Thursday, May 31, 2007

Trial starts soon...

Chris found out that all of her recent tests were pretty normal. This was a requirement to begin her clinical trial. She goes to Hopkins next week for a skin biopsy on Tuesday. This is part of the trial and they use it for monitoring progress. On Wednesday she goes for bloodwork. Not the normal workup though. She has to give a LOT of blood. Kind of like a Donor. This gets sent all over the place for various tests.

The actual trial starts on Monday June 11th with a chemotherapy treatment followed by the vaccine injection on Tuesday followed by many days in a row at the hospital for bloodwork and followups. It's very intensive the 1st week. I'll post more as soon as I have specifics.

Here is some information on the work being done by Chris's oncologist:
Research Summary

Dr. Emens develops and tests active vaccination strategies for breast cancer treatment that are optimally integrated with traditional anticancer therapies and newer biologically targeted therapies in additive or synergistic ways. She developed a genetically-modified, cell-based vaccine for breast cancer that secretes the immune-stimulating hormone granulocyte-macrophage colony-stimulating factor (GM-CSF), and is testing the vaccine in combination with low doses of Cyclophosphamide (CY) and Doxorubicin (DOX) in patients with Stage 4 breast cancer.

In a mouse model of spontaneous breast cancer where the vaccine does not work, adding CY and DOX cures about 30% of tumor-bearing mice. This chemotherapy effect is largely due to the ability of CY to turn off a special type of immune cell (regulatory T cell) that keeps immune responses shut down. Analysis of patient samples on this trial will yield insight into relevant immunoregulatory pathways in humans that will support the better design of future vaccine trials.

Dr. Emens has also investigated the addition of monoclonal antibodies that target either the tumor itself (HER-2/neu), or the tumor microenvironment (vascular endothelial growth factor receptor 2 (VEGFR2) to chemotherapy-modulated vaccination. Both add futher to the antitumor effect of the vaccine.

In particular, HER-2/neu-specific monoclonal antibodies augment antigen processing and presentation, resulted in higher numbers of CD8+ T cells after chemotherapy-modulated vaccination in the presence of the antibody. Based on these data, Dr. Emens is preparing to launch a clinical trial testing the HER-2/neu-specific monoclonal antibody in combination with CY-modulated vaccination in patients with HER-2/neu-overexpressing breast cancer.

The overall goal of Dr. Emens research is to elucidate mechanisms of immunoregulation in patients with breast cancer using the vaccine in combination with standard breast cancer drugs and novel therapeutics. These studies should identify novel drug targets to improve breast cancer therapy.

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