatic restrictive cardiomyopathy
• Dilated cardiomyopathy
• Unstable angina within 4 months prior to enrollment
• New York Heart Association functional class III-IV heart failure on active treatment
• Symptomatic pericardial effusion
• Patients may not be receiving any other investigational agents
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to WOKVAC
• Patients with any contraindication or known hypersensitivity to receiving sargramostim (recombinant human granulocyte macrophage colony stimulating factor \[rhuGM-CSF\]) or other yeast based products
• Pregnant women are excluded from this study because WOKVAC is a vaccine agent with unknown potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with WOKVAC breastfeeding should be discontinued if the mother is treated with this vaccine
• History of diabetes
• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
• History of autoimmunity that has not been controlled with treatment in the last 12 months

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator
• University of Wisconsin, Madison: collaborator

Study Sites (2)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Disis ML, Gad E, Herendeen DR, Lai VP, Park KH, Cecil DL, O'Meara MM, Treuting PM, Lubet RA. A multiantigen vaccine targeting neu, IGFBP-2, and IGF-IR prevents tumor progression in mice with preinvasive breast disease. Cancer Prev Res (Phila). 2013 Dec;6(12):1273-82. doi: 10.1158/1940-6207.CAPR-13-0182. Epub 2013 Oct 23.

  PMID: 24154719 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sargramostim; Colony-Stimulating Factors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Jennifer S. Childs
• Organization: University of Washington Medical Center

childj@u.washington.edu

2066162305

Study Officials

• Kari Wisinski

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Clinical Research Division

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 23, 2016
• Study Start: September 2, 2016
• Primary Completion: October 8, 2020
• Study Completion: October 8, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)