Tag Archive for: clinicaltrials.gov

What Early Phase Gastric Cancer Trials Are Showing Promise?

What Early Phase Gastric Cancer Trials Are Showing Promise? from Patient Empowerment Network on Vimeo.

What are the latest gastric cancer clinical trial developments in early phases? Expert Dr. Jun Gong from Cedar-Sinai Medical Center shares updates about early phase clinical trials and advice to patients for being proactive in their care.

[ACT]IVATION Tip

“…it’s never wrong to ask if there is any available clinical trial no matter what setting or stage of disease. Whether it’s early stage or advanced stage, it’s always appropriate to ask every provider, ‘Is there a clinical trial that you see may be eligible for me or that you believe to be a better option than certain standard of care options?”

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Transcript:

Lisa:

Dr. Gong, can you speak to any early phase trials that have shown encouraging results for stomach or gastric cancer and in particular any of those related to metastatic disease?

Dr. Jun Gong:

So the exciting part about research in stomach or gastric cancer is that there are a lot of ongoing exciting developments in new treatment diagnostics almost every year. And so I think in terms of advanced or metastatic stomach cancer, some of the more exciting trials that have been ongoing and for which results are eagerly anticipated include novel targeted therapies. Here beyond HER2, MSI, EBV PD-L1. We’re looking at novel targets such as claudin. In fact, it is highly anticipated that the first claudin antibody will be available soon for all corners in the U.S. with the FDA approval of such a drug. The compound in question is called zolbetuximab, and here, it requires patients to be tested for claudin on their tumor biopsies. And this is a targeted therapy that’s able to be added to chemotherapy for patients with metastatic gastric cancer.

There are other novel targets such as FGFR2, which is a new target that has…also a targeted therapy that can be added to chemotherapy. This recently demonstrated exciting benefit in a Phase I/II clinical trial. Then we also have novel immunotherapies. We have early phase trials that are now investigating CAR T therapies targeting stomach cancer and specific markers of stomach cancer, including claudin as well. So those are some of the more exciting Phase I ongoing trials in the advanced stomach cancer setting. In the non-advanced or non-metastatic stomach cancer setting, they’re really trying to…the trials have really focused on trying to improve upon chemotherapy, leading up to surgery to derive better cures for stomach cancer. And here, the addition of immunotherapy to chemotherapy is an eagerly anticipated concept that is now playing out in clinical trials and in larger clinical trials and their final results are eagerly anticipated as well.

Lisa:

And do you have an activation tip, Dr. Gong?

Dr. Jun Gong:

My activation tip for this is it’s never wrong to ask if there is any available clinical trial no matter what setting or stage of disease. Whether it’s early stage or advanced stage, it’s always appropriate to ask every provider, “Is there a clinical trial that you see may be eligible for me or that you believe to be a better option than certain standard of care options?” And we as oncologists are always more than happy to look into these clinical trials and really give you guys a breakdown of what trials may or may not be considered.

Sometimes clinical trials, it’s important to realize that for a particular treatment setting, may not be available at our institution, but there are other institutions within the geography. If you are not geographically limited, even across the country where unavailable clinical trials may be available. We generally refer to what we call a master website. It’s called clinicaltrials.gov. And here it’s a very, in my opinion, patient friendly search engine where you can search your diagnosis and look at available clinical trials. And it’s very easy to have this streamlined approach and even filter out some trials that may not be eligible in collaboration with your doctor.

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How Can MPN Experts Help Inform Patients About Clinical Trials?

How Can MPN Experts Help Inform Patients About Clinical Trials? from Patient Empowerment Network on Vimeo.

What are optimal ways for myeloproliferative neoplasm (MPN) experts to inform patients about clinical trials? Expert Natasha Johnson shares how she prepares herself, her approach to informing patients, and how she reacts if she senses patient hesitancy.

[ACT]IVATION TIP

“…go on clinicaltrials.gov, search up MPN trials, and that will first clue you into could you be eligible and where are they being done. And then you can contact that center or ask about it where you’re being seen locally and just get information. You’re not committing to it completely. Minds can be changed at any time.”

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Transcript:

Natasha Johnson:

As a provider of MPN patients, I first make sure that I am educated on what clinical trials are available and out there. And then when I see patients, I offer these options. I’m a strong, strong advocate for clinical trials because if it wasn’t for them, we wouldn’t have the medications that we have today. And just in the last several years, we’ve had many medications approved for MPNs that we didn’t have 15 years ago, and all that was done by clinical trials. I have on firsthand seen benefits of clinical trials.

So I strongly encourage patients to be a part of that. If there’s hesitancy from the patient or caregiver, I would take time to dig into that and help to answer or alleviate fears that come along with that. It’s important that the clinical trial coordinator who knows specific protocols of trials very, very well, they can come in the room or spend time on the phone with the patient to answer any questions, to alleviate fears and allow that opportunity if a patient is open and willing to do it.

