Section 6
Clinical Trials with Anti-Angiogenic Agents

The breast cancer program at Indiana University has been very focused on angiogenesis and anti-angiogenic therapies for about five years — this has really spanned from basic bench laboratory research in animals and xenograph models to angiogenesis and combinations into clinical trials. We are a small program, and having a critical mass of researchers who are all focused on the same research question is important to being successful and getting cross-pollination of ideas.

It is surprising how truly little we know about the anti-angiogenic effects of drugs. My colleagues have come up with a very simplistic way of segregating anti-angiogenic drugs. One group has been the vasculostatins, which may not affect the existing tumors and vasculature but merely prevent the growth of new blood vessels. So, those are drugs where you would not expect to see traditional responses but more prolonged stable disease. These statins contrast to the vascular toxins, which actually are toxic or cytocidal to tumor vasculature, where you would expect to see traditional shrinkage of tumors.

And we actually segregated some of the drugs that were in clinical trials into what we thought would be vasculostatins and vasculotoxins about a year ago. And through the further clinical development of those drugs, we’ve now learned that with virtually every drug that we tried to put in one of those categories, we were dead wrong. So, with drugs that we thought would be purely vasculostatic — that the best they could give you was prolonged stable disease — we have patients who have complete responses that lasted for over a year. Whereas, drugs that in the laboratory looked like they should be very toxic to vasculature have yet to result in a clinical response in any of the clinical trials. So, we know a lot about these drugs,but what they do in people is very much a work in progress.

—Kathy M i l l e r, MD

- Review Select Publications

- Review Other Clinical Trials

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