Clinical 133

Title
Phase I-II Study of HER2 Vaccination with poly(I) • poly (C12U)(Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients
Study Design
This will be a randomized two-stage study. Patients will be enrolled concurrently during each stage.

Stage I (10 patients/group, 50 patients total):

  • Arm 1: HER2 peptide vaccine + 4 mcg Ampligen®
  • Arm 2: HER2 peptide vaccine + 20 mcg Ampligen®
  • Arm 3: HER2 peptide vaccine + 79 mcg Ampligen®
  • Arm 4: HER2 peptide vaccine + 495 mcg Ampligen®
  • Arm 5: HER2 peptide vaccine + 2000 mcg Ampligen®

Stage II ((24 patients/group, 48 patients total)

  • Arm 1: HER2 peptide vaccine + 100 mcg GM-CSF (control GMCSF arm)
  • Arm 2: HER2 peptide vaccine + 100 mcg GM-CSF + Ampligen® MBD
Study Contact
Stephanie Parker | 866.932.8588 | E-Mail
 
Patient Population
  1. Patients with optimally treated Stage II, III, or IV HER2+ breast cancer
  2. HER2+ breast cancer: IHC staining (1+, 2+, 3+) or HER2 gene amplification by FISH
  3. Must have completed definitive standard treatment and be in complete remission
  4. Stage IV breast cancer patients must have “No evidence of disease” with the exception of stable bone only disease, which is allowed
  5. Patients cannot be receiving trastuzumab during vaccine therapy
  6. Patients cannot be receiving any concurrent immunomodulators (such as systemic steroids) during vaccine therapy
  7. Patients cannot be simultaneously enrolled in any other treatment study
  8. Patients cannot have received a previous HER2 breast cancer vaccine
  9. Bisphosphonates and endocrine therapy are allowed

Number of Patients: This study will accrue a total of 98 patients (50 patients in Stage I, and 48 in Stage II)  

 

Patients Visits

  • Vaccines: 3 vaccines spaced one month apart
  • Follow-Up Visit: 1 Month after last vaccine
  • Follow-Up Blood Draw: 12 months after last vaccine; this follow-up blood draw can be done at primary physician’s office.

  Objectives

  1. To determine the Ampligen® “maximum biologic dose” (MBD) defined as the dose that results in the highest incidence and magnitude of HER2 immune response and the lowest incidence of toxicity when given with a HER2 vaccine. (Stage I of study)
  1. To determine if the Ampligen® MBD (defined in Stage I) when combined with GM-CSF as an adjuvant strategy with a HER2 vaccine increases the incidence and magnitude of HER2 immune response compared to the standard GM-CSF adjuvant strategy. (Stage II of study)

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

 

Related Publications

Concurrent trastuzumab and HER2/neu-specific vaccination in patients with metastatic breast cancer.
Disis ML, Wallace DR, Gooley TA, Dang Y, Slota M, Lu H, Coveler AL, Childs JS, Higgins DM, Fintak PA, dela Rosa C, Tietje K, Link J, Waisman J, Salazar LG.J Clin Oncol. 2009 Oct 1;27(28):4685-92. Epub 2009 Aug 31.

 

Scientific Description

ClinicalTrials.gov Identifier:NCT01355393

Clinical Trials Contact

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

Doreen Higgins
866-932-8588
Email