Derek Hanson, MD, Director of Pediatric Neuro-oncology at Joseph M. Sanzari Children’s Hospital, talks about the Optune helmet and how it can help glioblastomas in children.
Could you tell us more about glioblastoma?
HANSON: Glioblastoma is a very aggressive form of brain tumor. It’s something that we see commonly in adult patients, but in the pediatric population, it’s rare. Unfortunately, there are not many good treatments for glioblastoma. In the adult population, the outcomes are very poor. And we see the same thing in pediatrics. It’s a very difficult tumor to treat. Typically, the treatment for glioblastoma would be to go for a surgical resection up front and try to remove as much of the tumor as possible. Sometimes these tumors can’t be easily removed because they’re so aggressive and they’ve spread throughout the brain. But ideally, we’d like to go in and get a surgical removal of the tumor. After that, the standard therapy is usually radiation treatment. We really don’t have good therapies for glioblastoma. After surgery and radiation, we’re pretty much left with experimental treatments because we know the standard treatments for other brain tumors aren’t very effective. So, it’s important, especially in pediatrics, to be able to offer clinical trials and new therapies for patients because we know if we just stick with radiation and surgery, the outcomes are extremely poor.
Can you give me an idea of how rare it is in kids?
HANSON: It is extremely rare in children. These high-grade gliomas, or glioblastoma, are probably somewhere in the five to 10% range of all the brain tumors that we treat in children. However, these glioblastomas are very aggressive and account for a large portion of the poor outcomes that we see in pediatric patients.
Is there a particular section of the brain where the glioblastoma starts?
HANSON: Glioblastomas can really occur anywhere in the brain. They arise from glial cells, which are throughout the brain and the spinal cord. So, they can arise in any location.
What are the extra challenges present when you’re trying to resect the glioblastoma?
HANSON: Brain surgery, particularly brain surgery in a child, is extremely challenging. Unlike other parts of the body where we try to get out a wide margin to make sure that we’ve captured all the cancer cells. You really can’t do that in the brain because it’s such an important part of the body. You really can’t take out extra brain tissue to try to get a wide margin around the tumor. It takes a highly specialized pediatric neurosurgeon to go in and remove it safely without injuring the child. Unfortunately, because glioblastoma is so aggressive and tends to be very infiltrated, the tumor cells extend beyond that tumor. Even having a surgeon go in and doing what we call a complete removal or resection, where we look at the MRI scan and don’t see any tumor remaining on the scan, we know that there’s extension beyond that primary tumor that the cells have infiltrated out into the brain tissue surrounding the tumor. So, even a complete resection isn’t a full resection. There are always tumor cells left behind with glioblastoma.
Can you talk to me a little bit about Optune? What is it and what it’s designed to do?
HANSON: Optune is a very new, promising therapy for brain tumors. It’s been tested extensively in adults with glioblastoma and has shown very promising results. But it has not been tested extensively in the pediatric population. I knew about Optune from my adult colleagues and had seen the good results in adult patients. But there really wasn’t much that had been done yet for pediatrics. So, I reached out to the company and asked if they’d be interested in a trial. Optune is a very innovative therapy. It’s not your typical treatment that we use for brain tumors. It’s not radiation. It’s not chemotherapy. It’s a device that gets worn on the head. There are four leads that are placed on the scalp, one in the front, one in the back, and then one on each side. These four leads send electric signals called tumor treating fields into the brain directed at the tumor. These electric fields disrupt mitosis, or cell division. For tumor and tumor cells to grow, they need to divide and multiply. There’s something called the mitotic spindle, which is where all the chromosomes line up so that the cell can then split in two and make a copy of itself. When that mitotic spindle is being formed, it’s what we call a polar process, with positive and negative charges. These electric signals that are sent from Optune into the tumor disrupt that whole process. And that leads to cancer cell death. So, it’s a very innovative therapy because it’s not using radiation or chemo. It’s a device. These electric signals that are sent into the brain aren’t something that the patient feels. It’s not something that causes a lot of side effects. It’s a really great therapy from the standpoint that it’s something very well tolerated by patients and doesn’t cause a lot of side effects. So, the thought was, can we take this new promising therapy that is a device that doesn’t have a lot of systemic side effects and potentially combine that with chemotherapy because there’s no overlapping side effects between the two treatments. We can already use the chemo that we’ve been using in the clinic and add Optune into the equation because the side effects are overlapping. Perhaps we can treat with chemotherapy and with Optune to have better results for patients.
