[Joe]

It looks like they only need blood samples. Although Dr. Kute states that it would be nice for all of the candidates to live near Wake Forrest, i really don't think that is necessary.

Joe

I met you at the AACR meeting a few weeks ago and I have a question for your group. I am an associate professor in pathology at Wake Forest University and do breast cancer research. I am interesting in doing a clinical study on patients with HER-2 positive tumors. Listed below is our hypothesis, our aims and our goals. What we need are fresh blood samples to study antibody dependent (ie Herceptin) cell mediated cytotoxicity (ADCC). We want to correlate response to Herceptin with the patients ADCC activity. We would provide the container for the blood and the cost of shipment. This project would be done according to standard IRB practices. I have enclosed a recent paper that we published which provides our reason for doing these studeis. Please inform me if your group is interested in this study and how to proceed if you are interested.

Hypothesis: We propose that the immune system is the major pathway for Herceptin killing of tumor cells. We believe that all individuals have variability of their immune system to kill tumor cells through the ADDC pathway. Our hypothesis is that there is a direct correlation between ADCC activity and response to Herceptin treatment.

Aims

1. Measure ADCC activity of the mononuclear cells and compare this activity to the patient's clinical response to Herceptin treatment.
2. Determine why certain individuals have a better ADCC activity compared to other individuals (Data would suggest that ther is polymorphism in the FCgamma R III receptors on the immune cells)

Goals: Patients who have have HER-2 overexpression but have a low ADCC activity should be treated with tyrosine kinaase inhibitors that effect the activity of the HER-2 protein. While those whose tumors have a good ADCC activity should be treated with Herceptin. Finally, those patients who have a low ADCC activity should be treated with immune enhancing compounds while on the Herceptin treatment. Their immune system would be monitored during this treatment phases.

I could write more but I really am interested to know if your group could supply 30 patients for this pilot study. It would also be nice if they are in this area of North Carolina.

Thanks in advance,

Tim Kute
tkute@wfubmc.edu
336-413-6126