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Dr. Peter Forsyth in the lab

Moffitt Cancer Center is actively recruiting patients with leptomeningeal disease from (LMD) Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC). This novel therapy is designed to treat breast cancer patients whose tumor has metastasized to the brain and the spinal fluid. This trial is a grant from the Department of Defense and is only available at a couple of cancer centers in the U.S.

Roughly 10% to 15% of women with stage 4 breast cancer develop brain metastases. Unfortunately, patients who develop the LMD disease only live about two to three months.

Therapeutic cell vaccines are a growing area of immunology research. These vaccines activate tumor-specific immune cell responses to help the immune system identify and attack cancer cells. A dendritic cell vaccine is a cross between a vaccine and a cell therapy. This is a first in human dose escalation of Dendritic Cell Vaccine (DCV) administered Intrathecally (IT) primed against HER2/HER3 in patients with Leptomeningeal Disease (LMD) from Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC).

This study was first developed by Dr. Brian Czerniecki in collaboration with Dr. Pawel Kalinski of Roswell Park Comprehensive Cancer Center in Buffalo, N.Y., to treat patients with localized brain-metastatic breast cancer (BMBC). It is now expanding to include patients with disseminated, leptomeningeal BMBC. The DCV study is used in combination with Chemokine modulation adjuvant therapy with rintatolimod (Ampligen) and interferon alfa-2B (Intron A), and an immune checkpoint inhibitor.

In the pretrial, researchers introduced the tumor cell to the spinal fluid of mice and gave them several doses of the dendritic vaccine. Their tumors were gone and they gained weight. Most of the animals were cured. Researchers are hoping to finally find a cure for LMD breast cancer patients with a dendritic cell vaccine.

If you'd like to refer a patient to Moffitt Cancer Center, complete our online form or contact a physician liaison for assistance.