So my activation tip would be first of all, go on clinicaltrials.gov, search up MPN trials, and that will first clue you into could you be eligible and where are they being done? And then you can contact that center or ask about it where you’re being seen locally and just get information. You’re not committing to it completely. Minds can be changed at any time. The clinical trials are greatly, greatly, greatly beneficial and as I said, we have what we have today because of patients who participated in clinical trials 10, 20 years ago and then have given these great opportunities to patients now. 


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Accessing Myeloma CAR T-Cell Therapy Clinical Trials

Accessing Myeloma CAR T-Cell Therapy Clinical Trials from Patient Empowerment Network on Vimeo.

How has CAR T-cell therapy changed the landscape of myeloma care? Dr. Brandon Blue shares how this therapy has been a “game changer” in myeloma care, and how clinical trials for newer CAR T-cell therapies are advancing care and access for patients.

Dr. Brandon Blue is Assistant Member and Clinical Instructor in the Department of Malignant Hematology at Moffitt Cancer Center in Tampa, FL. Learn more about Dr. Brandon Blue.

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Transcript:

Katherine Banwell:

Dr. Blue, we know that the approved CAR T-cell therapies are for patients who have already undergone several lines of treatment. How has this therapy revolutionized care for myeloma patients?  

Dr. Brandon Blue:

Yeah. So, CAR T is really a game changer when it comes to multiple myeloma. I’ll tell you that previously people have seen a lot of the best medicines that we have, and unfortunately for a good percentage of people the disease just becomes what we call refractory.  

And unfortunately, despite us giving them the best medicines, the disease still likes to survive. So, we had to think of something of what can still kill cancer, but may not be the traditional chemotherapy that people may think of? So, we say, “Well, let’s come up with CAR T because it’s a way to actually use the body’s own immune system to fight off those cancer cells.” And for myeloma it really has shown a lot of progress. And one of the things that we know now is that not only do we have one, but we have two products, and maybe even a third coming down the pipeline because there’s more and more of this CAR T becoming available. 

And that’s better, and better for patients.  

Katherine Banwell:

Absolutely. That’s great news. For patients who are recently diagnosed, Dr. Blue, is there any chance of accessing this treatment sooner? Maybe through clinical trials. 

Dr. Brandon Blue:

Yeah. One of the biggest clinical trials that I think that people are excited about is trying to challenge something that we’ve been doing since the 1980s, which is stem cell transplant.  

So, typically, when a person get diagnosed with multiple myeloma, especially newly diagnosed, stem cell transplant is typically part of the treatment plan. But now there’s clinical trials that are coming out where we challenge instead of maybe a patient going to stem cell transplant, maybe they might do CAR T instead. And we’re trying to figure out can something that we’ve been doing since the ‘80s be un-throned as the best standard practice? And so, I think that’s something that people are really excited about, that’s something I’m excited about. 

And it gives people who are newly diagnosed a chance to get some of this novel therapy.   

Katherine Banwell:

I have a follow-up question about the clinical trials, you mentioned that there is one going on. Where is it taking place?  

Dr. Brandon Blue:

Yeah. So, it’s actually a multi-center study. And so, hopefully, we hope to have Moffit Cancer Center involved in that clinical trial, but it’s multiple different sites really all over the world because I think this is a question that everybody’s really excited about. Again, like I said, transplant has been happening since 1980s, and so for some treatment to come along to potentially challenge that, I think people are excited about a new contender. And we’ve already seen the progress that CAR T has already made. 

And so, the big question is how well will it work when someone is newly diagnosed before their body has really seen all the extra treatments that are there? Will it work even better?  

We’re very hopeful, and we’re very optimistic. 

Katherine Banwell:

Where can people find out about this particular clinical trial and other clinical trials?  

Dr. Brandon Blue:

Yeah. So, I tell people there’s so many different websites and resources. One of the main ones that is very readily accessible is clinicaltrials.gov, is very kind of easy, and intuitive. Typically, what you can do at clinicaltrials.gov is you can literally kind of just type in your disease process, and then they’ll tell you if it’s newly diagnosed, or relapsed. There’s also a place called SparkCures. SparkCures is fantastic organization that really tries to focus people, and get them matched with clinical trials, which is fantastic.  

There’s also HealthTree. HealthTree not only helps people from a clinical trial standpoint, but they also have patient support programs because nobody wants to be in the fight for cancer by themselves. The American Cancer Society does a fantastic job, as well as Leukemia & Lymphoma Society. 

The International Myeloma Foundation, or the IMF, and then the MMRF, the Multiple Myeloma Research Foundation. And there’s many more, but those are some of the top ones that we readily use that have a lot of information. And some of them have not only information for the patient, but also information for the family, and the caregivers. Because again, when someone gets diagnosed with cancer it doesn’t just affect the person, it affects the whole family.  

AML Clinical Trials Critical to Treatment Breakthroughs and Improvements

AML Clinical Trials Critical to Treatment Breakthroughs and Improvements from Patient Empowerment Network on Vimeo.

