Office of Cancer Communications

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National Institutes of Health

EMBARGOED FOR RELEASE
March 24, 1999

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NCI Names Two Sites for Early Endostatin Trials

The National Cancer Institute has named two sites for its initial clinical trials of the anti-angiogenesis drug endostatin. They will be conducted at the University of Wisconsin, Madison, Wis., and the University of Texas M. D. Anderson Cancer Center in Houston.

Both sites will conduct an initial -- or phase I -- trial of approximately 15 to 25 patients each. The studies are expected to begin either in late summer or early fall of this year. They will involve people with advanced solid tumors that include, but which are not limited to, lung cancer lymphoma, breast cancer, colon cancer, and prostate cancer.

Phase I trials, the first step in human testing of possible new cancer drugs, typically involve a small number of patients. The principal objective is to define an appropriate dose and schedule of an agent in people before proceeding to more extensive clinical trials.

Endostatin gained widespread attention last year after press reports touted its ability, in combination with the anti-angiogenesis compound angiostatin, to eradicate a specific tumor in mice. The upcoming studies will be designed to evaluate the safety of endostatin specifically, and thus will not involve angiostatin. No angiostatin is available for human studies at this time.

Initial drafts of the protocols for these clinical trials will not be finalized for several weeks. For more information regarding how to participate in these studies, please contact:

• University of Wisconsin Cancer Connect Line
  1-800-622-8922 or (608) 262-5223.
  
  
• M. D. Anderson Information Line
  1-800-392-1611 - Select Option 3.