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Phase I/IIa trial of BriaVax in Metastatic Breast Cancer Patients

This study includes patients that have stage IV metastatic breast cancer. There will be approximately 24 people volunteering for this study from approximately 4 hospitals in the United States.

The goal of this trial is to evaluate the number, frequency, duration, and relation of toxicity events to BriaVax and to evaluate the tumor response in metastatic breast cancer. BriaVax (formerly called as SV-BR-1-GM) is an experimental, HER-2/neu positive, allogeneic, whole cell breast tumor cell line transfected with the GM-CSF gene to secrete GM-CSF in situ and consequently augment dendritic cell activity.

Stage IV metastatic breast cancer patients will be identified and screened for inclusion/exclusion criteria. Patients who meet the eligibility criteria will be counseled and consented for enrollment into the study.  Patients will then start initial inoculation cycles 1-3, every 2 weeks for 1 month, followed with monthly cycles for 6 months (cycles 4-8). Those patients that have a non-progressive response and wish to continue treatment will have optional monthly cycles for up to 12 months total duration (14 total cycles).

Safety data will be collected on local and systemic toxicities and graded. Tumor responses and immunologic reactions will be monitored. Quality of life will also be assessed via questionnaire, along with weight, performance status and pain level throughout the study.

Blood (50 mL) will be collected from all patients at each inoculation and at baseline for a total of 7 time points or a total of 350 mL of blood over 6 months. If the patient is eligible and opts for the additional treatments it would increase to 13 time points for blood draws for a total of 650 mL over 12 months. The blood will be tested for complete blood count, complete metabolic panel, T&B subsets, LDH, SGPT, GGTP, and serologic markers. Additional blood samples will be collected at the same time points for stored in tissue repository. A urinalysis will also be performed and storage in the repository for future analysis at each blood draw time point.  Radiographic imaging will also be obtained to follow tumor progression at baseline, at months 3 and 6, then optionally if eligible at months 9 and 12. Identifier: Upcoming