Joey Wahler (Host): They're an alternative to standard treatments, so we're discussing clinical trials for brain tumor patients. Our guest is Dr. Sajeel Chowdhary. He's Director of Neuro-Oncology Translational Research with the Tampa General Hospital Cancer Institute, as well as a Professor of Neurology and Neuro-Oncology at the University of South Florida's Morsani College of Medicine.

This is Community Connect, presented by TGH. Thanks for joining us. I am Joey Wahler. Hi there, Dr. Chowdhary. Welcome.

Sajeel Chowdhary, MD, FAAN, MBBS: Thank you, Joey. Hello. How are you?

Host: Great, thanks and appreciate the time. First, how do you usually go about choosing clinical trials for a patient? How do you find a fit?

Sajeel Chowdhary, MD, FAAN, MBBS: Great question, Joey. And, uh, I always tell my patients as I had a patient in clinic just yesterday, they came with their mom, who's a bit elderly, has a, a relatively rare tumor. And they brought all their children with them, the husband and the cousins.

So it was a, a room full of very loving family. And a question came up exactly so that what would be the best clinical trial for them. And, so I always guide families that the best trial that they can pick for their loved one really is based on a few factors. Number one, of course, the tissue is to pathology what the tumor type is.

Secondly, it also depends on patient's age and their performance status that. For an example, our cancer center is in Tampa Bay, of course, and we often get patients from out of town, might be two hours away, three hours away. For instance, like the west coast of Florida goes all the way down to Naples and beyond.

And sometimes we'll get patients from that part of Florida and it's about a three hour drive to come to Tampa Bay. But patients with better performance status, if I have a clinical trial available and they can make that two hour drive every month or every two weeks to come see me. And that would also factor in the geographical location of the clinical study that would also factor in whether a patient can be a part of the trial.

So I would say that patient's tissue diagnosis, their performance status and their family's resources, how much support they have, that initially plays a big role in deciding what kind of a clinical trial would be best for them.

Host: And then what are the different types of clinical trials in neuro-oncology these days?

Sajeel Chowdhary, MD, FAAN, MBBS: Generally we sub stratify and sub classify brain tumor cancer research trials into different phases. Generally the purpose of phase one trials as a primary objective is not to see whether the drug has a significant benefit in that cancer type. Usually drugs that make it to phase one testing, they've been tested before in small single institution drug trials. So we already know there's drug activity against the tumor, but phase one trials are more toxicity data and dosing establishment. Then phase two trials are really the trials where we're testing a drug on a certain brain tumor type to see if it really works. And that's where about 80% of brain tumor trials are phase one and phase two trials.

And then there are also phase three, phase four trials. Phase four trials are few and far between. They're post-marketing studies. Phase three trials, we're comparing a new regimen to standard of care, and then the new age is now defining phase zero trials.

Because clinical trials have become so expensive that you can test a drug to kind of establish which one are the good acting drugs that have promise.

Host: Interesting. So there's even phase zero.

Sajeel Chowdhary, MD, FAAN, MBBS: That's correct.

Host: So you mentioned the term agent, clinical trial agent. Just to take a quick step back, doc, explain please if you would exactly what that is.

Sajeel Chowdhary, MD, FAAN, MBBS: A clinical trial agent,

generally in the grand scheme, it's a drug or a medication that is new, recently discovered, if you will. So most clinical trial, brain tumor trial agents are medicational drugs. Sometimes we have devices as well. Like we are more recently have been studying this radioactive seeds, CCM 131. And there's a concept of brachytherapy, which means local radiation therapy. And we're involved with two trials, two clinical trials, looking at the role of local radiation for high grade gliomas.

That's a specific type of a brain tumor and CNS metastasis. So, not always does it happen that a investigational agent is a drug, could also be a radiation device, and there are some other entities as well.

Host: So next up, drum roll please, Doctor, the million dollar question that so many wonder, and so many I'm sure ask you on a regular basis, what are the benefits of clinical trials over standard therapies, generally speaking, of course.

Sajeel Chowdhary, MD, FAAN, MBBS: Remembering a patient I met in the hospital just about a month ago, a very nice family again, who we were talking about their new brain tumor diagnosis. And the patient's wife asks me, geez, if radiation and chemotherapy, that standard is going to work and my husband is going to be okay, we can control the disease then why do we have to consider clinical trials?

