Clinical Trials

Dec 30, 2012|

The Roswell team discusses clinical trials

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Automatically Generated Transcript (may not be 100% accurate)

This is -- wellness -- by Roswell Park Cancer Institute. European opinion where your total options. You're hosed him -- welcome back to Roswell -- instant comprehensive look at all aspects of cancer care treatment diagnosis. And today. We're gonna talk a lot about research from a comprehensive source Roswell Park Cancer Institute here in Buffalo, New York. I'm -- Wenger and today new clinical trials and research we'll talk about it with doctor Alex RJ. He's in studio today he's the -- and enjoy a chair in cancer medicine and the senior vice president of clinical research. Here at Roswell park doctor -- thanks for being here. You're welcome to -- title got a lot to talk about today and there's an awful lot that goes on and on your area of expertise some looking forward to it and now with you today. Doctor -- -- -- associate professor in the department of medicine and an assistant member in the tumor immunology program here at Roswell park. Doctor Wang thank you for being here thank you very much for the invitation lots to get to here in week we talked so much on this program and so much in this community about the great work at Roswell park does. And oftentimes. We're talking about the clinical. Treatment of patients but that treatment wouldn't be real it wouldn't be here and it wouldn't be of the stature it is. Today. More tomorrow. If it wasn't for. Clinical trials in research it's a key. Part of what you do here Roswell park doctor -- Why is this so very very important. What their main reason as everybody knows. Congress it's a tough disease two oh and if you think back twenty phase two years ago we -- -- doing well at all there have been a lot of progress is that an. And this is all because of clinical trials so the idea. Behind a clinical trial is you have and new design is all new old Rock Island new proceeds via. That looks promising and you would take inmates in two patients and testament to these shows that you relax and their whole goal is to. Improve -- well we already house. What should people know about it is simply the phrase clinical trial. If you're patient or the family of appeasement and you hear that phrase clinical trial I don't want my. Loved one my spouse my son daughter whatever might be. To be in a trial I want a sure thing. Explain to us what. Clinical trials are and how they play a role in the treatment of cancer. So. -- to make this quick in general we talk about three phases of clinical trials. And their most important within four and if I remember in the patient to understand is that. And that point in time when you all physician recommends a clinical trial is is that their best option value Hobbs. All leads -- optioned back in their view of that Clinton it. And clinician on and that medical community is -- -- going to be wise and what you would normally gets you should. Stand about treatment so passive way. No oncologists in this country in general particularly. In a comprehensive cancer center of that is overseen by atlas America listens to Q. Is going to Arafat and treatment. Dave -- are suspect's mind of the school and swore you -- house. From regular treatment so we generally. When we have area -- Moscow's subway that treatment to -- -- and well you find that you don't -- many clinical trials. As a serious way and treatment as no way could very well. And so about -- what we'll talk about leukemia a disease that is it tough to beat. That treatment is we have not been around for a long time and so as a great need for improvements in so you find that. That. Must also an awful ideas come into the Kenya whole idea behind all these clinical trials is to improve. While we go -- people. We get into some of those specifics and -- -- factor weighing his Kennedy's -- -- is gonna really share with us here. I think you're still there's there's a real curiosity about what you said then that oftentimes a clinical trial is the best scenario for patient not. Just an alternative the best. A way that that we can treat a particular. Disease. However I know that you know -- -- there's so much regulation and oversight is there should be wouldn't do it with medical care and in in this case cancer care. How how do one of these trials get to the point where. You know you can offer me something that's better than what's being done every. -- so so so so that's three. Classes I'll talk about phase one the phase one trial is. When you have a brand new drug usually has sucked tucked him in new pro team that -- them -- that we have but toxic. And we've done all the studies in that number retreat to show that it's safe. And we try and it didn't patience for the fast time so typical of -- is one trial you go into how. Somebody what effect -- -- who's doing well. But house gone through all this time about treatments that they can get so -- now as this new drug. Our promises. To help him as police and let -- -- now options. Sol dot Steffi is one trial also fought somebody who was being closed today for phase one trial. It's that -- option to -- -- one of the few options