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Advancing Hope: Clinical Trials in Pediatric Cancer · Pediatrics in Practice: A CME Podcast

• 0:01
  Mike (Host): This is Pediatrics in Practice, A CME podcast.
• 0:05
  I'm Dr.
• 0:06
  Mike, and with me is Dr.
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  Kevin Gin from Children's Mercy, and today we are discussing advancing Hope,
• 0:13
  clinical trials and pediatric cancer.
• 0:15
  Dr.
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  Gin, thank you so much for sharing your time with me today.
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  You why are clinical trials so critical in advancing pediatric cancer treatment,
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  say compared to adult oncology?
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  Kevin Ginn, MD: Yeah, good morning.
• 0:28
  Yeah, it is really the same principle.
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  So we need advancements in cancer in general, whether it's adult or kids.
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  We have different challenges, of course, with pediatric cancers, primarily
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  because they're more rare, than adults.
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  So we have more difficulty running those clinical trials to make those
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  advancements because numbers of patient's we need are not necessarily there.
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  The tumor types are different in pediatrics.
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  Compared to adults as well.
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  So, we used to try to bring down clinical targets from adult trials and,
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  try those in children and they didn't always work as well and it was because
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  the cancers are different And we learned that over time, we have the need to,
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  find new therapies because we are.
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  Quickly reaching, kind of maximum tolerated therapy so kids are able
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  to tolerate chemotherapy better than adults in a lot of cases.
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  But we are really beating these children up with a lot of, radiation,
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  surgery and chemotherapy and, And we need better treatments to reduce that
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  toxicity and, and improve survival.
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  'cause in some instances we're not improving survival even though
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  we are being a very aggressive.
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  Mike (Host): What do you say to some parents maybe who have already
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  enrolled their child in a clinical trial, but it's still in the recruiting
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  phase, it's taking a little longer.
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  how do you explain that, to them And that, that it's important to
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  get the right amount of patient's?
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  Kevin Ginn, MD: Yeah, I mean that comes, comes into play most commonly
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  when parents are waiting on the opportunity to enroll in a trial.
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  'cause I run earlier phase clinical trials, so the safety.
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  It is so important on those trials with these drugs that haven't been tried in
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  patient's as often, and we're trying to learn safe doses and side effect profiles.
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  So trying to explain to a family that the treatment that they think may be, best
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  for their child may not be available to them at the time they need it because of,
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  of it being closed for safety monitoring.
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  So trying to explain that aspect of it.
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  A lot of families.
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  I think that we can get these drugs outside of the trials And we're
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  not always able to, depending on what stage they are in development.
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  Mike (Host): What are the biggest barriers for families?
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  what do they face when considering enrollment in a, cancer clinical trial?
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  Kevin Ginn, MD: I just mentioned availability.
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  So families are savvy these days and, do their own research online or talk
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  to other family members even other patient's through like connections
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  through social media and connect with other families of the same tumor types.
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  So they hear about these trials at other centers or at our center.
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  so they want the availability of those either locally And we definitely try
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  to do that here at Children's Mercy.
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  getting lots of options for patient's.
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  But still, there's kids that have to travel either to other sites or
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  to our site from a long distance.
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  So the travel And the cost associated with that, because it's not always.
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  covered to support their meals or gas and those sorts of things.
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  Even though we do have some resources, clinical trials have more restrictions
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  on time points, so we don't have the flexibility to say that, yeah,
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  you can come in a couple of days.
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  We really need that time point to be on time for that clinical trial.
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  There's much more strict criteria.
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  Sometimes they have longer time at the hospital, so, spending longer time because
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  we need drug monitoring levels like a.
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  PK levels that have like all day blood draws that they have
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  to hang around the hospital.
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  And then just the burden of navigating options.
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  So there are a lot of options often for a patient and trying to figure out what
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  is the best treatment for that particular patient And what the family understands
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  about those options is, it's hard for families and it's hard for us too,
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  especially when not one clinical trial treatment is necessarily better than
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  the other 'cause we just don't know yet.
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  But trying to figure out what's best.
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  Mike (Host): communication obviously is, so important here.
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  how do you communicate the risks and benefits of trial participation to
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  parents And in ways that build trust?
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  Kevin Ginn, MD: risk is definitely important, especially in these early
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  phase trials, as I mentioned, that have drugs that most of the time in
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  pediatrics have at least had some.
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  Study in, an adult population or previous clinical trials, but there
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  may be drugs that are pretty new and, And we don't know a lot about them,
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  so there's potentially a huge risk.
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  so the fa parents get sort of frustrated with us for not having
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  all of the information, but we are able to at least go through
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  what we know, what the risks are.
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  I try to go through.
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  The known and previous risks and, point out to them which ones I
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  think as a medical provider are most concerning and most risky.
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  The consent forms that are generated include tables that list
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  out what we know about risk and is divided up into less likely.
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  Most likely and least likely.
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  But if you look at those tables, it's overwhelming.
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  There's, hundreds of things listed and not a lot of them make sense to families.
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  And sometimes the things that are least likely to occur can be the scariest thing,
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  and you don't want that for your child.
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  so we discuss, I could discuss the, what we're worried about.
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  What our monitoring plan is gonna be And the safety plans that are built into
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  the protocol and let them understand that, that we know these things need
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  to be monitored, but, but we, need to still, monitor very closely for
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  some unknown side effect profile.
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  So families do take that into consideration.
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  What is the risk?
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  Something like an immunotherapy that might result in significant inflammation
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  and hospital stays that are prolonged or ICU stays versus a, a pill that
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  they take by mouth every day that has lower side effect profile is, appealing
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  to them, especially if we don't know that one's better than the other.
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  Mike (Host): speaking of immunotherapy, how has recent innovations like
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  immunotherapy, precision medicine, how have they changed the design and.
