Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02780401
Study type Interventional
Source University of Washington
Contact
Status Active, not recruiting
Phase Phase 1
Start date September 2, 2016
Completion date March 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT02235051 - Exercise Intervention in Preventing Breast Cancer Recurrence in Postmenopausal Breast Cancer Survivors N/A
Terminated NCT02454777 - High-Intensity Interval Training for Stage I-III Breast Cancer Patients N/A
Completed NCT03061175 - Web-Based Decision Aid in Improving Informed Decisions in Patients With Stage 0-IIIA Breast Cancer Considering Contralateral Prophylactic Mastectomy N/A
Completed NCT01959490 - Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer Phase 2
Recruiting NCT03156309 - Vaccine Therapy in Preventing Cancer Recurrence in Patients With Non-Metastatic, Node Positive, HER2 Negative Breast Cancer That is in Remission Phase 1
Terminated NCT01368263 - Goserelin and Letrozole or Anastrozole in Premenopausal Patients With Stage II-III Estrogen Receptor-Positive Breast Cancer Phase 2
Completed NCT01928186 - FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer N/A
Terminated NCT01222377 - Endoscopic Breast Surgery in Treating Patients With Breast Cancer N/A
Completed NCT00425672 - ONTAK® in Treating Patients With Advanced Breast Cancer That Did Not Respond to Previous Treatment Phase 1/Phase 2
Completed NCT00070252 - Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer Phase 1/Phase 2
Completed NCT02728596 - S1415CD, Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER) N/A
Completed NCT01478477 - Omega-3 Fatty Acids in Preventing Joint Symptoms in Patients With Stage I-III Breast Cancer Receiving Anastrozole, Exemestane, or Letrozole N/A
Completed NCT03364348 - 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer Phase 1
Completed NCT02897375 - Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors Phase 1
Withdrawn NCT01695057 - Vorinostat Before Surgery in Treating Patients With Triple-Negative Breast Cancer N/A
Completed NCT01672684 - Phase I: At-Home Support for Rural Women Using Group Video Calling Phase 1
Terminated NCT01233505 - Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors Phase 1
Terminated NCT01234532 - Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery Phase 2
Completed NCT00416715 - Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer Phase 2
Completed NCT00119262 - Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer Phase 2