Clinical Trial Detail

PRIMARY OBJECTIVES:

- 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)

Ages Eligible for Study: Patients must be at least 18 years of age

- 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 cannot be receiving any concurrent immunomodulators (such as trastuzumab/herceptin) during vaccine therapy

- 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) >= 3000/mm^3

- 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 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

Other eligibility criteria may apply.

- 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 (such as Trastuzumab/herceptin) during vaccine therapy

- 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

Other exclusion criteria may apply.