Phase I-II Study of HER2 Vaccination With Poly(I) • Poly(C12U) (Ampligen®) as an Adjuvant in Optimally Treated Breast Cancer Patients
I. To choose the most promising (maximum biologic dose [MBD]) of five different doses (4,
20, 79, 495 and 2000 mcg) of Ampligen (rintatolimod) administered intradermally (i.d.) as an
adjuvant with HER2 vaccination, with respect to toxicity and incidence and magnitude of
II. To determine, using MBD of Ampligen (defined in first primary aim), whether Ampligen
when given with GM-CSF as a combined adjuvant strategy with HER2 vaccination increases both
the incidence and magnitude of HER2 Th1 immunity as compared to the standard GM-CSF adjuvant
OUTLINE: This will be a phase I-II randomized two-stage HER2 vaccine study in breast cancer
STUDY STAGE I: There are five groups of patients randomized to 1 of 5 arms with each arm
receiving the synthetic HER-2/neu peptide vaccine admixed with rintatolimod (different
doses) given i.d.
STUDY STAGE II: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive the synthetic HER-2/neu peptide vaccine admixed with rintatolimod
ARM II: 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF and the
other 24 patients will receive the HER-2/neu peptide vaccine admixed with GM-CSF in addition
to rintatolimod (dose set by Stage I group that had the most active response) given i.d.
In both study stages, treatment repeats every month for up to 3 months in the absence of
disease progression or unacceptable toxicity.
After completion of last vaccine, patients are followed up at 1 and 12 months.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of immune response among the different treatment arms in Stage I and II
Use standard interferon (IFN)-gamma enzyme-linked immunospot (ELISPOT) assay to evaluate CD4+ Th1 T cell responses to HER2 immunizing peptides.
Up to 12 months post-vaccination
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|