Why are acute myeloid leukemia (AML) clinical trials so critical? Dr. Naval Daver from the University of Texas MD Anderson Cancer Center shares his perspective about clinical trials. Learn how clinical trials help both current and future AML patients. 

[ACT]IVATION TIP from Dr. Daver:Clinical  trials are critical, both for the patients themselves to get access to what we call tomorrow’s medicine today as well as potentially to help move the entire field forward.”

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Transcript: 

Art:

Dr. Daver, what is the importance of clinical trial participation as it relates to breakthroughs in AML, and what advice do you have for AML patients considering a clinical trial?

Dr. Naval Daver: Clinical trials are critical for the progress that we have already seen an acute myeloid leukemia, the drugs that have been improved in the last six, seven years, including venetoclax (Venclexta), FLT3 inhibitors, midostaurin (Rydapt or Tauritmo),  gilteritinib (Xospata), hopefully quizartinib other emerging targeted therapies…IDH1, IDH2 inhibitors, menin inhibitors, CD47 antibodies, we’ve learned about all of them and have got approvals and many of them through the ongoing clinical trials.

I think it’s very important for patients to realize that in most large academic centers, we will only participate in the clinical trial if we think it has the potential to improve the standard of care in the future. There’s very little incentive for academic investigators or clinical investigators, such as myself, we’re very, very busy to get involved in a trial if we don’t think that it has the potential to improve the outcome or change the nature of AML therapy in the future, so a lot of patients often ask me, Oh, I want the randomized or placebo arm. There is no real placebo alone in any AML study that I’m aware of, most of the studies will use standard of care, which is what you would’ve gotten wherever you were getting treatment at home, locally, community hospital versus a standard of care plus where the new drug will be added, whether it’s the FLT3 inhibitor, the CD47 antibody, the menin inhibitor 

So there’s a good chance, 50 percent that you’re going to get standard of care plus that we think has the potential to improve the outcome, of course, you never know, that’s what you do, the trial, but we think based on the previous pre-clinical data to pass when the page to deliver this looks like it will improve the outcome for this molecular or site group versus standard of care, which is what you will have gotten.

So I think it’s important to realize that you will never get less on standard of care and any clinical trial, at least in the AML field, and at least in our experience that they understand. 

Now, beyond that, there’s also a Phase I in two states, and those are the ones that we focus on quite a bit at MD Anderson, these are single arm studies, meaning everybody will get the investigational agent combo, so azacitidine (Onureg or Vidaza) and venetoclax (Venclexta), we were one of the first sites to work on and leave this study and all of our patients in 2015, 2016, we’re getting this regiment, it was not approved to much later in 2019, 2020, and for those three, four years, our patients, hundreds of patients were able to get that combination, which probably cured many, many more than would have been cured to the standard of care until, of course, I’ve got a pro four years later, but for an option, of course, you cannot wait four years, so I’m a huge believer in clinical trials, I think it’s really, really important, both for the patients themselves as well as for the field, for us to be able to move the entire AML field forward for the next decade, and I would very strongly consider looking at or discussing with your treating physician trial options, and then you can look at them on your own through clinicaltrials.gov, or other sites with leukema and lymphoma that give a lot of information on clinical trials. 

So my activation tip related to this question is that I think clinical  trials are critical, both for the patients themselves to get access to what we call tomorrow’s medicine today as well as potentially to help move the entire field forward, all of the clinical drug approvals in progress we have seen in AML in the last six, seven years have come through clinical trials that patients in the past have agreed to kindly participate and helped probably themselves by getting better medications and combinations, and definitely the field to move forward, so definitely a big proponent for clinical trials. 

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Resources for Accessing MPN Clinical Trials

Resources for Accessing MPN Clinical Trials from Patient Empowerment Network on Vimeo.

What are credible resources for accessing MPN clinical trials? Dr. Angela Fleischman shares credible resources for MPN patients and advice for inquire about clinical trial participation.

Dr. Angela Fleischman is a physician scientist and assistant professor in the Department of Medicine at the University of California, Irvine. Learn more about Dr. Fleischman.

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Transcript:

Katherine:

What if an MPN trial isn’t offered at the center where a patient receives care? What can they do?  

Dr. Fleischman:

Many times, specific clinical trials are only open at specific universities. And so, it’s very likely that your university, or the place where you receive care, may have a few clinical trials, or maybe one, or maybe zero for MPNs, but may not necessarily fit your exact circumstances. 

So, what I would recommend is, doing searching on your own, either through clinicaltrials.gov, or the MPN Research Foundation also has some nice resources, but doing some research on your own to identify some potential clinical trials that you’re interested in, and then go to your primary oncologist and say, “Hey, I printed these out. I think these might look really interesting to me.” 

And usually, on clinicaltrials.gov, they would have where they are, and you can actually, also, search for your state. So, maybe bring some that are close to you, and discuss with your primary oncologist the pros and cons of them. And then, ask your primary oncologist to make a referral to the location where they offer that specific trial. 

