Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer

Exclusion Criteria

• •Known or suspected allergies to any component of the vaccine
• •Active infection requiring antibiotics are excluded.
• •The following medications or treatments within the 4 weeks (28 days) prior to consenting. These medication and treatments may not be re-started at any time throughout the study in order to remain eligible.
• •* Breast tumor resection surgery (reconstructive surgery permitted)
• •* Chemotherapy
• •* Radiation therapy
• •* Allergy desensitization injections
• •* Growth factors (e.g., Procrit®, Aranesp®, Neulasta®)
• •* Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)
• •* Any investigational medication
• •Tthe following medications or treatments within the 4 weeks (28 days) prior to consenting:
• •* Corticosteroids, administered parenterally, orally, or inhaled (Inhaled steroids, such as: Advair®, Flovent®, Azmacort.®)
• •* Topical corticosteroids are acceptable.
• •Previous vaccination with any of the synthetic peptides included in this protocol.
• •Active tuberculosis and not on active antitubercular agents
• •Pregnancy.
• •Female subjects must not be breastfeeding
• •A medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator
• •New York Heart Association classification as having Class III or IV heart disease
• •Stage IV subjects who have anticipated chemotherapy need within the 108 day treatment period for this trial.
• •Subjects that have experienced active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the 6 weeks (42 days) prior to consenting.
• •* The following will not be exclusionary:
• •* The presence of laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
• •* Clinical evidence of vitiligo
• •* Other forms of depigmenting illness
• •* Mild arthritis requiring NSAID medications