|Phase I-II Study of HER2 Vaccination with poly(I) • poly (C12U)(Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients|
|This will be a randomized two-stage study. Patients will be enrolled concurrently during each stage.|
|Stephanie Parker | 866.932.8588 | E-Mail|
Number of Patients: This study will accrue a total of 98 patients (50 patients in Stage I, and 48 in Stage II)
- 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.
- 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)
- 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
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.