This week, the OHSU Knight Cancer Institute opened a new, 13,000-square-foot space devoted to serving patients taking part in early-phase clinical trials. The unit completes the build-out of the cancer clinic at OHSU’s Center for Health and Healing Building 2 in Portland’s South Waterfront District. Shivaani Kummar, M.D., FACP, is head of the Division of Hematology and Medical Oncology in the OHSU School of Medicine and co-director of the Knight Cancer Institute’s Center for Experimental Therapeutics. She talked with Cancer Translated about the impact of early phase clinical trials and how the new unit will give more people access to experimental cancer treatments in Portland.
Cancer Translated: Why are early phase clinical trials important for advancing the care of people with cancer?
Image: Shivaani Kummar, M.D., FACP, talks with OHSU Knight Cancer Institute Director Brian Druker, M.D., at the opening of OHSU’s early-phase clinical trial unit. (OHSU/Joe Rojas-Burke)
Shivaani Kummar: Early phase trials are conducted to test new treatments for cancer, while ensuring the highest standards of patient safety. When we’re developing new treatments for cancer, we are often trying to identify what makes the cancer different from normal cells or why currently used drugs are not working as well as we would like them to. And then we try to find what we call targets within or around cancer cells and develop drugs that can precisely hit those targets. These ‘new drugs’ go through very rigorous testing in the laboratory and only if they meet certain criteria as promising anticancer agents, we bring them forward into the first phase of human clinical trials.
CT: There was a time when phase 1 clinical trials were mostly about testing for toxicity and figuring out whether patients could tolerate an experimental agent, and very few subjects would show a response to the treatment. It’s amazing how much the situation has changed, isn’t it, with response rates of 70% or 80% seen now in some phase 1 trials.
SK: I used to tell patients that what we’re trying to figure out in a phase 1 trial is how much to give of a drug and how to give it. It used to be just safety and tolerability. Now we really are trying to figure out whether an experimental drug works in a particular patient population. The scope has expanded quite a bit because now we’re able to select patients for trials based on the particular biology of their cancer – what are the characteristics in a patient’s tumor that makes it more likely for a drug to help them. It used to be that anybody with an advanced solid tumor could participate in a solid tumor phase 1 study. Now we recruit subjects based on criteria such as the genetics of the tumor, the immune characteristics of the tumor, or protein markers that help us better select those more likely to respond.
CT: What else do you think people with cancer should know about early phase trials?
SK: Clinical trials in general present treatment options that may be appropriate for them and they should be asking their oncologists about available clinical trials. For early phase trials, patients need to know that the study drug could represent the next advance in cancer treatment. However, they need to be aware that phase 1 experimental treatments are only just beginning to be tested in humans. These studies are conducted ensuring the highest standards of patient safety and we do very closely monitor patients throughout the process. But people should discuss the pros and cons with their oncologists and the clinical trial investigators to decide if participating in a phase 1 trial makes sense.
‘Everything in this unit has been optimized to cater to the needs of patients on research protocols’
CT: How is the new clinical trials unit going to change things?
SK: First, it increases our capacity to enroll patients on early phase clinical trials. We’ve had very good care for clinical trial participants but we’ve had to accommodate them within our regular oncology treatment unit on the 11th floor. This new unit will provide dedicated space to treat patients on clinical trials, which gives us much more flexibility in scheduling and everything in this unit has been optimized to cater to the needs of patients on research protocols: the staffing, the equipment, the workflows, the scheduling, everything.
CT: What about the experience for people volunteering as subjects in clinical trials?
SK: One of the things we’re doing is centralizing everything. So, the patient’s initial blood work, the ECGs, their treatment, and the post treatment observation will be all done in this unit so they don’t have to be running around to different places. They don’t have to wait in line with the patients that are not on research studies to get their regular bloodwork.
Study participants will be surrounded by experts who are very familiar with the study protocols. All the nurses on this unit will have had education and training about the protocols. The research coordinators will have a very close relationship with these nurses, updating them on everything that is needed, what patient samples to collect, and we’ll have people to process those samples right away.
CT: This new unit is a fitting complement to the Center for Experimental Therapeutics, which you co-direct. Can you describe how the two programs will work together?
SK: Academic institutions put tremendous effort into understanding cancer biology, working with different models and experimenting with different agents aimed at cancer vulnerability targets they’ve identified. But this work seldom leads to new treatments in part because institutions don’t have the infrastructure in place to shepherd potential anti-cancer agents through the drug discovery and development pipeline. Our Center for Experimental Therapeutics is providing chemical biology expertise and pulling together the resources needed to take discoveries to the clinic.
There are obviously milestones to reach along the way and not every molecule lives up to its initial promise. But with the molecules that make it through the rigorous, pre-clinical testing that we do to measure anticancer activity and safety, we work with the clinical research management group at the Knight Cancer Institute to help us proceed with testing a new drug in patients. The Knight Cancer Institute’s phase 1 program is the transition point where those drugs go from preclinical to clinical testing. Now the studies developed by the phase 1 program can be efficiently conducted within the Early Phase Clinical Trials Unit on the 12th floor.
The Center for Experimental Therapeutics already has multiple promising projects undergoing testing in the preclinical space. We are already conducting early phase clinical trials within the Knight Cancer Institute. This new unit will expand our capability to conduct early phase trials of new ‘drugs’ developed within the Center for Experimental Therapeutics and by our external partners.
CT: Must feel pretty good.
SK: Oh yes. This unit is the result of tremendous efforts from a multidisciplinary team of professionals putting together a state-of-the-art facility to treat our cancer patients on early phase clinical trials.