Does the cancer have to be at a certain stage? Or is it for any stage?
HANSON: Right now, with the trial, it’s open for any stage. It can be for patients who are newly diagnosed and have just completed their surgery and radiation. We also have the option for patients who have glioblastoma that has recurred to go in therapy on the clinical trial. Ideally, we’d like to treat patients right after surgery and radiation where the tumor has been completely removed, at least on the MRI scan, because we feel those are the patients who have the least amount of disease and have a potentially less aggressive form of glioblastoma.
How is the Optune delivered? Is the patient lying down or are they in a machine?
HANSON: Optune is something that’s worn every day by the patient. There are four leads which look like large EKG leads, which is adhesive pads that get placed on the scalp. One on the front, one on the back, and one on each side. They’re connected to a power source, which is a small battery pack, that powers the leads and sends the electric signals into the tumor. It’s lightweight, weighing only about two pounds. It’s something that patients can carry around with them as they go through their day-to-day treatments. Patients need to be treated for at least 18 hours per day, every day, on this treatment. So, it’s something that they’re wearing as they are going about their daily activities, and something that they have on at home. Thankfully, there isn’t any pain associated with it. It’s something that patients get used to wearing on their head, but it is something that is a daily commitment to be wearing this with the device powered on for 18 hours a day.
Can we talk a little bit about Ivan? He’s wearing the Optune. How is that working for him?
HANSON: Ivan has done extremely well with treatment. When we first met him, it was before his initial surgery. We found the mass on the MRI scan and came up with a plan with his neurosurgeon to have the tumor removed. Thankfully, he was able to have the tumor completely removed, at least as far as we can see on the MRI scan. He then went for six weeks of radiation treatment and then enrolled on the trial with the Optune combined with chemotherapy. He’s had a fantastic outcome so far. It’s been great to see how well he’s done. The clinical trial is planned for 12 cycles of treatment, which is about a year of therapy. He’s made it through those 12 cycles and completed the actual study portion of the clinical trial. But because he’s had such great results and is doing well and feeling well, he’s opted to continue treatment. So now we’re coming up on almost two years since his diagnosis, which is fantastic. He just recently had an MRI scan, which was clean. It didn’t show any further evidence of tumor. It’s been an amazing story. And he’s had an incredible journey through this process. Unfortunately, glioblastoma has a very poor prognosis. Most patients, even with surgery and radiation, will relapse typically within six to 12 months after that diagnosis.
How long can Ivan continue that treatment? Is there a time where it won’t be effective or more of a risk for him to continue to do this?
HANSON: One of the tricky things with Optune is figuring out when to stop treatment. Obviously, if we found out that the treatment wasn’t working, we would need to switch to something else. But in patients who are having a great response, like Ivan, it really becomes a question of when do we stop treatment? There is the quality of life aspect and having to wear the device on your head. Most patients would obviously prefer to not have to do that. But when you have such a high-risk tumor and you’re seeing a great response, obviously the debate comes, do I just continue going with this because it’s not causing any side effects? It’s a personal decision for each patient when they feel like it’s time to move on and potentially try to stop therapy and hope that the tumor stays away. But many patients will continue it for years if they’re having a good response.
How many patients do you want to enroll at Hackensack and over what period of time?
HANSON: Right now, the trial is set up as a pilot study of six pediatric patients. Currently, we’ve had four patients enrolled in the study, two here at Hackensack and then two at our secondary site, which is Arnold Palmer Children’s Hospital in Orlando, Florida. The goal is to test six patients just to see what the safety is of the device, even though we feel it’s likely going to be well tolerated, as well as to look for effectiveness. Once we get through this initial pilot phase with the six patients, we’re in talks with the company to potentially expand this to a larger Phase two clinical trial, which will likely involve multiple children’s hospitals, all partnering with us to test this in as many patients as possible.
Do you have an adult trial also here at Hackensack?
HANSON: The adults have been working with Novocure, who has produced the device for many years. They’re involved in the initial adult trials that led to its FDA approval.
Are there any patients for whom this isn’t recommended at all?
HANSON: The device only works for tumors on the top of the brain. So, if you had a tumor that was outside the field where the device could reach, then this wouldn’t be a good option for them.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Mary McGeever, Hackensack University Medical PR
Sign up for a free weekly e-mail on Medical Breakthroughs called First to Know by clicking here
