Protocol 138

Protocol 138

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 

Patient Population

Main Criteria Only

Inclusion criteria

  • Patients with non-metastatic, node positive, HER2 negative breast cancer, who are in remission and defined as having no evidence of disease (NED)
  • Patients must be at least 28 days post cytotoxic chemotherapy, radiotherapy, monoclonal antibody and/or other biologic therapy, prior to enrollment
    • Bisphosphonates, Xgeva and endocrine therapy are allowed
  • Patients must be at least 28 days post systemic steroids prior to enrollment
  • Adequate labs within 90 days of first vaccination

Exclusion criteria

  • Patients with certain heart problems
  • Patients with a history of diabetes
  • Patients with a known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
  •  History of autoimmunity that has not been controlled with treatment

 

Number of patients

  • 30 patients with non-metastatic, node positive, HER2 negative breast cancer who are in remission and defined as no evidence of disease (NED)

Study Objectives

Primary objective

  • Determine the safety of up to 3 escalating doses of WOKVAC

Secondary objective

  • Determine the immunogenicity of WOKVAC at 3 escalating doses

Treatment Information

Patients will be assigned to 1 of 3 arms. Patients will be assigned to each arm sequentially with patients being accrued to Arm 1 first (150 mcg), then Arm 2 (300mcg), then Arm 3 (600mcg) (if Arm 2 is as safe and immunogenic as Arm 1)

Study Treatment

  • WOKVAC vaccines once a month the first three months
  • MUGA or ECHO before your first vaccination, one month after the first vaccine and one month after your last (3rd) vaccination
  • Post vaccine follow-up visits at 1 month and 6 months after the last vaccine.
  • Clinic notes will be collected from the primary oncologist yearly for 5 years from enrollment to obtain information about your overall health and any potential side effects from the vaccine

Study Location

University of Washington Medical Center  | 1959 NE Pacific Street  | Seattle, WA 98195

ClinicalTrials.gov Identifier: NCT02780401

Contact Information

Phone: 866-932-8588

Email: cvitrial@uw.edu

 

Clinical Trials Contact

For more information regarding our trials, please call our Patient Coordinator

866-932-8588
Email