A Phase I Trial Investigating the Safety and Immunogenicity of an Adenovirus Encoding Rat HER-2 Administered Intradermally to Patients With Metastatic or Locally Recurrent Breast Cancer
1. metastatic or locally recurrent breast cancer,
2. 18 years of age or older,
3. Her-2/neu positive (3+ by immunohistochemistry or FISH +),
4. One of the following
1. currently receiving hormonal therapy or are candidates for such or,
2. being considered for trastuzumab or,
3. their cancer has progressed on trastuzumab
1. Pregnant or lactating women.
2. Prior or concurrent malignancies except treated basal cell or squamous carcinoma of
the skin or in situ cancer of the cervix or any other cancer treated and presumed
cured more than five years prior to study entry.
3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or
biological cancer therapy. [Note: concurrent hormonal therapy (tamoxifen,aromatase
inhibitors, or megace) is permitted.].
4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy.
5. Hemoglobin < 80 g/L or granulocytes < 1.5 x 109 /L or lymphocytes < 1.0 x 109 /L or
platelets < 100 x 109 /L.
6. Baseline liver enzymes (AST or ALT) greater than 3 times upper limit of normal or
greater than 5 times upper limit of normal if liver metastases present and/or
bilirubin greater than 50 mmol.
7. CD4 cells < 0.5 x 109 /L
8. Patients with documented brain metastases.
9. Patients with any acute illness that would interfere with vaccination
10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids).
11. Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
12. Patients with a life expectancy of less than 6 months.
13. Geographic inaccessibility which would preclude follow-up. Patients registered on
the trial must be treated and followed at the Jewish General Hospital.
14. Failure to give written informed consent.
15. Baseline left ventricular ejection fraction (LVEF) < 55% by echocardiography or MUGA