Sep. 20, 2001 CAMBRIDGE, Mass. -- A breast-cancer treatment based on MIT radar research is now in Phase II clinical trials, and preliminary results to be reported at a September 24 meeting look promising.
In the treatment, microwave radiation is focused externally on the breast, heating and killing tumor cells within. "After thermotherapy treatment, we are seeing significant breast cancer cell kill without damage to the skin," said Dr. Robert A. Gardner, MD, of the initial Phase II results. Gardner is a breast surgeon at Columbia Hospital’s Center for Breast Care in West Palm Beach, Florida, one of three hospitals currently participating in the trials.
At the 24th International Congress on Clinical Hyperthermia in Rome, Italy, September 24-29, Gardner and other clinical researchers involved in the study will present the results for thermotherapy of four women with early-stage breast cancer. The Phase II trial should be completed in 2002 with the treatment of 39 other women at Columbia Hospital, Martin Luther University in Halle, Germany, and Harbor-UCLA Medical Center in California.
A second Phase II trial for 90 patients with locally advanced breast cancer should begin this month at Columbia Hospital. Martin Luther University is also accepting patients. This trial, too, is expected to be completed in 2002.
Celsion Corporation (Columbia, Maryland) exclusively licenses the technology from MIT. The company has developed the clinical thermotherapy system and is funding the clinical studies.
The technology itself was invented by Dr. Alan J. Fenn, senior staff member in the Sensor Systems Division at MIT Lincoln Laboratory. It is based on space-borne radar technology Fenn originally developed to detect missiles and nullify enemy jamming.
"The adaptively focused microwave radiation used in the technique avoids heating the skin, and selectively heats -- and kills – cancer cells spread within a large region of the breast," Fenn said.
Due to both higher water and ion contents, breast cancer cells absorb about two to four times more microwave energy than healthy breast tissue, destroying the cancer.
If the thermotherapy technique can destroy breast cancer cells, breast surgery could be reduced or eliminated. There is also the potential to reduce or eliminate conventional x-ray radiation. Surgery, x-ray radiation, and chemotherapy have significant side effects and do not always eliminate all of the cancer cells.
The goal of the Phase II study treating women with early-stage breast cancer is to demonstrate the potential benefits of destroying the cancer prior to breast conservation therapy (lumpectomy and x-ray radiation).
The women with locally advanced breast cancer in the second Phase II study will receive both preoperative microwave thermotherapy and preoperative chemotherapy treatments. The goal is to more effectively destroy breast cancer cells and shrink the tumor to decrease the need for mastectomy. The randomized study will compare results from preoperative thermochemotherapy to preoperative chemotherapy alone. The first patient in this study is scheduled to be treated at Columbia Hospital this month by Gardner.
Principal investigators for the Phase II clinical trials are Gardner at Columbia Hospital; Sylvia H. Heywang-Köbrunner, MD, of Martin Luther University; and Hernan I. Vargas, MD, of Harbor-UCLA.
The Department of the Air Force funded the original MIT Lincoln Laboratory research by Fenn. An article by Fenn and colleagues about the adaptive microwave phased array radar technology was published in a recent issue of the MIT Lincoln Laboratory Journal.
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