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Breast cancer treatment looks promising in phase 2 clinical trials

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A breast cancer treatment based on MIT radar research continues to move through clinical trials, with further promising results reported April 27 at the third annual American Society of Breast Surgeons meeting in Boston and in the May issue of the Annals of Surgical Oncology.

In the treatment, microwave radiation is focused externally on the breast, heating and killing tumor cells within. On April 27 Dr. Robert A. Gardner presented results for the first stage in a phase II clinical trial of the treatment. In this stage the thermal dose was increased gradually for 15 patients with early-stage breast cancer to determine which dose kills the most in cancer cells. The remaining patients in the phase II trial will now be treated at this dose.

"A majority of the patients being treated in this dose-escalation study are having their cancerous tumors significantly damaged by microwave heat therapy prior to lumpectomy," said Gardner, a breast surgeon at Columbia Hospital's Center for Breast Care in West Palm Beach, Fla., one of five hospitals currently approved to participate in the trials.

The phase II trial should be completed by the end of September. Twenty patients have been treated to date. The remaining 23 women will be treated at Columbia Hospital, the University of Oklahoma (OU), Harbor-UCLA Medical Center, Martin Luther University in Halle, Germany and at Comprehensive Breast Center in Coral Springs, Fla.

The goal of the phase II study is to demonstrate the potential benefits of destroying the cancer prior to breast conservation therapy (lumpectomy and radiation therapy). If this 30- to 40-minute heat treatment procedure can sufficiently damage breast tumors, the need for surgery or radiation therapy potentially can be reduced or eliminated.

The technology itself was invented by Dr. Alan J. Fenn, a senior staff member in the Sensor Systems Division at MIT Lincoln Laboratory. Fenn realized that the same focused microwave technology he'd used for missile detection could, in theory, be used to treat cancer cells.

The resulting treatment, he said, "uses externally focused microwave energy to target and destroy cancer cells in the primary cancer and in the margins." Celsion Corporation of Columbia, Md. exclusively licenses the technology from MIT. The company has developed the clinical thermotherapy system and is funding the clinical studies.

Results of a prior phase I study in 10 women with breast cancer showed significant tumor cell kill with focused microwave thermotherapy prior to surgery. That study, by Gardner and other phase I investigators, is being published in the May issue of the Annals of Surgical Oncology.

Principal investigators for the phase II clinical trials are Gardner at Columbia Hospital; William C. Dooley at OU; Hernan I. Vargas of Harbor-UCLA; Sylvia H. Heywang-Kobrunner at Martin Luther University; and Mary Beth Tomaselli at Comprehensive Breast Center. The Department of the Air Force funded the original MIT Lincoln Laboratory research by Fenn.

A version of this article appeared in MIT Tech Talk on May 8, 2002.

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