left that might be helpful. Seoul. Dot group is different now -- phase two trial. Is when that -- has gone through phase one on soul is being tested in and number all -- pieces from different diseases. And we've identified. May be true story all fall when this drug is should we -- -- promise. And now we have testament to specific diseases so typically. When -- going in in that phase to a steady iron game. Your disease might be in about groupware system that treatment doesn't mean it went well and we look for something about it. You have this -- -- house in enough information to such as much better about what you read the house. And and from trees that are the phase -- he goes to phase three so that's his story then is a big study when you amount went home pandas. New treatments. To the old treatment. In their lives in the ball -- says it wants it passes phase three. Then that drug gets approved. So again in phase three. You don't test and you just random drug wave and you -- woods -- that and you won't be bad sometimes. That new one may not be back -- about these days because of that viruses and signs. Typically when we say this is that it trial. Wasn't successfully. Means that and you drop was no back -- about the old ones that very few cases where I knew drop. Will be Wess back on the old one so when you gonna phase three trials as I hope that. He'll win to going to treatment that's bad to have done that why -- how do you slow biggest advantage these days is that. And early on in that trial you have a separate couldn T. Don't know cuts they've formation and decide what about this new drug is broken promises and may be that we're planning to treat -- thousand people. 500 on the old drive 500 on the new drug. I have done 12100 -- -- -- treat that dot com if you will look up information and see about this new drugs and to be much much better about your old ones in that case. Dot study will be stopped and all that people way get to that regular treatment will be that fancied that while the damage -- One that you want. Wait before I guess approved by the FDA. And it becomes available to everybody salt almost always an advantage don't go in clinical trial is that sounds -- you'll get something. -- -- Friend though me and I'll stop here of the -- about them is that. That advantage on the it would become a trial is that everything is control you know so everybody -- streets and the same way. Everybody -- it seems -- so if you adopt our value of trust. And Robin so long is not available and then you know that comes in general wouldn't change and -- -- -- -- -- -- and also you get. Excitement can bring missiles was given it that's something that can be very important for somebody will analyze the. And and disease accounts let's bring in your colleague doctor -- playing and we're gonna get real specific about a couple of the studies that are are close to your heart that your. Overseeing defense that the press sort of putter developed. But on this broaden the conversation that we're having about the clinical trials you deal with patients from all the time. What -- what's the response when when you present. Patients and patients' families. With the fact that there are clinical trials available to deal with their particular cancer. Well I'm out leukemia doctors that's what I'd been doing the last ten years and I have to say that in leukemia medicine. I'm all of our standard treatments for leukemia are based on the results of clinical trials so everything I -- today. To try to cure my patients with standard chemotherapy. Is based on the shoulder of giants fans of numerous hundreds and hundreds of patients. Some of them children. Who went an enrolled. On clinical trials. Some of whom survived some of -- said didn't. But the results of those clinical trials have led to the standard of care. And minefields and there are certain types of leukemia. Particularly pediatric her childhood leukemia is that now -- days are 90% of our leukemia patients and those categories can be cured. And the 1960s say cure rate was going five to 10% so in the last fifty years every decade. The clinical trial results have resulted in improved outcomes for leukemia patients and we want to be part of that tradition moving forward and I tell my patients that when I offer -- a clinical trial my offering them the opportunity. To improve their odds. They're faced with a life threatening disorder they're scared they're nervous they don't know what to do. And I -- then this is the standard chemotherapy. These are the outcomes but there's a possibility that we can make those outcomes -- better for you. So I'd like to offer you an opportunity. To improve your personal outcomes as well as to improve the outcomes of hundreds of other patients going forward. If this treatment turns out to be in the new standard of care. So I offer them the opportunity to do that I think they're Roswell our responsibility is to push the boundaries we're not looking to just control the disease. We're looking to improve outcomes for future generations of patients and I tell my patients as they're willing to participate in that. They haven't practiced personal. Benefits from participating and they can help many many others -- line. -- -- getting past this her ability because I'm sure you get families and patients past this hurdle all the time and that is. Okay here's the standard bearer of care that might be offered in a number of places and how -- you know me here and elsewhere Russell park another. Hospitals and facilities. Here's the standard care -- here of the outcomes here as you said you've presented. Is a clinical trial. How do you get that patient to understand that. That what is going to the outcome could be as good or better. -- -- that going. We don't know that going OK but I can guarantee my patients set the minimum I offer them is the standard of care. And then and that is my obligation is not to the pharmaceutical company or what are my obligation is to that individual patient enough I feel that an individual patient will benefit from this. I'm not giving them less than a standard of care and giving them more of the standard of care. Better than standard of care as doctor -- said. The guidelines and the regulations for these trials are very closely written and very closely regulated. And I don't have a choice as to when I do some of those standard tests and it improves the quality of their care. Okay I said Annie points in the clinical trial. Or my colleagues stuck to. From the clinical trial or is suffering from some side effects of the drugs we take the patient off the trial. And we move them into another treatment modality our goal is to improve the lives of our patients. But not to put -- that risk we don't expose them to undue danger we monitor them very carefully if they feel at any point. That mean think that they should come up or stay at any point feel that they wanna come off the clinical trial they come on us now and I can stop the clinical trial. Or they expand not to treatment at any time they just say. I don't want and this is any mightily to go back to something else I said that's totally fine with me I appreciate your participation in this trial and we'll move onto another treatment. In most cases to you when you put someone on a clinical trial -- do you. Do you do you find it's the opposite that -- people stick with treatment and and and their their care actually an -- perhaps improves. Well many of the patients and again the judging can speak for the patients that he C. So a lot of the patients -- -- has failed other therapies or referred here because they have no longer able to tolerate other types of treatments. And putting money clinical trial. With agents that we personally I have developed in the -- can personally tell them that we have positive results I think is something that's very reassuring for them. I also think that it offers and then and the family members a measure of hope. Because in certain cases we've taken patients with very very refresh treat disease -- other people have given up on. Put them on clinical trials and given them extra time guaranteeing responses. That in the community and other practices they did not have those opportunities to did not have that extra time. So I think in some cases of clinical trials are giving patients hope. And time to spend with their loved ones which I think is important to remember over the holiday season. That sometimes even if we can give them additional years or decades of life just additional time and hope means a lot to a lot of individuals. -- doctor -- in New York a couple of trials that we're gonna talk about here in specificity. In just a moment that is doctor -- twang she's an associate professor in the department of medicine here at Roswell park. And an assistant member in the tumor immunology program. Here at Roswell this is Roswell -- and also with us today doctor Alex -- The -- enjoy it chair in cancer medicine and senior vice president of clinical research. Here at Roswell Park Cancer Institute doctor OJ yeah I'm reading and in some notes here prior to the show that 50% of the patients. In general who come through the doors of Roswell park. Could. Could participate in. Some sort of of clinical trial it's an amazing statistic I think means that. Yes yes that's true and and our goal is. To -- file the appropriate clinical trial to every patient. Again. One of that as we do you know about Steele questioned in terms of -- and one on this. Odd jobs asked later in that clinic -- -- them raise benefits. To make shield that these dual invest time and was. At pace and -- -- parents. Was involved it's. Did that comfort -- in -- to take -- to admit. And all of that said to me we elected -- is this normal course and yet when I love that says I'll also say it is that especially in mount. That clinical trials out of every regulate. So if you don't want has a clinical trial legal. Kenya for clinical trial in leukemia. To be available to patients in me is that. And crummy team made -- of -- it. Had PS and so on how we view of this and this community in combat. Different drives -- house. That says some -- -- then the additional -- that recess. And information to be she'll about two indeed this treatment of these -- we know is likely to be bad about that stand before it goes far. And then -- he goes -- all of these communities we have an institution that review bong. Which is made up