And, mostly one of the best answers that I give is that we all go into the field of oncology to cure cancer and we hope one day we will completely cure cancer. And so in pursuit of that journey, as investigators and researchers and clinician scientists, we're always developing clinical trials, research so many a times where majority of our trials are not placebo trials.

Patients get standard of care plus drug X and plus drug Y, for instance. So it's like you get your cake and you can eat it too, that you can get standard of care therapy plus another agent added to it that might give that extra oomph and that extra push that maybe will reach that promised land of curing that disease for that patient. And the family understood that philosophy and they agreed to consider, that certain clinical trial.

Host: So oftentimes a clinical trial isn't so much something, instead of a standard treatment as much as an additive, right? A supplement.

Sajeel Chowdhary, MD, FAAN, MBBS: Precisely.

Host: Couple of other things before we let you go. It's interesting you mentioned earlier Doctor sitting in a room full of loved ones of a brain tumor patient and laying it out for all of them. And it brings up a great point, I think, which is that typically when these diagnoses occur, it affects an entire family for a variety of reasons.

And because of that, I wonder, what's it like for you when you're laying things out, not just for the patient, but for their kids, their parents, who knows, whoever else might be attached and involved. What's that like for you? Because you know that so much is hanging in the balance, so to speak.

Sajeel Chowdhary, MD, FAAN, MBBS: Great question, Joey, and that might actually be the hundred million dollar question. I'm very blessed. Our local university produces excellent medical students and every week I have, uh, one of them with me during their third year of medical college and I always want to teach them that yes, treating disease is important and the patient, but to be a better doctor, you have to treat the whole family, and especially in the world of cancer, where it really becomes a family of affair. It's a life changing experience. So as a good doctor, as a good cancer doctor, if you haven't touched the lives of the husband, who's going to be the caregiver now of the wife, of the son and daughter who are, were away in college, in far away states and cities that will now have to visit more often to come help with their mom and the sister that was always reliant on the patient, but now needs to be the caregiver instead. So you almost have to have eight conversations with all the other seven family members in a room, not just the patient.

And you almost have to form that connection as an oncologist with not only the patient, but almost equally as importantly, to their kids, their siblings, their loved ones, and then maintain that relationship. And you have to support them as well, because that's the whole unit, by just caring for the patient that will not be enough. And if you care for the family, they will help the good doctors carry the patient through this very difficult journey.

Host: To follow up on that, in summary here, Doctor. What's it like, basically trying to balance providing hope for patients, which is obviously a key part of what you're doing here, while at the same time, keeping things realistic in terms of expectations. Is that a fine line sometimes?

Sajeel Chowdhary, MD, FAAN, MBBS: Yes, Joey. Very, very, crucial question there. As cancer doctors and clinician scientists, we have to be the ever optimist and go to work every day having hope ourselves to have the spirit to give our patients everything they need that day, because we have that hope at the end of the tunnel that we can fix this one day and we can cure this.

And, the last thing good doctors want is, is to lose their patients to a disease. But on the same token, we have to be realistic. If the median survival of a certain cancer is two to three years; it's almost a bit of an art. That's where they say the art of oncology is just as critical as the science is and as much as we have to give the realisms, but we have to find a way delicately. And as you said, Joey, very well spoken. It's a fine line that we also have to give them hope that everybody's individualized. Their cancer genetics are different, the way they will respond to radiation and chemotherapy and clinical trial drug agents can be different. But I agree with you. One has to be realistic and very upfront, but also find a way that we can infuse optimism because I believe hope directly equates to our patients having the spirit to fight. And that's the wind beneath their sails. Uh, so we cannot take away that either.

Host: Very well said indeed. Well, folks, we trust you are now more familiar with clinical trials for brain tumor patients. Dr. Chowdhary, keep up all your great work. It's certainly groundbreaking work and as you just explained, so very well, one that involves, as you put it, more than just science, the art, as you said, of the oncology work that you do, providing that human touch and, a pleasure and thanks so much again.

Sajeel Chowdhary, MD, FAAN, MBBS: Thank you, Joey. Appreciate it.

Host: And for more information, please do visit tgh.org/cancer. Now, if you enjoyed this episode, please be sure to like, subscribe and follow Community Connect presented by TGH on your favorite podcast platform, and share it on your social media as well. I'm Joey Wahler, and thanks again for being part of Community Connect presented by TGH.