A Phase I/IIa Study of SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer Patients
This is a single arm, open label study of SV-BR-1-GM, a targeted immunotherapy for breast cancer. Eligible patients will have histological confirmation of breast cancer with recurrent and/or metastatic lesions. The treatment regimen includes a pre-treatment with low-dose cyclophosphamide 2-3 days before the inoculation; inoculation in 4 sites on the thighs and upper back; and post-treatment inoculation of Interferon-alpha-2b into the sites of inoculation \ 2 and \ 4 days after the inoculation. These is repeated every 2 weeks for one month (3 treatments), then monthly for up to one year. Standard tumor assessments are performed at baseline and then every 2-3 months.
• 1. Have histological confirmation of breast cancer with recurrent and/or metastatic lesions via investigational site.
⁃ Patients with new or progressive breast cancer metastatic to brain will be eligible provided:
∙ There is no need for steroids and patients have not had steroids at least 2 weeks
‣ No individual tumor size is \>50 mm3
‣ ECOG status \<3
‣ Tumor is not impinging on Middle Cerebral Artery/speech-motor strip
‣ If surgically debulked, must be healed from surgery and at least 3 weeks have elapsed since general anesthesia
‣ Patients consent to MRI studies at 3-4 week intervals until evidence of tumor regression on at least 2 imaging studies. In no case, will the interval between MRI studies be longer than 3 months. MRI study may be introduced at any time should the patients develop new or clearly worsening symptoms and/or introduction of steroids
• Have evidence of persistent, recurrent, or progressive disease for which there is no known or established treatment available with curative intent, after failing at least one course of community standard systemic treatment with chemotherapy (and endocrine therapy if appropriate)
• Be 18 years of age or older and female
• Have expected survival of at least 4 months
• Have adequate performance status (ECOG 0-2)
• Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression
• Have provided written informed consent.