And a lot of times, you can – there’s a phone number you can call and be pre-screened. Say, “Hi, I’m a 55-year-old man with myelofibrosis,” and there are specific inclusion, exclusion, criteria that they can ask you. And if you don’t meet the inclusion criteria, then it’s not worth your time to go and have an actual visit, but if you do meet the inclusion criteria, then you could go and have an actual visit, and learn a little bit more.  

Katherine:

Oh, that’s great information. Thank you.  

Multiple Myeloma Clinical Trials: Which Patients Should Participate?

Multiple Myeloma Clinical Trials: Which Patients Should Participate?  from Patient Empowerment Network on Vimeo.

When is the right time to consider a myeloma clinical trial? Dr. Mark Schroeder discusses when this may be an appropriate myeloma treatment option and shares patient resources for accessing and identifying clinical trials.

Dr. Mark Schroeder is a hematologist at Siteman Cancer Center of Washington University School of Medicine in St. Louis. Dr. Schroeder serves as Associate Professor in the Department of Medicine. Learn more about Dr. Schroeder.

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Transcript:

Katherine Banwell:

PEN community member, Mark, sent in this question prior to the program, “When is the right time for a clinical trial? When everything else is refractory?” 

Dr. Mark Schroeder:

No, I think clinical trials should be – you should engage your oncologist to talk about clinical trials right from the beginning. We typically think about clinical studies – they could be interventional where we’re actually giving a treatment. Some clinical trials are observational where we’re trying to learn about disease course in response to traditional therapies. Either of those may have direct benefit to the patient, or maybe it doesn’t affect the patient, but it affects future patients with myeloma.  

There are clinical studies like I mentioned that are moving therapies that are approved, but they’re approved after patients have been treated four or five times for their myeloma, and they’re now being moved earlier in the treatment. Some of those are at the initial treatment of myeloma in that induction phase. And so, we think that maybe by using some of these newer therapies or that immunotherapy class earlier on in the treatment of myeloma could result in deeper responses.  

We don’t know if it’s going to result in cures or that long remission beyond five or 10 years, but that’s the hope. If we can move the therapies earlier and prevent the cancer from becoming resistant to multiple treatments, maybe we can lead to longer remissions and longer survival of cancer patients. So, engage with your oncologist from the beginning through all of your treatment lines about clinical trials, is what I would say. 

Katherine Banwell:

Well, how can patients find out about clinical trials and what might be right for them? Where should they start? 

Dr. Mark Schroeder:

I mean, starting with your physician and having that conversation is a good start, but there are resources for patients. The Multiple Myeloma Research Foundation MMRF has good resources. There is a – called Myeloma Crowd that also has resources for patients with myeloma and social support for patients with myeloma to try to find and match you with a clinical trial. And then if you’re really academic and interested in doing your own homework online, all clinical studies in the United States, even internationally, are registered on a website called clinicaltrials.gov. Clinicaltrials.gov is – it can be searched, so you can search for myeloma; you can search for a specific drug.  

That will tell you, where are the studies being done, who are the study personnel, who should I contact to find out about the study? Unfortunately, not everybody can travel for treatment for their myeloma, and the best chance of potentially participating in a research study is to initially talk with your oncologist about it. There may be a larger center nearby that you can visit to consider clinical trials.  

Clinical trials that are trying to use the new immunotherapies would be a great option, but they may not be offered in, say, a community oncology practice. You have to have the infrastructure to conduct those studies. And if you have the resources to be able to travel, then finding something on clinicaltrials.gov and – I’ve had patients do the legwork and talk with their local oncologist and get referred to a center that actually has a study that they’re interested in participating.  

But a lot of times, studies are going to have you visit the center for all the screening tests and all the procedures for study. 

Katherine Banwell:

Right, so you have to know that you have the time available as well as the resources. 

Dr. Mark Schroeder:

Right, and the resources to do it. Yeah. 

Katherine Banwell:

Yeah. Trevor had this question, Dr. Schroeder, “My myeloma is considered high-risk. What treatment options are available to me, and are there clinical trials specifically for high-risk disease?” 

Dr. Mark Schroeder:

Yeah, great question. High-risk myeloma happens in about a quarter of patients, so one in four patients will have high-risk myeloma at the diagnosis. And it’s important because we know that when we say high-risk, that means that the myeloma is going to potentially come back sooner after treatments. It doesn’t mean that the treatment you’re going to be given is less effective, but it has a high propensity to come back sooner.  

Those patients with high-risk myeloma still benefit from a lot of treatments that we have for myeloma, but there are clinical trials geared to try and increase treatment in patients with high-risk myeloma to try to change the fact that their cancer comes back sooner than somebody who doesn’t have the high-risk features by using a novel chemotherapies or novel drugs to try to improve responses. So, there are for sure clinical studies, either at – potentially at initial diagnosis or at the time of relapse that could be entertained for patients with high-risk myeloma. And I would encourage you to seek those out for sure. 

Katherine Banwell:

Great. Thank you.  

