The M Health Fairview Clinics and Surgery Center at the University of Minnesota Twin Cities campus.

Developmental Therapeutics Initiative improving Minnesotans' access to cutting-edge cancer treatments

As a comprehensive cancer center designated by the National Cancer Institute, our team of scientists, researchers, doctors, staff, and trainees at the Masonic Cancer Center, University of Minnesota (MCC), is nationally recognized for our innovative approaches to determining the causes of cancer as well as the best ways to prevent, detect, and treat it. MCC’s researchers and doctors employ these cutting-edge discoveries to improve quality of life for patients and survivors across all phases of the disease—from the earliest diagnoses to more advanced stages. 

One of the ways this treatment and care is often provided is through clinical trials. Clinical trials are studies of new medicines, procedures, and other types of treatments in people that doctors and researchers use to develop new methods of treating serious diseases, like cancer. Today’s clinical trials often become tomorrow’s new standard of care, boosting many patients' quality of life now, and helping ensure that future patients have continuously higher standards of care for years to come.

Driven by the overarching goal of meeting the needs of all patients, the Masonic Cancer Center, M Health Fairview, and the University of Minnesota Medical School’s Divisions of Hematology, Oncology, and Transplantation and Gynecologic Oncology partnered together in 2021 to develop the Developmental Therapeutics Initiative (DTI). This initiative is the main mechanism by which new, cutting-edge therapies are provided to patients across the University’s health system, and it’s one of only two robust programs in the entire state of Minnesota. The DTI has a clinic—the Developmental Therapeutics Clinic, or DTC—housed at the M Health Fairview Clinics and Surgery Center that takes referrals from anywhere in Minnesota and is currently open two days a week. 

What drove the decision to create the initiative and open the clinic? Why are Phase I clinical trials so important? And who are some of the people breaking new ground in cancer care for Minnesotans via the DTI? Let’s dive in.

Advancing today's understanding of cancer care

The Developmental Therapeutics Initiative is on a mission to create hope for patients, generate opportunities for faculty, and construct a forum for researchers to conceptualize cutting-edge bench-to-bedside research. On the clinical side, the program is geared toward patients who have advanced cancer and who have already received standard treatments that have not worked. Typically, these patients are also lacking new options—in other words, there are few to zero standard treatment options left available to them. That’s where Phase I, or early-phase, therapeutic cancer clinical trials come in. 

“We’ve identified that there is a large need for early-phase trials for a substantial portion of our patients,” says DTI Medical Director, Dr. Manish Patel, associate professor of medicine for the Division of Hematology, Oncology, and Transplantation at the U of M Medical School and a member of the Masonic Cancer Center. “The DTI provides structure via a team of people who all have expertise in running early-phase clinical trials and are able to match each patient with a novel, or new, therapy that we have available,” says Dr. Patel. 

Early-phase clinical trials are usually the first that involve people. These trials take promising results from lab research and test the new treatments in patients, evaluating whether they are safe for patients and finding out what dosage(s) work best without causing severe side effects. 

“Phase I trials are for drugs that have been tested in the lab and look very promising,” says Patel. “But taking it to the patients is very different. What we’ve observed in the lab may work for them, but we have to be very clear that we don’t know for sure that it will. For these trials, we don’t yet have enough data to give definitive answers—it’s from these trials that we get that data and are able to develop the next generation of standard therapeutics.” 

Dr. Patel adds, “Of course, we hope that the patients who are participating will directly benefit from these new therapeutics. But the patients themselves are also giving back to the greater good by contributing to our understanding of how these medications work for the benefit of future patients.”

At the clinic, Dr. Patel uses his extensive experience running early-phase trials to direct the DTC team. Patel leads team meetings, where staff members consisting of clinical research coordinators and registered nurses discuss what protocols, or trials, the clinic should open, as well as the science and feasibility of each to garner consensus about which trials they should run. Patel also helps to manage the patient care for patients enrolled in the clinic’s trials. 

Loana Ward, clinical director for the DTI, who manages the team of clinical research coordinators and registered nurses, notes, “The patient population we work with is such a sensitive group. Sometimes, a patient is deciding between a trial, which may prolong their life, or no treatment at all. The way our providers talk with each patient and walk through what their options are is really powerful. The weight of these options is very heavy.” 

Loana adds, “Everyone on our clinical team treats every protocol like it is the one, and really invests in each one. Our team knows just how crucial these trials are, both for today’s patients and for future patients, so we appreciate the innovation and life-saving potential of each protocol that comes our way.” 

Dedra Schendzielos, MHA, executive director for clinical research at MCC who oversees the Clinical Trials Office and the DTI team, adds, “Phase I research plays such an important role in the clinical and translational research process; testing the safety, dosing, and timing of new therapeutics is critical in contributing to ongoing and future research. The patients that participate in these trials are making important contributions to science while also doing everything they can to prolong their lives.”

Looking to the future

Currently, the team consists of seven faculty members and an advanced practice provider, or APP, and a team of research nurses and coordinators. Compare that to how the program started out, and it’s clear that the initiative has grown quite a bit in the past few years. 

Noting the collaborative nature of the program, Loana points out: “This team as a whole is unique, because it brings together so many different specialties—and that is different from a lot of other groups. Because our investigators come from a variety of specialties, we can treat many patients with different types of cancer.” 

The trials are considered multi-disease, or basket, trials, in which the team is learning which diseases a drug might work in. “For example, I might see a breast cancer patient even though I don’t have expertise in breast cancer because we’re trying to understand how to apply these drugs in different diseases and different types of cancer,” says Dr. Patel. “It’s very much an interdisciplinary team and process, and we always go back to the patient’s primary oncologist and discuss with them what specific trials we have available and where they might fit in that patient’s care. We work hard to keep the patient’s primary oncologist involved and engaged in this phase of the patient’s care as much as we possibly can.” 

“Looking forward, our main goal is to grow the program,” says Dr. Patel. 

One of the difficulties of Phase I research, Patel explains, is that the trials themselves often have limited slots to offer patients treatment. “You want to have at least 10-15 studies happening at the same time to ensure there are enough treatment slots for each patient that comes your way. Over the next five years, we want to have 30 active protocols at a given time, and we aim to accrue around 100 patients a year onto Phase I trials.” 

To accomplish those goals, the team will have to continue to expand its staff, adding critical capacity that supports the cancer center’s goal of improving its ability to translate innovative science into the clinical space. 

In Dr. Patel’s words, “As an institution, we are really world-class in basic science,” referring to the research that is conducted in labs. “Where we’ve often been more limited is in turning the science into clinical trials, which is the express purpose of this initiative.” 

He adds, “The reality of today is that much of our research will be supported by industry. But the hope is that a significant portion of our portfolio will be local science with U of M investigators, or lead researchers, developing the protocol and having it come from our scientific community at the University and at the Masonic Cancer Center.” 

The team notes that they’ve been in early discussions about creating a forum for basic scientists to vet their ideas, helping them find the right space to translate their research discoveries into clinical trials where they can help patients now and for generations to come. 

Patel, Ward, Schendzielos, and team are also excited about reverse translation, where insight gleaned from patient interactions is taken back to the laboratory. “It’s an iterative process,” says Dr. Patel. “We learn something from a Phase I trial, and then we take it back to the lab, answer questions, and bring it forward to a clinical trial again.”  

All of us here at MCC believe collaboration—between patients, clinicians, and researchers—is the best way to accelerate the discovery and development of breakthrough cancer treatments. As the DTI grows, widening the scope and deepening the impact of the cancer center’s clinical research in Minnesota and beyond, each new trial brings new hope in our pursuit of new cures for cancer.