The challenges brought on by a cancer diagnosis, especially a rare type with few treatment options, can feel insurmountable. M Health Fairview oncologist Dr. Manish Patel recalls a patient diagnosed with thymic carcinoma, a rare cancer developed in the thymus—part of the body’s immune system—with no therapies approved by the Food and Drug Administration (FDA). But the cancer was still progressing, and it was time to act right away.
Fortunately, Dr. Patel is part of a group of motivated University of Minnesota researchers specializing in cutting-edge clinical trials to treat many types of cancer. Their work is based at the University of Minnesota’s Developmental Therapeutics Clinic (DTC), which debuted at M Health Fairview’s Clinic and Surgery Center this past February.
Across medical specialties, clinical trials provide the pathway for new medicines to move from the laboratory to the general population. Trials in phases I, II, III, and IV gradually ramp up the numbers of people involved and test drugs for safety, dosage, and efficacy along the way before they can be approved.
“The DTC tests novel therapies in patients with cancers who either have not responded to conventional treatments or otherwise don’t have great options for treating their cancer,” says Dr. Patel, who set up the clinic with his colleague Dr. Charles Ryan. “Particularly for patients with rare tumor types, phase I clinical trials are the only opportunity to receive cutting-edge treatments. Rapid accrual of these types of trials are critical to getting these drugs to more-advanced clinical trials and ultimately to [the Food and Drug Administration (FDA) for] approval for the wider community.”
Dr. Patel’s thymic carcinoma patient has had an amazing result while being treated as part of a phase I clinical trial combination of a live virus as therapy (VSV-IFN-NIS) and the immunotherapy drug Avelumab. According to Dr. Patel, the patient has been feeling basically normal, without evidence of disease on scans, for more than a year. Without the phase I trial, this therapy would not be available to patients with such a rare disease.
Although COVID-19 vaccines have moved through clinical trials at unprecedented speeds, this process often takes many years for new cancer medications, especially when only about 5% of cancer patients currently take part in clinical trials. As the first clinic of its kind in the Twin Cities—Mayo Clinic operates an Experimental Therapeutics Program in Rochester—the DTC hopes to help significantly raise the number of participants.
“Each trial is a little bit different,” says Dr. Patel. “Often with phase I trials, only three patients at a time can be treated. We evaluate the safety, and then we are allowed to treat more. Most of these trials are pretty fluid, and the openings can change very rapidly.”
The DTC clinic’s early-phase and clinical trials can target several different cancers, not just one specific type. Both cellular and immune treatments, mostly for solid tumors, originate from both U of M research and the pharmaceutical industry. In addition to the physicians involved, the University of Minnesota’s study coordinators, nurses, and regulatory specialists are part of a team dedicated to conducting these trials efficiently. Patients who attend this clinic receive dedicated time on a weekly basis.
“The key is to maintain both hope and realistic expectations,” Dr. Fujioka says. “Hope can have many definitions depending on the individual. The clinic potentially offers treatments that cannot be accessed elsewhere, which brings hope to many. Many patients are incredibly altruistic, and hope means the possibility of helping others in addition to possibly themselves, regardless of the outcome of participating in a clinical trial.”
Many of the patients treated at the DTC have exhausted traditional options, and cannot afford to wait for new therapies to reach the public. Over the past decade, Dr. Patel has been excited to see patients with previously incurable cancer develop long-term remissions with either immune therapy or targeted therapy. He is heavily involved in developing powerful natural killer (NK) cell therapies for solid tumors using cells grown using technology based upon science developed in the U of M’s labs.
Dr. Fujioka also remains positive about future treatment possibilities and cites the recent FDA approval of a drug, sotorasib, that blocks the proteins causing hundreds of thousands of lung cancer cases. “New knowledge and new treatments are always coming down the pipeline,” she says, “thanks to patients participating in clinical research and innumerable researchers dedicated to studying cancer in hopes of helping people live longer and better.”