An MIT researcher's work on radar technology to detect missiles will be used in clinical trials for the treatment of breast cancer. A Phase I clinical trial was completed in July 2000 with some success so the FDA has approved going forward with the next phase. Alan J. Fenn, senior staff member in the Air Defense Technology Division at MIT's Lincoln Laboratory, told cancerpage.com that hospitals will accept women in the trial beginning in about February, 2001. The researchers reported that, in the first phase, after a single, limited-dose of heat treatment alone, "advanced breast tumors typically had been reduced in size or destroyed by about 50 percent in 8 out of the 10 patients," Dr. Fenn said. In the Phase II trials, more than 100 women will receive microwave thermotherapy to heat breast cancer cells to about 115 degrees Fahrenheit to kill them. Treatment May Cost $6,000 Per Patient. Celsion Corporation of Columbia, Maryland, which exclusively licenses the technology from MIT, “does not plan on selling the system, they will get reimbursed for each treatment, so there’s essentially no cost to any of the hospitals,“ according to Fenn. If thermotherapy becomes commercially available, the cost per patient “will probably be $4, 5, or 6,000; it’s not going to be $20,000 and it’s not going to be a few hundred,” Fenn estimated. It is well established that heat kills cancer cells, but no one knew how to heat-treat cancer deep within the body without burning the skin," Dr. Fenn explained. The focused microwave radiation in the new technique avoids heating the skin, and "heats – and kills – cells containing high amounts of water deep in the breast," he said. Breast cancer cells have a water content of up to 80 percent, while healthy breast tissue contains only about 20 to 60 percent water. "Our goal is to destroy all visible and microscopic cancer cells and pre- cancerous cells in the breast," Dr. Fenn said. If this focused microwave thermotherapy can destroy these cells, breast surgery could be reduced or eliminated, he hopes. There is the potential to reduce or eliminate conventional radiation to the breast as well. Dr. Fenn noted, however, that if the cancer has spread to other parts of the body, the patient would still need chemotherapy and conventional radiation. While only ten patients were treated in an FDA-approved Phase I safety study, eight of ten benefited. In the first phase to evaluate basic safety, each patient received a single 20- to 40-minute microwave treatment during which time their breast tumors were heated to about 115 degrees Fahrenheit. The Phase I study was conducted by Dr. Robert Gardner, MD at Columbia Hospital in West Palm Beach, FL and by Dr. Hernan Vargas, MD at Harbor-UCLA Medical Center in Torrance, CA, who are also operating the next phase. The results of the study have been accepted for presentation at the Society of Surgical Oncology Annual Cancer Symposium in March 2001 in Washington, DC. "After seeing the results of the Phase I study, I look forward to beginning the Phase II studies with the ultimate objective of providing breast conserving options to my patients," Dr. Gardner said in a press release. Non-Invasive Procedure: The procedure used two needle probes to sense and measure temperatures during treatment, in which the patient lies prone on a treatment table similar to that used in stereotactic breast needle biopsies. The needles do not transmit the heat however and there is no other invasive aspect. From a patient’s perspective, the heat is emitted from boxes placed against the breast. Side effects from thermotherapy were minimal. The only significant effect noted was a slight fever a few days following treatment, according to MIT’s press release. Two Phase II clinical trials are planned to be conducted at Columbia Hospital (Florida), UCLA Medical Center (California), Massachusetts General Hospital, Hammersmith Hospital (London) and two other hospitals. Advanced and early-stage breast cancer patients are being recruited. The purpose of the Phase II clinical trials is to demonstrate the effectiveness of the treatment. "About ten years ago we were working on radar anti-jamming technology to detect missiles from space-borne satellites," Dr. Fenn explained. "As the Cold War was ending and we were asked to look for alternative applications, I discovered that this same focused microwave technology for missile detection could, in theory be used to treat cancer cells." Patients with advanced breast cancer are sometimes treated with preoperative chemotherapy to reduce the tumor size, with the result that about 30 percent of the patients can avoid a mastectomy through breast conservation therapy (lumpectomy plus radiation) for an improved cosmetic result. However, viable tumor cells remain in the breast in about 75 percent of chemotherapy patients. "With focused microwave thermotherapy, we want to demonstrate a significantly higher rate of conversion from mastectomy to breast conservation therapy as well as a more complete destruction of the cancer cells in the breast," Dr. Fenn said. One part of the Phase II trial involves approximately 90 patients with advanced breast cancer who desire breast conservation therapy and currently are candidates for mastectomy. They will receive preoperative chemotherapy and three heat treatments, in an attempt to reduce the breast tumor size prior to surgery. The control will be patients receiving only preoperative chemotherapy. In a second part of the Phase II trial, approximately 40 patients with early-stage breast cancer will receive one or two heat-alone treatments to attempt to completely destroy the breast tumor prior to breast conservation therapy. "This study is intended to demonstrate the potential use of thermotherapy to reduce breast surgery," Dr. Fenn said. The original MIT Lincoln Laboratory research was funded by the Department of the Air Force. Dr. Fenn has received several United States and foreign patents assigned to MIT on the technology. To Enroll in Thermotherapy Clinical Trials: Contact: Dr. Robert Gardner, MD at Columbia Hospital in West Palm Beach, FL at 561-881-9200; or Dr. Hernan Vargas, MD at Harbor-UCLA Medical Center in Torrance, CA, 310-222-6715. From Cancerpage.com, Chris Thomas Ann's NOTE: Almost 5 years ago I met with a sales manager from Celsion Corporation, the company that has created this equipment. He told me about their Phase I trials which were then in the planning stage. It has now reached Phase II. I have placed a call(1/18/01) to Dr. Gardner's office in Florida to ask for the trial criteria. Sorry, reference lost Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.