Developing CLL Research and Treatment News

Developing CLL Research and Treatment News from Patient Empowerment Network on Vimeo.

CLL expert Dr. Michael Choi provides his perspective on the goals of current CLL clinical trials, discusses approved inhibitor treatments, and shares credible resources to keep up with the latest news in research.

Dr. Michael Choi is a hematologist and medical oncologist at UC San Diego Moores Cancer Center. Learn more about Dr. Choi. 

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Transcript:

Laura Beth:

Dr. Choi, are there recent advances in CLL treatment and research that you are excited about?  

Dr. Choi:

There’s certainly a lot to be excited about as far as new treatments or new understanding of our treatments. What I see as kind of two main aims of trials right now for our patients with CLL, one is to figure out the optimal way to treat patients, especially in the first line of treatment.  

For the past few years, we’ve had two very clear options, two very clear standards, a BTK inhibitor or the combination of venetoclax and a CD20 antibody. And so, right now, there are a couple of trials both in the states and internationally that are for the first time really comparing those head-to-head. At UCSD, we’re eagerly hoping to join one of those trials as well, and so this will help us and help our patients kind of really know which of those options make the most sense for maybe different subgroups of patients.  

I guess the other main emphasis is to have new therapies available to patients in case these existing standards stop working. And fortunately, this is not a common occurrence. Resistance to BTK inhibitors and Bcl-2 inhibitors is not common, fortunately. But we have to be ready with something if that does occur for our patients.  

Certainly, there’s a lot of enthusiasm for the next generation of BTK inhibitors, cellular therapies like CAR-T therapy, and other classes of medications. So, while I hope most of my patients never need those drugs or never need those trials, I think it’s important that we have those available.  

Laura Beth:

How can patients keep up to date on developing CLL research?  

Dr. Choi:

Oh, that’s a great question. I guess I sometimes ask that same question of myself. How can I stay updated on all the developments and discoveries. Yeah, I guess, yeah, certainly talking to your doctors about what other options there may be. Sometimes, that’s maybe the simplest question to ask.

Yeah, I wish online things were a little bit more straightforward. When I go onto clinicaltrials.gov, I pull up hundreds of different CLL trials, some that might not be relevant for all of my patients. I think The Leukemia & Lymphoma Society and other societies and your group as well have done a great job communicating what some of the most promising areas of research are.  

Educational Resources for CLL Patients

Educational Resources for CLL Patients from Patient Empowerment Network on Vimeo.

How can chronic lymphocytic leukemia (CLL) patients learn more about their disease? Dr. Seema Bhat recommends resources and online communities for CLL patients looking for more information. 

Seema Bhat, MD is a hematologist at The Ohio State University Comprehensive Cancer Center – The James. Learn more about Dr. Bhat.

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Transcript:

Katherine:

Many CLL community members are interested in learning more about their disease. So, for newly diagnosed patients, what are a few educational resources you recommend to help them learn more about their condition? 

Dr. Bhat:

There are a number of well-established support groups or educational resources for our patients. These include the CLL Society, The Leukemia & Lymphoma Society, Lymphoma Research Foundation, and then we have Patient Empowerment Network, and we have Patient Power. All these resources provide support groups, organize webinars, and have educational material for our patients. 

Katherine:

What about patients who have been living with CLL for many years, or are quite knowledgeable about their disease? Are there more advanced resources for patients to stay up to date on the latest research and treatment? 

Dr. Bhat:

So, for patients who want to search for additional resources, especially looking for clinical trials, going on this website called clinicaltrials.gov, they can first search for CLL-related clinical trials. Also, NCCN, or “National Comprehensive Cancer Network,” has patient resources for each disease, and then they can find information on CLL there, also. I would also like to say that Google is a good resource, as long as you know where it is taking you. 

Katherine:

Exactly. You may not be able to rely on everything you find. 

Dr. Bhat:

Right. 

Key Questions for Prostate Cancer Patients to Ask Before Joining a Clinical Trial

Key Questions for Prostate Cancer Patients to Ask Before Joining a Clinical Trial from Patient Empowerment Network on Vimeo.

Dr. Andrew Armstrong, director of prostate cancer research at the Duke Cancer Institute, provides expert advice on what questions prostate cancer patients should ask when considering participation in a clinical trial. 

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine Banwell:

What are some key questions that patients should ask their healthcare team before even participating in a clinical trial?  

Dr. Armstrong:

I think number one is what are the alternatives that I would have if I did not participate in the clinical trial? What are the standard of care therapies? And prostate cancer now has a vast menu. There is two different types of chemotherapy. There are two different types of target radiotherapy, that’s Pluvicto and radium. There’s immunotherapy, with Sipuleucel-T and other immune therapies. There are multiple hormonal drugs. There are precision medicines, like I mentioned, for men with certain hereditary types of prostate cancer. So, it’s important to hear what the standard of care is, and many patients don’t necessarily even hear that. 

And then based on what patients have already seen and what’s the expectation? Risks and benefits around those. 

