Clinical Trials

Speaker 1: Welcome to Bench To Bedside, a weekly series of live conversations about recent advances in cancer from the research bench to treatment at the patient's bedside. And now, your host and the director of the University of Kansas Cancer Center, Dr. Roy Jensen.

Dr. Roy Jensen: Every time you make a purchase in Johnson County, you may not know it, but you are supporting cancer research in a very unique tax-supported initiative known as JCERT. JCERT stands for Johnson County Education Research Triangle authority. Hi, I'm Dr. Roy Jensen, director of the University of Kansas Cancer Center. With me, is Mary Birch, chair of the KU Cancer Center's Funding Partners Board and Cancer Center Advocate, and also Dr. Tara Lin, Medical Director of the KU Cancer Center's Clinical Trials Office. 10 years ago, a special sales tax was passed in Johnson County providing KU Cancer Center the vital resources needed to offer more clinical trials to our patients. So, Mary, you played a huge role in building the community support necessary to pass this sales tax. Could you tell us more about the JCERT initiative, how it came about, who was behind it and just...

Mary Birch: Sure. Believe it or not, the JCERT initiative was born on a tennis court with then Senate President, Dick Bond, and myself, and when we took breaks, we talked about the kinds of things that needed to happen. KU Edwards had made an effort to maybe do something because they needed to grow and add degrees. And at the same time, Olathe gave a piece of property to K State and a big study had come out about the life sciences economy in Kansas City, and the question became what is Johnson County's piece of that? So as a result, the triangle was invented. We were able to put KU and K State in the same room for a while and worked on it. We needed legislation in Topeka and that was really Kenny Wilke, the head of the tax committee, Barbara Allen, the head of the tax committee in the Senate and Dick Bond and Audrey Langworthy who supported allowing our voters to decide. And then we needed County Commission permission. That's where you and some of the others came in to talk about putting it on the ballot because they had to put it on the ballot. And then Fred Logan shared the campaign. It's probably the first campaign I know of in 40 some years of working in the community where both Missouri and Kansas participated. Bill Hall chaired the fundraising effort and raised enough money for us to do the campaign. I was kind of behind the scenes at the time. I made two, three hundred presentations to the voters because this was unique because it had never been done before. But the beauty of Johnson County is that it's always been very hopeful and it always likes a big vision, and this was a big vision. So the funding of it was I called you one day and said, "What do you need?" and we talked about the clinical center and we put it on the ballot for 1/8 cent sales tax. All you needed about five, six million dollars and that was what it raised. Today it raises a little more, which is good. And the voters bought it and they really liked it and they've been supportive. So we have ten new degrees at Edwards. We have certifications and degrees and bachelor's degrees going on at K State, and we have treated a lot of our own people for cancer since the clinical trials research center.

Dr. Roy Jensen: So Dr. Lin, you're in charge of our clinical research center down there in Fairway. Could you tell us a little bit about the purpose of that facility?

Dr. Tara Lin: So the CRC, like we've said, is really a unique resource within our cancer center and we're so grateful for the community support that makes it happen. What we do at the CRC is what we call early phase clinical trial. So these are some times brand new drugs that are being given to the first time for humans. These may be drugs that are still in early development for diseases that they weren't originally designed for. And what's incredible is that we're able, through the CRC, to give our patients the access to these innovative cutting edge treatments right here at home. In addition to conducting early phase trials from outside sponsors, the CRC is able to run and develop clinical trials for what we call investigator initiated trials. So these are ideas from KU physicians, KU scientists taking our own ideas from the laboratory, bringing it to the clinic, and making the latest and greatest available to our patients here at home. Dr. Roy Jensen: Mm-hmm (affirmative). So how does the CRC support the KU Cancer Center's mission to really conquer all cancers?

