A Phase I Cancer Vaccine Study for Patients With Metastatic Breast Cancer

The study is an open-label study to assess safety and immune responses to the universal
tumor antigen OFA/iLRP. All patients will be immunized with 1 x 107 viable OFA/iLRP-loaded
mature, autologous monocyte-derived dendritic cells (DCs). The DC vaccine will be
administered intradermally into the proximal medial upper extremity, contralateral to the
original site of breast cancer once every month for 3 months. Changes in the tumor will be
documented. The patient will remain in the study unless toxicity or adverse side effects
require discontinuation following RECIST and CTC guidelines, or if the patient withdraws for
any other reason.

Inclusion Criteria:

- Stage IV histologically proven breast cancer as defined by the AJCC Cancer Staging
Manual (6 th. Edition 2003).

- Patients must have completed one prior form of chemo and/or radiation therapy for
their disease and have failed to achieve remission.

- There must be no clinical or radiographic signs of active brain metastases (CT of
brain), or disease to the brain that is not considered controlled.

- At least 4 weeks must have elapsed since chemotherapy or biological therapy and 2
weeks must have elapsed since radiotherapy

- Female patients must be at least 18 years of age

- Must be ambulatory with a ECOG performance status of <2

- Must have common recall antigen DTH skin reaction >2 mm

- Must have lab values as following ANC > 1.5 x 109/L; platelets > 100 x 109/L, Hb> 9
g/dL, creatinine < 1.8 mg/dL or a creatinine clearance > 35 mL/min; total bilirubin <
2 the upper limit of normal, AST and ALT < 2.5 the upper limit of normal; albumin
>2.5 g/L

- If of child bearing potential, must practice a reliable method of contraception at
screening and must agree to continue this status until 6 months after receiving the
last study vaccine injection. An HCG (pregnancy) test will be done monthly until the
3 vaccinations are complete.

- Signed informed consent (see Appendix A, Clinical Protocol section 25.1) to be
obtained according to ICH GCP guidelines before the patient is subjected to any extra
diagnostic procedures performed for evaluation of eligibility for the trial.

Exclusion Criteria:

- History of other prior malignancy, with the exception of curatively treated basal
cell or squamous cell carcinoma of the skin or cervical cancer stage IB

- Active infection requiring continuous use of antibiotic therapy

- Significant cardiac or other medical illness that would limit activity or survival,
such as severe congestive heart failure, unstable angina, or serious cardiac
arrhythmia

- Autoimmune disease currently treated with steroids

- Adverse reactions to vaccines such as anaphylaxis or other serious reactions, e.g.
life-threatening reactions to medicine

- History of immunodeficiency or autoimmune disease such as rheumatoid
arthritis,systemic lupus erythematosus, scleroderma, polymyositis dermatomyositis,
juvenile onset, insulin dependent diabetes, or a vasculitic syndrome

- Pregnancy or lactation

- Any reason why, in the opinion of the investigator, the patient should not
participate

- Patients who have received cytotoxic anti-tumor therapy within 4 weeks prior to
vaccination

- Patients with active hepatitis (B, C) or HIV+ individuals

- Patients with more than four different lines of chemotherapy in the metastatic
setting (excluding adjuvant chemotherapy).