Abstract OT3-01-06: A phase I/IIa study of the whole-cell vaccine BriaVax™ in metastatic or locally recurrent breast cancer patients (NCT00095862)
Authors: Wiseman CL , Lacher M 
Published: March 2017

Abstract
BACKGROUND: BriaVax™ (formerly SV-BR-GM-1) is a breast cancer cell line transfected to release GM-CSF. Under FDA BB-IND 10312, the vaccine was tested in 3 metastatic breast, 1 metastatic ovarian cancer patients refractory to previous therapy. Patients received 20 million viable cells ID at 4 sites 48-72 hours after low-dose cyclophosphamide, 300 mg/m2 . Mean cell count was 22.8 x10^6 (18.8-27.6). Mean viability was 90.6%, (84-94%). Interferon-alpha (10,000 u) was injected into each inoculation site after 48 and 96 hrs. The protocol permitted 3 inoculations at 2 week intervals, then, if not showing clearly progressive disease, 3 more inoculations monthly. All patients were stable after 3 injections (2 months). However, Pt A002 enjoyed complete tumor regression of a progressing lung metastasis and near-complete response of multiple breast lesions (see below). Nonetheless, she relapsed widely 3 months after finishing the sixth and final injection per protocol. After obtaining FDA permission inoculations resumed. All metastases, including CNS, again showed prompt but subtotal regression after 3 immunizations (see Wiseman C and Kharazi A; The Breast Journal 2006). Toxicity was minimal and the overall survival of the 4 patients was 35 months.
TRIAL DESIGN: 9 patients will be accrued, toxicity (and also response) will be reviewed; unless there are prohibitive serious adverse events, 15 more patients will then be accrued.
ELIGIBILITY: Inclusion Criteria: Patients must 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 if they meet other conditions. Patients must be 18 years of age or older, have expected survival of at least 4 months, adequate performance status (ECOG 0-2). Patients may be maintained on hormonal therapy provided there is clear evidence of tumor progression and have provided written informed consent.
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). History of clinical hypersensitivity to GM-CSF, interferon, yeast, beef, or to any components used in the preparation of the experimental vaccine. Additional criteria to be provided on request.
SPECIFIC AIMS: To evaluate the number, frequency, duration, and relation of toxicity events to BriaVax™ (formerly designated as SV-BR-1-GM), as defined by CTCAE and additional tests; to evaluate tumor response and durability; to assess immune responses to vaccine; to archive blood and urine for future analysis; to measure quality of life with the SF-36 questionnaire.
For further information, call the BriaCell Corporate Office (US) at 888-485-6340
Acknowledgments: Dr. Gerhard Bauer, Dr. Saeid Babaei, the St. Vincent Medical Center, and Dr. George Peoples for advice and guidance.
Citation Format: Wiseman CL, Lacher M. A phase I/IIa study of the whole-cell vaccine BriaVax™ in metastatic or locally recurrent breast cancer patients (NCT00095862) [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-01-06.