Dr. Tara Lin: What we're doing at the CRC is these early phase clinical trials. And so since its inception in 2012 through now, we've treated over 500 patients on early phase and investigator initiated trials. At present, we have over 75 trials open across all disease types, so it's not just specific to any one disease. We have a lot of different trials that cover one disease type, but we also have many trials of new targeted agents where the drugs are targeting a specific mutation that might be applicable to someone with lung cancer and breast cancer and leukemia. And because of this unique facility, we're able to conduct all of those trials for all of those patients in the same place safely and completely.

Dr. Roy Jensen: If you're just joining us, we're here with Mary Burch and Dr. Tara Lin talking about the Johnson County Education Research Triangle or JCERT, which is a local sales tax that supports clinical trials. If you have any questions, post them in the comments below. Remember to share this link with people who may benefit from our discussion. Use the hashtag BenchToBedside. So, Dr. Lin, you gave us some examples of the types of clinical trials being conducted at the CRC. Could you tell us a little bit about how we leverage this facility to really provide cutting edge clinical research opportunities for our patients?

Dr. Tara Lin: I'll give you one specific example. So my disease of interest is AML, acute myeloid leukemia, and for AML we hadn't had any new treatments approved. Our original therapies are the same ones we've been using since the 1970s. Our later therapies were approved about 20 years ago and there was nothing, and through early phase clinical trials we were able to bring new treatments to our patients. But what's amazing is that in that time period, you know, we had very few advances, but in the last two years we've had eight new drugs approved for AML and we had clinical trials of every single one of those drugs available through the CRC and through our main campus. We were able to bring the latest and greatest, the most innovative treatments to our patients right here in town, long before they were FDA approved and available. So we brought the right drugs to the patients earlier. Our entire team is trained on how to use these drugs earlier because we know the side effects and we have a lot of experience with them, so we're really able to integrate these new treatments into our standard of care as soon as they're approved.

Dr. Roy Jensen: So is there anything else like the clinical research center in our region?

Dr. Tara Lin: As the only NCI designated cancer center in Kansas, we have the only dedicated phase I unit like this. And certainly in my conversations and discussions with colleagues at other cancer centers, no one's got anything like this with the level of community support that we see. In the last year we put 145 patients on early phase clinical trials and as of July 31st, we had put 150 patients on early phase clinical trials already this year. So we're already going above and beyond what we did last year and we've still got several months to go. It really just shows the way that the entire cancer field is moving towards smarter early phase clinical trials and why we feel it's so important to have those available here in town for our patients.

Dr. Roy Jensen: There's absolutely no question that under your leadership, and Joaquina Baranda and Steve Williamson, our accruals have really taken off. So I want to set the stage a little bit. Back in in 2008 there was this little thing we call the great recession and I'm quite certain that you factored that into timing of this election.

Mary Birch: Totally timed, totally planned.

Dr. Roy Jensen: Yeah. So it was like, what, six weeks after Lehman Brothers-

Mary Birch: It happened in October.

Dr. Roy Jensen: ... went bottoms up, and of course everybody wants to pass a tax initiative when their 401ks are bottoming out.

Mary Birch: Exactly.

Dr. Roy Jensen: So tell us a little bit about kind of like the climate and what this election said about Johnson County and what ... you know, you talked about their focus on the future. Tell us a little bit about that.

Mary Birch: Well, I think that the biggest part about what happened was that recession and because we hit that point and said, "We have no idea. Will they invest in the future of this community?" They always have, with the community college, K-12, and so on, but will they invest based on degrees in research and animal health and food safety. And literally it passed by 57%. We had looked at a higher number early on, 58% which was, you know, we were joyful when that happened, but it did show that Johnson County is willing, number one, to buy into visions of the future for this county and grow its life sciences economy but, for the most part, help people be cured of cancers that we've never had that opportunity. You know, it's one of those things that the uniqueness of this is still unique today because it's not being done anywhere else. That's number one. Number two, the beauty of it is one, sales tax will continue to grow in Johnson County as we continue to grow in population, but also it's permanent and therefore it is a very safe, plannable, predictable revenue stream for the cancer center to do bricks and mortar and scientists and for K State Edwards to do degrees and K State Olathe to do degrees. So it really, I think, has had ... and we're only 10 years old, so, you know, a lot of people, "Oh my gosh, oh my gosh. What all has gotten accomplished?" A lot has gotten accomplished in a short period of time, but it's forever. And so I think that's an opportunity for Johnson County to have contributed to that piece for our community and bring in all that talent that you guys have been bringing in and that kind of thing. So it still is very positive. The thing that is worrisome is the leadership leaves, and we've had leadership from the university level that retires. We've had leaders who made this thing happen retire. So it is a job for JCERT to market itself as to the things that it's working on, but most importantly, the cancer center.

