By Kim Polacek
Moffitt Cancer Center is preparing to launch a new, innovative clinical trial for brain-metastatic breast cancer patients, thanks to a new grant from the Department of Defense (DoD). The DoD awarded the cancer center a four-year, $8.3 million Breakthrough Award to fund a phase 2 clinical trial led by Brian Czerniecki, M.D., Ph.D., chair of Moffitt’s Breast Cancer Oncology Department.
The first-of-its-kind trial, which will begin accruing patients next year, will evaluate the efficacy of a three-part treatment strategy utilizing immunotherapy that includes:
- A dendritic cell vaccine developed by Czerniecki in collaboration with Pawel Kalinski, M.D., Ph.D. of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y.
- Chemokine modulation adjuvant therapy with rintatolimod (Ampligen) and interferon alfa-2B (Intron A)
- Immune checkpoint inhibition
“We know these three immunotherapies alone work well for a small number of patients, but our preclinical studies suggest that using them together in a three-pronged approach could increase tumor visibility to the immune system and in turn work to shrink the cancer,” said Czerniecki.
Roughly 10% to 15% of women with Stage IV breast cancer develop brain metastases, and there are very few treatment options for this group. The trial will begin first in patients with localized brain-metastatic breast cancer (BMBC) that is not widely spread, and then expand to include patients with disseminated, leptomeningeal BMBC.
For more information, please contact Taylor Lannon, clinical research coordinator, at Taylor.Lannon@Moffitt.org or 813-745-4395.