Ann Thorac Surg 2000;70:411
© 2000 The Society of Thoracic Surgeons
Original articles: general thoracic
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DR JOSEPH B. ZWISCHENBERGER (Galveston, TX): This is really exciting work and it is obvious from your initial studies that the scaling problem, that is, the dosimetry, is the primary issue. You did not show any toxicity in those first initial patients. I was wondering if you have calculated the maximum dose that you estimate they will be able to tolerate. Because you have been speaking in terms of millions of cells and then you jumped quickly to billions of cells, I was trying to get an appreciation of scale.
DR HARRISON: We completed the dose escalation study, which goes up to 10 billion cells infused, and had no toxicity associated with that. We have not yet been able to accumulate enough data to know whether that dose is: (A) going to have any clinical impact, or (B) whether it can be exceeded geometrically. As I say, we have just about gotten to the end of our rope; 10 billion is a lot of cells. I have no expertise in that technology, but the people who produce these cells for us say that they have just about reached their capacity. So I can not answer your question except to say that we have not observed any toxicity that we have recognized.
As you know, this technique was employed in ovarian carcinoma with some very promising results; in 18 patients, there was only mild to moderate toxicity as measured by fever and abdominal discomfort but no severe toxicity. Four of 18 responded, three of whom appeared to have complete remission. That was Scott Freeman’s work. So I think it shows promise.
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