often involve individuals one physician knows -- lay people. And didn't win too -- -- this study from the point of view of them patient and is it to grow some time you've taken to. Is it to complicate Ted -- you explained it well enough so mineral content from their patience -- point to make -- about it. Protected and -- you know as a physician and your enthusiasm to do something now help -- says you know. Maybe drawing that tube of blood -- -- of the need it threatens lives so before that clinic out trop comes through. Is gone through all these processes. And dependable way it is -- federal now. Food and Drug Administration house. Located at National Cancer Institute has approved it so is gone through multiple. Qualities which are completely outside the control of this physicians who then it. Soul in this country every patient and -- come to a comprehensive -- -- like -- law park can be very comfortable about. Every study. The house side too bad. It's a study has been reviewed by a bunch of physicians. Who all agreed that this is safe. And promise and reasonable kids tool as it. It's yeah I think we've pointed that out many times and shown it's so important that. Clinical trials research isn't something that he you know you just think up in the morning and in your perform in the afternoon it takes it takes years to. I get these things off of the ground and doctor Wang you have four. As I understand it's studies that are currently. Been running right now. You know in addition to everything else you're doing in treating patients it sounds like you know an awful lot to balance we wanna talk about at least two of those today okay tell me about. A couple of these clinical trial secure hero overseeing and you came up. Well both and I judge and myself an addition -- many other responsibilities we both run research laboratories and in their research lab we take cancer cells that have been acquired from prior patients. And we treat them with new drugs that have promised to destroy those cancer cells we tested -- -- test of regiments. We test whether those new drugs can successfully be combined with standard chemotherapy. And kill off those cancer cells and the laboratory. In my laboratory I studied human leukemia cells and some of those subpoenas so it's actually come from prior patients treated here Roswell park. I take this cancer cells my research looks at inhibiting the growth of them within the bone -- Mike from our men are that tumor micro Miami and which the cancer cells live. I've developed mouse models right infant leukemia cells in the animals and treat the animals sort of like. Trial of drugs in mice before they go into humans. And based on some of the day that that I personally have generated in the laboratory with my staff and my students. As well as data generated and other research labs such outages -- in particular. We have a couple of compounds that were really excited about common fact was so excited about them that we wanted to be the ones to bring them forward. To cancer therapy. So I -- I have designed to trial of the drug called -- she's 386. Which I partnered with the engine this company that makes the drug and asked that it be given as a potential treatment for patients with acute leukemia had -- had failed other treatment modalities. It's an outpatient drugs they don't have to be admitted they come to the clinic once a week. We give it in combination with the standard chemotherapy again which is injected at home. And we are looking to see whether the drug is well tolerated. And whether it can have some efficacy we have seen a couple of responses in patients treated to date. And the unique thing about this trial is because it's based in is written and designed -- me. It's only available to patients at this cancer center and at University of Rochester where we have a close research collaboration and I think that that is potentially. Going forward. Treatment modalities that we would like to explore more of what did it take to get to this point we're actually you know to the point of working with. Pharmaceutical. Provide here. And in you know actively recruiting and treating patients with this with this therapy. Well part of it is based on my clinical experience from coming to clinic in seeing patients that don't do well again and again and having no treatment options for them so there's a personal desire to provide something to them. That they keep that will help improve their lives the other thing is my intellectual. Contribution and thinking about drugs that might have potential in this arena. And bringing that idea forward in our laboratory studies and then looking and agents sent its attacks those and then moving into a clinical trial. That I personally can supervise and provide as an option for patients that don't have any other options. You that you used the word earlier uniqueness and in doctor. You know we've we all make decisions on our care at some point in our lives and you know hopefully it doesn't deal with cancer but when it does. We need to decide you know what type of facility we go to and we go somewhere that -- the standard of care and there's nothing wrong with that but it's the standard of care. Or we can go somewhere that