A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors

Fecha de inicio: 1 de octubre de 2001

Inclusion Criteria: * Breast cancer: stage III or stage IV breast cancer with metastasis in remission and defined as NED (no evidence of disease); stable or healing bone disease by radiologic evaluation which may include, but is not limited to, bone scan, MRI, or PET scan documented within 90 days of enrollment to study and NED status for extraskeletal metastasis * Ovarian cancer: stage III or stage IV ovarian cancer in first complete remission with a normal AND stable CA-125; thus, two sequential normal CA-125 values will need to be documented; a minimum of 30 days between 2 sequential CA-125 values; the most recent will be within 2 weeks of enrollment into study * HER2 overexpression by immunohistochemistry (IHC) of 2+ or 3+ in their primary tumor or metastasis, and if overexpression is 2+ by IHC or in the absence of IHC, then patients must have documentation of HER2 gene amplification by FISH * Eligible subjects must have completed appropriate treatment for their primary disease and be off cytotoxic chemotherapy and corticosteroids for at least 1 month prior to enrollment; patients with stage III/IV breast cancer who have completed chemotherapy and are continued on trastuzumab monotherapy are eligible; hormonal and bisphosphanate therapies are allowed * Subjects must have a Performance Status Score (Zubrod/ECOG Scale) = 0 * All subjects must no longer be able to bear children * Hematocrit \>= 30 * Platelet count \>= 100,000 * WBC \>= 3,000/ul * Creatinine =\< 2.0 or creatinine clearance \>= 60 ml/minute * Serum bilirubin \< 1.5 mg/dl * SGOT \< 2 x ULN * Subjects must have recovered from major infections and/or surgical procedures and, in the opinion of the investigator, not have a significant active concurrent medical illness precluding protocol treatment or survival * Normal ANA, anti-dsDNA and C3 * Patients on trastuzumab monotherapy must have adequate cardiac function as demonstrated by normal ejection fraction (EF) of MUGA scan or echocardiogram Exclusion Criteria: * Subjects cannot be simultaneously enrolled on other treatment studies * Any contraindication to receiving GM-CSF based vaccine products * Prior known history of cardiac disease, specifically restrictive cardiomyopathy, unstable angina within the last 6 months prior to enrollment, New York Heart Association functional class III-IV heart or symptomatic pericardial effusion * Prior known history of pulmonary disease other than controlled asthma * Active autoimmune disease * Subjects cannot have active immunodeficiency disorder, e.g., HIV