Dr. Breelyn Wilky is an oncologist specializing in sarcomas at Sylvester Comprehensive Cancer Center, part of UHealth, the University of Miami Health System. To make an appointment, call 305-243-1000. For more about Phase I clinical trials at Sylvester, Click Here for the visit the University of Miami’s health news blog
After three years of treatment failed to slow the growth of her cancer, Isabel Rodriguez began planning for the worst. “I went to the cemetery to plan my funeral,” she says. “I thought I was going to die.”
Isabel’s cancer, an aggressive angiosarcoma that grew rapidly beneath the surface of her skin, confounded her doctors as its perimeters consistently extended beyond the treated area. But just as she was losing all hope, a new Phase I clinical trial opened at Sylvester Comprehensive Cancer Center. Isabel’s oncologist Dr. Breelyn Wilky thought Isabel might be a good candidate.
“When I first met Isabel, I gave her standard chemotherapy treatments. We tried 10 different combinations. We tried surgery and radiation. By the time the Phase I trial came to be, she was out of options,” says Dr. Wilky.
Isabel became the first patient enrolled in the study under Dr. Wilky’s supervision. Historically, Phase I trials were the first step in testing a new drug in humans for safety and dosage. These trials often had little direct benefit for the patients enrolled. But the process has evolved, and today new developments in precision medicine have made it easier for doctors to match patients with treatments that might have an immediate benefit. “We’re trying to get new drugs to patients sooner based on the biology driving an individual patient’s cancer,” says Dr. Wilky.
In June, Sylvester opened a new clinic as a home base for patients participating in these Phase I clinical trials. Dr. Wilky says Sylvester’s new clinic space will help streamline the clinical trial process, which requires patients to participate in repeated labs, doctor’s visits, and other types of testing.
Isabel’s clinical trial was testing an experimental immunotherapy that engages a patient’s own immune system to recognize and kill cancer. Within 12 days of beginning the trial, the cancerous growth that had taken over most of Isabel’s face began to shrink.
“Her tumor on her face just exploded,” says Dr. Wilky. “It was obvious her immune system was recognizing the cancer as bad and going to work to try to get rid of it, which was incredibly exciting.”
“I kept saying, ‘Oh my god, it’s a miracle,’” says Isabel.
Phase I clinical trials still carry many risks and patients who are responding to traditional modes of treatment like chemotherapy might not be good candidates. But for those who have failed other therapies, the results can be remarkable. “Immune therapy is really a case that highlights where we can start Phase I clinical trials earlier, says Dr. Wilky. “Although the immune drugs are in Phase I, the chance of benefit from immune therapies is quite striking.”
Today, more than a year after completing the trial, Isabel’s cancer is completely undetectable by scan or biopsy. “Now my life is normal,” says Isabel. “The past is the past. I get to be me again.”
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