And then on top of that, research can complement that or either replace or come after those standard of care approaches. Certainly if a patient has exhausted the standard of care approaches, a trial can offer real benefits. 

It’s important to ask about risks. What have other patients experienced going into that study? What kind of toxicities, good or bad? What other – what’s the evidence that it has helped people before? If it’s never been studied in people, the evidence might just come from the laboratory. But hearing about why is this so promising, why have you chosen to invest so much time and energy in this trial, is a good question. 

And then if you’re hearing about a trial and you’re making a decision to travel, sometimes asking questions about whether the trial will cover your lodging or transportation, gas money, airport travel. Some trials do do that. 

You can also look on clinicaltrial.gov for sites that are near you. So, many centers open the same trial in a different state, so you can look on that website to see if there’s a trial near you for what you’re looking for.  

How Can Prostate Cancer Patients Access Clinical Trials?

How Can Prostate Cancer Patients Access Clinical Trials? from Patient Empowerment Network on Vimeo.

Dr. Andrew Armstrong shares trusted resources for accessing information about prostate cancer clinical trials and reviews common barriers to participation.

Dr. Andrew J. Armstrong is a medical oncologist and director of clinical research at the Duke Cancer Institute’s Center for Prostate and Urologic Cancers. For more information on Dr. Armstrong here.

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Transcript:

Katherine Banwell:

Yes, yes. How can patients find out about a trial that might be right for them? 

Dr. Armstrong:

There’s several sources. One is through their doctor. You know, their doctor can be their navigator. They will be connected either within a cancer center or be connected to a cancer center that’s in their region. So, getting a referral to a cancer center can be that open door to hearing what trials a big cancer center might offer. 

If patients are willing to travel longer distances, there are websites like clinicaltrials.gov where patients can search and find a trial, find a coordinator, find a principal investigator or doctor, contact them, and then either drive or fly to that site to access that trial. Not every patient has that means. 

But that’s certainly a resource that many patients and their family members can use to seek out those trials. And I certainly have patients that have found me in that way. 

But it’s probably more common for patients to come to you through a referral from their doctor because many sites in the community don’t have access to those clinical trials, but they know who does.  

Katherine Banwell:

What are some common barriers to accessing clinical trials? 

Dr. Armstrong:

The most important one is probably transportation. Some trials are close by, and some trials are very far away, and resources can be a major barrier. The cost of transportation, of having to be near a trial site, can be a major barrier. We wish we had all of the trials everywhere, but that’s not possible. Some trials are available at Duke, but are not available for example in Baltimore or Boston or California, and vice versa.  

Each academic institution may have their own trials. There are going to be some big trials that are available everywhere. These are like global Phase III studies. And really just talking to the physician, maybe getting a second opinion about which trial may be right for you in a certain circumstance is really part of the shared decision-making process. 

So, travel, socioeconomic status, cost concerns, those are barriers. But most clinical trials will pay for the experimental drugs. They will not charge you more money to participate in the study. And most insurance companies will pay for your participation in that trial, so that should not be a major barrier, but transportation can be. So, sometimes patients will find trials near a loved one or a family member so they can stay with them during the trial participation. 

The Benefits of Participating in a Myeloma Clinical Trial

The Benefits of Participating in a Myeloma Clinical Trial from Patient Empowerment Network on Vimeo.

Myeloma specialist Dr. Abdullah Khan discusses why myeloma patients should consider joining a clinical trial, addresses safety protocols for trials, and shares how participation in research advances medicine.

Dr. Abdullah Khan is a hematologist specializing in multiple myeloma and plasma cell disorders at the Ohio State University Comprehensive Cancer Center – The James. Dr. Khan is also an assistant professor in the Division of Hematology at The Ohio State University. Learn more about Dr. Abdullah Khan.

See More from Myeloma Clinical Trials 201

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Transcript:

Katherine:

I’d like to turn to clinical trials now. Why should a myeloma patient consider participating in a clinical trial?  

Dr. Khan:

The main potential benefit to a patient includes getting a new treatment for a disease before it’s even approved for other patient with multiple myeloma. Sure, clinical trials have risks and benefits, but participating in a clinical trial is probably also safer than ever.  

What I mean by that is clinicians that participate in clinical trials are required to follow very strict rules and guidelines to make sure the participants are safe, and these rules are enforced by the federal government. Each clinical trial also follows a careful study plan, or protocol, and that describes what researchers will do and when they will do it. 

And the principal investigator, or the lead researcher, for that clinical trial has the responsibility that the protocol is followed at every site that the study is available. So, generally, that also means participants will get more frequent health checkups as being part of the clinical trial. And by volunteering for a clinical trial, patients are helping themselves and also the general society for patients afflicted with multiple myeloma.  

Katherine:

Right. Everyone who comes after them would be impacted. Why is patient participation in myeloma clinical trials critical to advancing research?  

Dr. Khan:

Clinical trials help researchers better understand health and disease. Clinical trial participation is actually considered the gold standard of providing medical healthcare.  