offers these cutting edge. So to speak in new clinical trials and then I guess the next level and that the and what does doctor Wang said that that struck me is something that's unique even within that I mean the only place you can get the trial which he's talking about it here. Those unique trials I think are really important to where we're going with cancer treatment. Yes. And and because we have. A very comprehensive. Plan and lead drug development program. We tend to Ohio and lopped off about these unique products all. That. The unique drugs that typically. Even out and new drug that you put in in that clinic for the fast time. Or sometimes. It's bad drive that's already available. And you use and -- in different easiest way it's typically not used so all. And both of those situations system because it is on their institution and investigated as a as a one says it's -- and put -- an idea. Fall and treatment of what practical disease popular in ways sometimes that front comes in new war made a drug available. Funded trial also in phase one program which is at an early stage -- you break new drugs into that clinic. We have and -- studies that. Available only here Russell pock Wiehoff. Fall studies. We had going in ten minutes of those so all. Doubt theory had problems that we test an awful -- laws. That in this country -- country Ross well you can get to keep your eyes and France one of them the other one you can get to these guys in Italy. And the other one -- Probably a study with a group experience so how study saliva. We have a few that might be available in a couple of places in this country by its. He had in buffalo -- you have to go to Assange who is -- you have to go to San Antonio. You know offense line so those and leave studies that really important and I -- out on stage and come in to. Please across slow compared to maybe red -- college's police have a choice. You have multiple options I'll be discussed with you and -- -- and decide whether you want to stop and that treatment that you can get anywhere -- All of. He's unique studies doctor Wang you know if we do we do clinical we had Russell park do clinical trials and many you know different aspects of cancer. In your particular area of expertise and that that being leukemia. In blood cancers. If it's of particular importance is that. Yes I think that's blood cancers. Are hitting older individuals our population is aging here in the buffalo area and -- have literally for the most common type of acute leukemia. That strikes those individuals the standard of care has not changed since the 1970s. And we are dedicated to making that change. We're dedicated to bring the clinical trial opportunities here to buffalo to offered to their patients that we are treating. We do participate in other trials but I think it's important that our community in our city of buffalo. And our patients that are here have the opportunity to get some of these cutting edge treatments and that were designing better treatments for patients. You know it's really memorable -- for me today as we -- around the program out is he's what you said about you know in dealing with patients through your career. Fifty you kind of tired of of getting to the point with certain patience that -- -- there really weren't other options are different options so you come up within. Your own you know. Knowledge set an -- area of expertise in this being leukemia. Ways around and find new ways. I think that's my responsibility I think I don't wanna just give -- standard of care I want to give them options island and give them an opportunity as a sent to spend more time with their family. I always want to have a plan B now and I think that that's really important when you have a life threatening disorder. To know that there are many things that we can do you never wanna go to somebody that says I only have one option. You wanna go to somebody that is gonna give you multiple options and -- of new things that they contrived. When you have a disease like cancer you always have to keep trying. We'll keep going because we went plan CD EM I mean -- you think that I'm not enough value to him that I think I would like to have other options and I think I'd like to have more than one option. And I wanna have somebody that's coming up with new things and new drugs and new opportunities. To -- Think I absolutely agree thank you both for being here appreciate it thanks thank you -- doctor -- -- she's an associate professor in the department of medicine here Roswell park. And assistant member of tumor immunology program as well doctor IG thank you always -- -- and appreciated doctor Alex -- -- enjoy a chair. In cancer medicine and senior vice president of clinical research and that's what we're talking about today. Here on Roswell listen you missed any portion of the program or would like to hear others you can do so at the website Roswell park dot org have any questions for Roswell. Called them told free always available at 877 ask our PCI that's 877. 275770. Listen to Roswell this Sunday mornings at 630 young WB yeah. -- by Roswell Park Cancer Institute your team opinion for your total options on line at Roswell this god of war. Hanging. And hanging. Then.