Vaccine Therapy in Combination With Rintatolimod and/or Sargramostim in Treating Patients With Stage II-IV HER2-Positive Breast Cancer

OBJECTIVES: 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 immune response. 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 strategy. OUTLINE: This will be a phase I-II randomized two-stage HER2 vaccine study in breast cancer patients. 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 given i.d. 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.