And, in fact, every therapy that is currently approved for myeloma right now is a direct consequence of participation of brave volunteers.  

Where Do Clinical Trials Fit Into a Non-Melanoma Skin Cancer Treatment Plan?

Where Do Clinical Trials Fit Into a Non-Melanoma Skin Cancer Treatment Plan? from Patient Empowerment Network on Vimeo.

At what point should advanced non-melanoma skin cancer patients consider participating in a clinical trial? Dr. Anna Pavlick discusses the benefits of trial participation and how the eligibility process works.

Dr. Anna Pavlick is a medical oncologist with over 20 years of experience treating patients with skin cancer and is the founding Director of the Cutaneous Oncology Program at Weill Cornell Medicine and NewYork-Presbyterian. To learn more about Dr. Pavlick, visit here

 

Katherine:

Where do clinical trials fit into the treatment plan? 

Dr. Pavlick:

You know, for me clinical trials are something that patients need to see as an opportunity. 

It should always be the first question that a patient should say, “Hey doc, what about a clinical trial?” Clinical trials provide patients with such great resources to either get a standard therapy with something extra, or to look at a novel way of using a known therapy. I think it’s something that every patient should ask their physicians about – and not everybody is eligible, or should go on a clinical trial – but it’s certainly worth asking, “Is there a clinical trial that I could participate in?”  

Katherine:

So, who might be eligible? What’s the criteria? 

Dr. Pavlick:

Well, each trial has different criteria. So, depending on the trials that are available at the institution where you’re being seen – for example, if you have, let’s say, basal cell cancer – the clinical trial may be looking at two immunotherapies as opposed to one immunotherapy. So when we do a clinical trial, there are what we call inclusion and exclusion criteria, and those are pre-determined criteria that you have to check those boxes to make sure those patients fit that particular study.  

So it’s not a random, “You can’t participate because you’re wearing a purple shirt today.” It is, “You have basal cell, but you have never had this drug that the study says you have to have been treated with this drug in order to go on to this study.” So you can’t jump from A to Z. You have to go from A to B to get to C. So, it really is just checking the boxes, making sure that patients fit whatever the deemed criteria are, and make sure they also don’t fall into the exclusion criteria. 

You know, trials will also say, “If you have an unstable medical condition –,” you know if I have a patient who’s telling me that they’re in and out of the E.R. with chest pain because the doc thinks that they have unstable angina and may need a stint – well, that’s not a patient that you want to put on a clinical trial at that point in time. Not to say that it can’t be re-explored at a different point, but people with active other medical issues just add to the complexity of being able to determine what are the side effects, and what are the not – what’s related to study drug, and what’s related to underlying problem?  

When Should Advanced Prostate Cancer Patients Consider a Clinical Trial?

When Should Advanced Prostate Cancer Patients Consider a Clinical Trial? from Patient Empowerment Network on Vimeo.

Where do clinical trials fit into a prostate cancer treatment plan? Dr. Rana McKay shares her perspective on when patients should consider trial participation, as well as the benefits of joining a trial.

Dr. Rana McKay is a medical oncologist at UC San Diego Health and an associate professor in the Department of Medicine at the UC San Diego School of Medicine. Learn more about Dr. McKay, here.
 
 

Katherine Banwell:

When should a patient consider a clinical trial as a treatment option? 

Dr. Rana McKay:

So, I generally think that a patient should consider a clinical trial at almost every juncture that a – a clinical decision is being made. I think sometimes there’s this misperception that, “Oh. Clinical trials should only be utilized when I don’t have any other options.” Where, in fact, I would say clinical trials should be an option to discuss every single time a treatment is being changed. Because you know the ultimately the goal is to make sure patients are as I said, living longer and living better and, you know, making sure that clinical trials are an option on the table at every juncture is really a key step in that process. 

Katherine Banwell:

What are the benefits of being part of a clinical trial? 

Dr. Rana McKay:

So, I think there’s a lot of benefits. I think, you know, for patients with advanced disease it may provide access to drugs that they otherwise not necessarily have access to. So the standard of care therapies you know, we can prescribe those at any juncture. They’re standard of care. But clinical trials really offer an opportunity to experiment with another agent and doesn’t necessarily take away from the standard of care options.  

I think the other thing is you know, I think a lot of patients with advanced prostate cancer, they – want to give back to the community. They want to leave a legacy. They want to contribute to the science. They want to be a part of that mission to make tomorrow better than today for men with prostate cancer, and I think participating in clinical trials can really help achieve that goal and also benefit the individual as well. 

Katherine Banwell:

What about emerging treatments? Are there any that patients should know about?  

Dr. Rana McKay:

Absolutely. So, there’s a lot of treatments that I think are currently undergoing extensive testing. There’s additional targeted therapies, for example, CDK46 inhibitors that are being tested broadly in the hormone-resistant space and the newly diagnosed setting. There’s also AKT inhibitors. There are other targeted therapies that are being tested. There’s novel hormonal treatments that target resistant pathways like the antigen receptor degraders. There’s a slew of immunotherapy options cell therapy, bi-specific antibodies that are also being tested. So, there’s a lot of really exciting and novel treatments that are looking at overcoming resistance for people with advanced disease.  