Dr. Roy Jensen: Mm-hmm (affirmative). So when I talk about JCERT to other cancer center directors across the country, they're absolutely dumbfounded that one, we even had this idea, two, that it's wildly successful, but the thing that always gets them and they just, you know, it just absolutely kills is when I point out that the election was in 2008 and they just shake their head and they say, "I can't believe this because how could the voters of Johnson County set all of that aside and just say, "You know what? We're focused on the future."" And that was, I mean, it's just incredible. So we're delighted to have you on today-

Mary Birch: Thank you. This has been wonderful.

Dr. Roy Jensen: ... and we're doing so in celebration of the fact that it's been 10 years now, which is hard-

Mary Birch: That went fast.

Dr. Roy Jensen: ... to believe, and so I want to ask both of you this question. In this last decade, what would you like our viewers to take away in terms of the lessons of JCERT, maybe for you, Mary, focusing on that, and Tara, if you could focus on what it's meant to the patients of the KU Cancer Center, and we'll start with you, Tara.

Dr. Tara Lin: I think certainly to have such an amazing level of support, an incredible facility when people come in, their jaws drop that we have a dedicated phase I unit. It's not the corner of some floor in a non-used building. That we have dedicated pharmacist to early trials, dedicated nurses to early trials, dedicated lab staff, clinical trial staff just dedicated to this initiative is really something else. And the fact that we've been able to treat so many patients over this time period and to be able to keep them at home, I think is really the most important piece of it. All of us live here. We have families and neighbors who develop cancer and we want the best treatment for them and we don't want them to have to leave Kansas City and go someplace else and have all of those extra burdens compared to what they're already going through. So to think about each one of those individuals that we've been able to touch over this time, how it extends not only to what we're doing to treat their cancer, hopefully cure their cancer, but also to allow them to be able to stay here in town with their families and neighbors and that support system is really something amazing. It makes our job so much easier when we're able to completely support that person right here at home.

Mary Birch: Yup.

Dr. Roy Jensen: So Mary, what would you say?

Mary Birch: Well, I think a couple of things. First of all, this was developed as the perfect storm. We hit tons of walls and if K State ... if Olathe hadn't given K State the land, if Edwards hadn't really worked for what they wanted, if we hadn't talked to you to say what piece is needed for NCI, none of this had happened. And at the very end-

Dr. Roy Jensen: And the Hall Family Foundation.

Mary Birch: Bingo. And the very end, we had everything set up and I was literally hysterical about the fact we couldn't find a site. We couldn't put it on the ballot without a site. We had no site and the Hall Family Foundation stepped up and said, "If the tax passes we're in and we're going to help with the facilities." And so without all of those pieces ... the legislation came close. The vote wasn't that close considering, but considering the economy it was. So I think the ability of Johnson County is to dream and that's what this was, was a dream. It's going to evolve. It's going to change as markets change and things happen and that's okay because future leaders will figure that out. On a personal basis, I'm a cancer survivor. I found my new passion when I was diagnosed and I can't think of any place better ... there isn't any place better in my world to having our people, our own people, have access to new clinical trials, to new drugs and et cetera, and to be able to capitalize on the amazing school of pharmacy we have.

