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SCCA Breast Cancer Clinical Trials

Ampligen w/Vaccine Therapy for Stage II-IV HER2-Positive Breast Cancer (7425)
Phase I-II Study of HER2 Vaccination with poly(I) poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients
Status Conditions Phase Study ID
Closed Breast Cancer Phase I/II 7425/133
NCT01355393
Summary

This randomized phase I/II trial studies the side effects and best dose of Ampligen when given together with vaccine therapy and sargramostim (GM-CSF) to see how well it works in treating patients with stage II-IV human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Vaccines made from synthetic HER2/neu peptides may help the body build an effective immune response to kill tumor cells.


Investigator
Lupe Salazar, MD
Location    
University of Washington - Tumor Vaccine Group 206-543-6620, TVGTrial@uw.edu  
Eligibility Criteria (must meet the following to participate in this study)
  • Patients with stage II, or III HER2+ breast cancer who have completed definitive standard treatment and are in complete remission - or -
  • Patients with stage IV HER2+ breast cancer treated to:
    • No evidence of disease, or
    • Stable bone only disease after definitive therapy
  • Patients must have demonstrated HER2 positive disease, by one of the following methods:
    • Immunohistochemical (IHC) staining of 1+, 2+ or 3+ for the HER2 protein, or
    • Amplification of the HER2 gene on fluorescence in situ hybridization (FISH)
  • Patients must be at least 14 days post cytotoxic chemotherapy prior to enrollment
  • Patients must be at least 14 days post systemic steroids prior to enrollment
  • Patients on bisphosphonates or continued hormone therapy are eligible
  • Men and women of reproductive ability must agree to contraceptive use during the entire study period
  • Patients must have Zubrod Performance Status Score of =< 2
  • 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
  • White blood cell count (WBC) >= 3000mm3
  • Hemoglobin (Hgb) >= 10 mg/dl
  • Serum creatinine =< 2.0 mg/dl or creatinine clearance > 60 ml/min
  • Total bilirubin =< 1.5 mg/dl
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times the upper limit of normal
  • Patients on trastuzumab (herceptin) monotherapy must have adequate cardiac function as demonstrated by normal ejection fractions (EF) on multi gated acquisition scan (MUGA) scan or echocardiogram performed within the last 3 months of eligibility sign off
Exclusions (conditions that would prevent participation in this study)
  • Patients with any of the following cardiac conditions: restrictive cardiomyopathy; unstable angina within 6 months prior to enrollment; New York Heart Association functional class III-IV heart failure; symptomatic pericardial effusion
  • Patients with any contraindication to receiving rhuGM-CSF based products
  • Patients with any clinically significant autoimmune disease requiring active treatment
  • Patients receiving any concurrent immunomodulators
  • Patients who are pregnant or breast-feeding
  • Patients who are simultaneously enrolled in any other treatment study
  • Patients who have received a previous HER2 breast cancer vaccine
Last Updated
September 10, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.