Understanding the Role of Clinical Trials As a Myeloma Treatment Option

Understanding the Role of Clinical Trials As a Myeloma Treatment Option from Patient Empowerment Network on Vimeo.

When it comes to myeloma treatment options, where do clinical trials fit in? Dr. Melissa Alsina of Moffitt Cancer Center discusses the role of clinical trials in a myeloma treatment plan at every stage of a patient’s care.

Dr. Melissa Alsina is an associate professor of medicine in the Blood and Marrow Transplant Program at Moffitt Cancer Center in Tampa, Florida where she also serves as head of the Multiple Myeloma Transplant Program. Learn more about Dr. Alsina, here.

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Myeloma Treatment & Research Updates From 2022 ASCO and EHA Meetings 


Transcript:

Katherine:

When it comes to myeloma treatment options, where do clinical trials fit in? 

Dr. Alsina:

They fit everywhere, essentially. They fit everywhere because myeloma – even though we have many, many advances, it’s a disease that we cannot cure, so there’s still a lot, a lot of work to do, so we have trials for newly diagnosed patients, improving what we do at newly diagnosed, bringing in some of those therapies, for example, like CAR-T up front, and then we have trials for early relapse/late relapse, because again, yeah, we’ve done a lot and we feel very encouraged by that, but we’re short because we have not been able to cure myeloma. 

So, it’s super important, and it’s super important that patients reach out to myeloma centers to see what is available for them because participating in a clinical trial, number one, gives a patient a unique opportunity to get something more than standard of care, something that might make their response better or their survival better.  

That’s one thing, and the other thing is the only way we’re able to move the field forward is doing clinical trials and having patients participating in clinical trials, and the reason today I can sit here and tell you that the treatment of myeloma has evolved dramatically in the last 20 years, and now we have these responses that are amazing that were unheard of, is thanks to the many patients that have participated in clinical trials. 

Without that, obviously, we would not be here with these results. But that needs to continue. I think we cannot rest because there are still patients that die from myeloma. We cannot lose the perspective that this is still an incurable disease and there’s still a lot of work to do, and the only way to get there is to continue doing the research. 

Katherine:

It sounds like clinical trials are also available for patients who have already been treated with another therapy. Is that right? 

Dr. Alsina:

Absolutely. Clinical trials are available for all the different stages of the disease – when you are newly diagnosed, when you have your first relapse, when you have your second relapse.  

Katherine:

Anytime through the process. 

Dr. Alsina:

Anytime, anytime, and there are clinical trials – the clinical trials not only help us test new drugs or new combinations of drugs, but it also helped us understand the disease better. The majority of clinical trials, we do what we call correlative studies, where we get a sample of the patient, the bone marrow of the patient, for example, before and after therapy, and we see what are the changes that we see there and what are the genes that dictate that response or lack of response. 

So, clinical trials not only help us improve outcomes in patients, but it also helps us understand the disease better that leads to other new therapies and other clinical advances. This can translate into new clinical advances 

How to Find a Clinical Trial That’s Right for You

How to Find a Clinical Trial That’s Right for You from Patient Empowerment Network on Vimeo.

If you are interested in participating in a clinical trial, where do you start? Dr. Pauline Funchain of Cleveland Clinic shares resources for patients on where to find and access a clinical trial that’s right for them.

Dr. Pauline Funchain is a medical oncologist at the Cleveland Clinic. Dr. Funchain serves as Director of the Melanoma Oncology Program, co-Director of the Comprehensive Melanoma Program, and is also Director of the Genomics Program at the Taussig Cancer Institute of the Cleveland Clinic. Learn more about Dr. Funchain, here.

Katherine Banwell:

So, if a patient is interested in joining a clinical trial, where should they start? 

Dr. Pauline Funchain:

They can start anywhere. There are many places to start. I think their oncologist is a really, really good place to start. I would say an oncologist, depending on their specialties, will have a general grasp of trials, or a really specific grasp of trials. 

I would say that the folks who have the most specific grasp on trials – what is available, what isn’t available, what’s at their center versus the next state over center – are the academic medical centers; the ones that are sort of university centers, places like the Cleveland Clinic where the docs are specialized by the type of cancer. That group of folks will have the best grasp on what’s current, what’s available. 

And so, Cindi, your friend referred you. many people do say that. Just go to whatever your nearest university center is, just because there’s a lot more specialization in that sense. But I think it’s the age of the Internet, so people can look online. Clinicaltrials.gov is a fantastic place to look. It is not as up to date, I think, as something you can get directly from a person at a medical center, but it is a great place to start.  

There are many advocacy groups and websites that will point people to trials. I mean, there are Facebook groups and things, where people will chat about trials. But I think the detail is better at a site like clinicaltrials.gov, and even better with a cancer-specific oncologist at a academic medical center.