Connecticut’s first center dedicated to conducting phase I clinical trials opened in Yale New Haven’s Smilow Cancer Hospital in mid-July.
Phase I trials test new drugs that have not been used before in humans, as well as existing drugs being used in a unique way or on different tumor types. According to David Vinas, the director of operations at Smilow, the phase I clinical-trial infusion center is an all-inclusive unit in which the patient care, research, pharmacy, lab and other units are located. He added that this collocation allows the doctors to provide well-coordinated and comprehensive care to those undergoing investigational therapies.
“The infusion center is critically important because it provides a dedicated unit with extraordinarily compassionate, competent and research-focused staff who care for those who are undergoing ‘first in man’ trials,” Vinas said.
According to Patricia LoRusso, associate director of innovative medicine at the Yale Cancer Center, the phase I center is focusing on testing new drug therapies for adult patients with advanced solid tumors. These therapies include “several targeted drugs, antibody drug conjugates and also immunotherapy drugs,” she said.
Although the Smilow Cancer Hospital had conducted phase I trials prior to the opening of the new center, there was no dedicated phase I space, according to Catherine Lyons, clinical program director at Smilow.
Lyons said that patients previously enrolled in phase I trials at Smilow were introduced into the general hospital population. Instead of treating these patients within the same space as those receiving conventional chemotherapy or infusion treatments, doctors at Smilow now have a space where they can concentrate their efforts and make sure they are following complicated phase I protocols to the letter, she added.
“[Phase I therapies] require an intensive level of specialized services to make sure that we are monitoring and collecting data according to very specific protocols,” Lyons said. “If we don’t follow them appropriately or specifically, then data can be lost or not able to be evaluated by the study sponsors.”
Lyons said that the center, currently comprised of 12 stations, allows Smilow to open an increasing number of trials and test the newest therapies for the benefit of patients who may have exhausted conventional treatments. Given that patients undergoing investigational therapies are typically at the center for long periods of time during each visit, there is also a nutrition center contained within the unit, LoRusso said.
Smilow Cancer Hospital has a history of cutting-edge research into investigational therapies. According to Lyons, Smilow did some of the earliest testing for the drug that is now standard for melanoma therapy. Lyons hopes that, just as Smilow patients benefitted from this drug long before it was commercially available, the new phase I center will continue to bring new therapies to patients at the earliest possible time.
Both Lyons and LoRusso pointed out that the center has plenty of potential for expansion. LoRusso said that Smilow is currently working to bring in newer trials and additional patients to aid the center’s internal expansion.
Robert Alpern, dean of the Yale School of Medicine, expressed enthusiasm for the new center. He stated that the unit is a well-organized space that will allow for the efficient expansion of Smilow’s clinical-trial program. Additionally, it will likely “be a place that many drug companies will come to in order to conduct their phase I trials,” he said.
The Smilow Cancer Hospital treats more cancer patients than any other hospital in Connecticut, according to its website.