SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer (NCT03066947) | Clinical Trial Compass
CompletedPhase 1/2
SV-BR-1-GM in Metastatic or Locally Recurrent Breast Cancer
United States24 participantsStarted 2017-05-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. Concurrent or recent chemotherapy (within 3 weeks), XRT within 3 weeks, may have had immunotherapy in the past (off within 3 weeks), or general anesthesia/major surgery (within 3 weeks). Patients must have recovered from all known or expected toxicities from previous treatment and passed a treatment-free "washout" period of 3 weeks before starting this program (8 weeks for persons receiving nitrosourea or mitomycin).
What they're measuring
1
Number of Patients With Treatment Emergent Adverse Events Occurring in Two or More Patients [Safety]
Timeframe: Through study completion, an average of 1 year
✕. History of clinical hypersensitivity to GM-CSF, Interferon-alpha-2b (Merck), yeast, beef, or to any components used in the preparation of the experimental vaccine.
✕. Bilirubin \>2.0; alkaline phosphatase \>5x upper limit of normal (ULN); ALT/AST \>2x ULN.
✕. Proteinuria \>1+ on urinalysis or \>1 gm/24hr.
✕. Left ventricular ejection fraction (LVEF as determined by cardiac echo or MUGA scan) below the normal limits of the institutions specific testing range. This assessment may be repeated once at the discretion of the Investigator with the approval of the Sponsor.
✕. New York Heart Association stage 3 or 4 cardiac disease.