Dr. Roy Jensen: Once the tax passed, we went through an incredible due diligence process in terms of going and visiting the best phase I facilities across the country and getting their expertise and asking them how to design the facility and what would be their ideal setup to put a phase I program or early phase program forward. And we were able to benefit from all that advice. And you know, Steve and Tara and Joaquina have all done an incredible job of making sure that we bring a huge amount of value to our patients, and when ... you know, one of our major selling points was the fact that for all intents and purposes, Kansas City had very little access to phase I clinical trials when we got started. And that's because it takes a lot of infrastructure to do that. You have to be in a position to convince pharmaceutical companies that you have the wherewithal to put on these trials, to successfully recruit patients, that you have the clinical expertise to run the trial, that you have all the regulatory and everything else. And that's what JCERT allows us to do. You know, many cancer center directors would tell you that one of the banes of their existence is the clinical trials office because they're just an endless money sink, and frankly through the support that we get from JCERT, it's one of our brightest shining lights because we have the capacity to have absolutely one of the best clinical research programs in the country. It's solely attributable to the fact that we have JCERT, that it's predictable, it's sustainable funding, and we can really think about the future of our clinical research program and plan accordingly.

Mary Birch: It's also growing faster than what we thought it would. We were supposed to be 20 years out before you were getting $6 or $7 million. So that's really good news. I mean, it helps you at least sustain the maintenance part of it. But yeah, not just the uniqueness but really the ability to find two pieces that can work together so well and that fit Johnson County thinking, and Johnson County thinking was bold and dreaming and visionary. On one side, it's our ability to treat cancer patients right here, our own people, and within the doughnut you talk about. But secondly, it is a very large contributor to the economy of this county, which helps it continue to grow. From that perspective that brings in more sales tax to helps us help us with the clinical research center.

Dr. Tara Lin: Traditionally, phase I programs were on the East Coast and the West Coast and I'd have a patient come in and I thought they needed something that was newer and cutting edge and you would get online with them and you would look up early phase trials in their disease and you would have the conversation. Do you have any cousins on the East Coast? Do you have an old roommate who lives in Chicago or New York or San Francisco where we could send you, because there was no option within a reasonable distance for people who live in the middle of the country. And it's an accident of geography where you live and where you're born, and so it shouldn't be that only people on the East and West Coast get access to the latest cutting edge clinical trials. It's a real duty, I think, for us as physicians and cancer researchers to do everything we can to make those opportunities available for our patients at home.

Mary Birch: Exactly.

Dr. Roy Jensen: You know, one thing that we haven't talked about is that the rise of the CRC and JCERT more or less coincided with a revolution in our thinking around phase I clinical trials. And you know, back in the 1960s, 70s, 80s, even well into the 90s, most phase I trials, about the only information you got out of those was determine a dose to go further with a trial and figure out if you wanted to move ahead with that drug. This is not ... today's phase I trials are not your grandfather's phase I trials and you know, a great example is Gleevec. From the very first trial that drug was in, it put people on the path to a normal lifespan, and that is not how it used to be with phase I trials. That, I believe, increases the importance of this facility to our patients even more so because you cannot practice cutting edge, or even I would say standard of care or best in class medicine without access to a phase I clinical facility because that's where the excitement is. That's what is making progress against this disease and so we're really blessed here.

Mary Birch: Well that kind of goes back to my buy in into cancer was our trip to Seattle, Washington when you introduced us to the Fred Hutchinson Cancer Center and we were talking about Nobel laureates and what you and Dr. Hemenway had already launched a 10 year plan as to what we needed. That was kind of where I kind of figured out number one, research is an economic engine, which I had not put that together, and number two, again, the donut hole that we had gave us an opportunity here to really be able to help people deal with and survive cancer.

Dr. Roy Jensen: That's a great way to end up today's segment. So I want to thank you both. That's it for today. To learn more about clinical trials, visit kucancercenter.org/clinical trials. Join us next week at 10:00 AM for Bench To Bedside. Thanks for watching.