Early phase clinical trials provide cutting-edge treatment options to cancer patients

Phase I trials, the earliest stage of clinical studies, have historically been used to evaluate safe dosages of new treatment, such as chemotherapy or radiation. Later phases of clinical trials would evaluate how effective those approaches are in treating cancer.

While chemotherapy has historically been the main type of drug used to treat cancer, most newer treatments being developed are much more precise. These new approaches include developing treatments that can empower a patient’s immune system to fight cancer, as well as treatments that target a specific feature of cancer for a precision attack.

“Two or three decades ago, we were not expecting to see much (treatment) activity in phase I trials, but this has changed in the last decade,” said Dr. Nataliya Uboha, a gastrointestinal medical oncologist who leads the UW Health | Carbone Cancer Center Early Phase Oncology Therapeutics team.

“We have actually seen approvals by the FDA based on the results of phase I studies. We actually see people who are treated on phase I studies for several years, which was unheard of in the past (compared to history), and this means that the new therapies are working for them.”

Carbone Cancer Center’s Early Phase Oncology Therapeutics team oversees this emerging treatment research with a diverse team approach. While other research teams at Carbone are focused on one type of cancer, Early Phase Oncology Therapeutics’ work spans all cancers and relies on close collaboration among researchers from a wide range of specialty fields.

Within this team, Dr. Vincent Ma, a melanoma/skin cancer medical oncologist, provides expertise in immunotherapy. Dr. Zhubin Gahvari, a hematologist, is experienced in immune cell therapies and stem cell transplant care. Dr. Jeremy Kratz, a gastrointestinal medical oncologist, specializes in research on genetic and molecular features of cancer to develop targeted treatment approaches.

A few examples of ongoing research are:

• Several clinical trials testing targeted treatments for cancers with a mutated KRAS gene, which is present in about 90 percent of pancreatic cancer patients. This mutation is also common for colorectal and lung cancers.

• A theranostics trial that uses a radioisotope that can both map tumor locations in the body and be used to deliver a precision radiation treatment directly to those tumors. This trial targets the biomarker GD2, commonly found in melanoma, sarcoma and small cell lung cancer.

• Cellular therapies that modify white blood cells to help a patient’s own immune system recognize and attack cancer cells. This type of therapy has so far only been beneficial in blood and lymphatic cancers, and Carbone has two clinical trials ongoing to help expand this approach in “solid” tumors originating in organ systems.

Uboha and Ma credited the infrastructure at Carbone, including a clinical research unit to monitor patients with high needs during trials, as well as the dedicated and talented advanced practice providers, nurses, and other clinical trial staff who are instrumental to conducting these labor-intensive studies.

“Really all members of our cancer center are involved in many ways,” Uboha said. “They are dedicated to making sure that we can have these treatments available to our patients.”

Ma notes that Carbone’s ability to host such a variety of early phase clinical trials with highly-specialized components has made the cancer center a destination for patients seeking new and emerging treatment options.

“The research staff is just exceptional here, and we’ve been primed to open very complex studies, like immunotherapy-based studies, cellular therapy-based studies, and theranostic studies … many of which aren’t available elsewhere in the Midwest or in the U.S.,” Ma said. “We have numerous patients coming far and wide for these trials. This is why Wisconsin is one of the best cancer centers in the U.S. with dedicated phase I research.”