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  Kevin Ginn, MD: the most common ways that I've seen that affect our clinical
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  trials is we are dividing patient's up into smaller and smaller baskets.
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  So, We know a lot more about specific tumor types And we know more about certain
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  targets, but if we have a rare population of patient's of a certain tumor And
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  then we divide that even further by a certain target that's only available in
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  say, 10% of patient's And we have a drug for that, then it's hard to run those
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  clinical trials so there's improved.
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  Kind of nationwide and even worldwide collaboration to try to capture as
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  many of those patient's as possible.
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  and if you miss the one kid that comes in once a year with that tumor type
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  because of availability at the time or some other reason, then you're missing
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  a huge opportunity to learn about it.
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  immunotherapies are a different beast.
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  You know, they have timing restrictions for something like CAR T cell
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  therapies that have to be generated.
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  So I've had patient's that qualified for CAR T cells, yet.
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  The timing of slot availability and ability to generate for that next patient.
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  just the logistics of it can be challenging.
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  And then, as I mentioned, the, the monitoring required for some of
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  those therapies And the, more serious inflammation and, side effect profiles
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  of some of those therapies can be problematic and require prolonged stay.
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  Mike (Host): it seems like as we get more, personalized with our cancer
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  diagnoses and treatments that it is.
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  Is gonna take a global effort then to kind of gather all that
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  data up to make decisions, right?
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  Kevin Ginn, MD: That's right.
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  recently we have a clinical trial we're participating in currently
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  because it's a global trial.
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  They, they're having safety meetings weekly, but because of
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  the, global nature of it, they have to have two a day now because the.
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  The time zone differences they're having one that occurs our time at like 6:00 AM
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  that I'm not attending, but the 3:00 PM afternoon one for the rest of the world.
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  is more appealing of course for me.
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  Yeah.
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  Mike (Host): Yeah, that's interesting.
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  and I'm sure that's gonna be an exciting area that we'll see how, cancer
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  trials grow And in change in design.
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  Um, I gotta ask Dr again.
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  Everybody's talking about it, asking about it.
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  How is AI affecting this?
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  Or is it.
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  Kevin Ginn, MD: I personally haven't seen it.
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  affecting anything here yet?
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  at least at Children's Mercy.
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  I know there, there are, a lot of interest in AI technologies and,
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  primarily the interest that I have in it has been with diagnostics so.
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  Earlier identification of a relapse or better assessment of
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  staging or, response to treatment.
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  So using, computerized AI technology to assess.
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  A scan and instead of having a human eye look at the pictures on
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  the screen, the, computer generate.
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  What is different about this scan compared to the last three scans and
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  being able to pick up on those minute details that might, be missed by someone?
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  So, few years ago, there was a great presentation at a national meeting where
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  they were using such technology and say adult mammograms and being able to.
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  Utilize that technology to pick up on minute breast cancer, that was
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  missed potentially by the radiologist.
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  Mike (Host): How do you ensure families have adequate support
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  throughout all this and resources, during the clinical trial process?
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  Kevin Ginn, MD: children's Mercy, it has excellent resources from a, nursing
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  support staff that are well-trained and certified And in pediatric oncology.
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  we have social work, that can help with logistics of housing.
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  Things like FMLA and time off from work and other community organizations
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  that want to help families and help contribute to, covering some of the
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  costs that, families are incurring.
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  we of course have great physician staff with multi specialty
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  services that are able to, handle, anything that comes our way.
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  but I.
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  I think pediatricians also play a great role in that, especially
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  for those patient's that live some distance away from the hospital.
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  Because we may not always be able to allow a study physical or study labs to
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  be done at an outside facility 'cause there may be restrictions on that.
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  But if I have a kid on an experimental treatment and they live four hours away
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  and there's some something they're calling me with concerned about, then I need.
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  Someone to help me assess that patient, and that's a great thing
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  that the, the local pediatrician can help assess and, and communicate that
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  medical assessment back to us as we determine what's best for that kid.
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  Mike (Host): Looking ahead, what do you see as the most promising
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  areas of research in pediatric oncology clinical trials?
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  Kevin Ginn, MD: I mean, you've already mentioned precision
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  medicine and immunotherapy.
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  I think Those are continuing to be very important.
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  Targets for improvement.
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  just in my career, my, other primary specialty is brain tumors And in the
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  last five or six years, we've seen four or five FDA approved therapies
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  that are, really previously unheard of for brain tumors in pediatrics.
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  And it's based on those specific targets that were identified
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  that we found drugs for.
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  And in doing the clinical trials and finding that there was
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  improvement compared to chemotherapy.
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  And then also interesting is, is something that you may not think about
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  all the time is reduction in therapy.
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  So as we divide these tumors into a.
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  Groups of patient's and can analyze these small subsets.
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  We find ones that aren't doing well with current therapy that need
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  better options, And we of course, are gonna focus on those patient's.
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  But we're also finding patient's that are doing really, really
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  well with current therapy.
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  But are current therapies very toxic?
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  So clinical trials are also trying to reduce treatment.
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  That's a hard sell sometimes to families though, to tell them.
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  Your kid has a really good chance of doing well with current therapy,
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  but it's very toxic, so we wanna reduce it and see what happens.
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  'cause that of course could lead to, a relapse for that patient.
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  Mike (Host): That's a tough one.
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  That on them, isn't it?
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  So, it'll be interesting to see how you guys navigate,
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  through that over the years.
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  doctor, again, this has been fantastic.
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  Thank you for coming on today.
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  Kevin Ginn, MD: Thanks for having me.
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  Mike (Host): For more information, you can go to C mkc.link.
• 12:35
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• 12:41
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• 12:47
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• 12:47
  Mike.
• 12:48
  Thanks for listening.