Clinical trials at UVMCC offer cancer patients access to groundbreaking medicine—but what’s it like to be enrolled in one? Rusty Ashmore can tell you. Starting in September 2023, he was enrolled in a Phase 3 clinical trial for the drug Lomustine to treat glioblastoma. Here, he and his wife and caregiver Andrea Ashmore discuss their experience and tips—and whether they would do it again. 

Tell me about the clinical trial you were on. How did you first come across the opportunity, and why did you decide to enroll?  

Andrea: When I first started researching glioblastoma, the first recommendation that came up on every single resource was to get into a clinical trial, because glioblastoma is so aggressive and they know so little about it. 

That said, there was definitely the fear of, “If we get into a clinical trial, does that mean we won't receive the proven standard of care that everybody else is getting? Am I turning my back on what is already known to be true, to find something that is not known to be anything?” 

But in fact, all Phase III cancer clinical trials build on the standard of care.  

The type of clinical trial that Rusty was on took the standard of care, which is Temozolomide, or TMZ—a type of oral chemotherapy medication—and adds a secondary chemo type called Lomustine. Typically, people take TMZ, and if, six months down the road, they have a recurrence, they switch from TMZ to Lomustine the next time they’re treated.  

Now, Lomustine is much harsher on the body, and it’s not the go-to. The study Rusty was on looked at what the effect would be if we did both at the same time. Does it make the attack stronger? Will we see a huge difference in long-term life prognosis? We liked the proposed clinical trial because we still got the standard of care drug, plus another drug on top of it. 

Rusty is amazing in that he wants everybody to benefit from poor news. He said, “Even if it doesn't help me, maybe it'll help somebody else.” That's his personality to a T. I think that the clinical trial helped us heal and process some of the diagnosis because we knew that even if he wasn’t helped by it, there’s a piece of him that will go on to help somebody else. So, it's a way of giving back despite the terrible situation.  

Which arm were you on, and how did it go?  

Andrea: It was a blind selection, but we knew that we were on the trial arm. It was supposed to be a six-month trial that would overlap with radiation for two months. When we started the trial, Rusty had already had a craniotomy to remove the tumor. He was on steroids, and he was at his strongest at that point.  

But the two doses of chemo were so strong that we had to skip almost a month in between treatments. I was concerned because TMZ is meant to be taken once a month, and we were now taking it once every two months. In fact, we were not able to do all six rounds with the Lomustine. But it turns out that only a third of patients are able to do all six rounds because it's so harsh on the body.  

That said, we are now 20 months into this diagnosis. They gave him an 18- to 24-month prognosis, and he has not had a recurrence—so, no new growth. 

When we looked at all the MRIs after the treatment, both Dr. [Chris] Anker and Dr. [Alissa] Thomas said they couldn't believe how much radiation necrosis and swelling was present. That sounds like a bad thing, but it actually means something’s working. Normally, three months after radiation, you can do an MRI and get a pretty good idea for where things stand. And with his, it wasn't until five months after radiation that we could even get a hint because there was so much swelling and necrosis. So, I think the Lomustine did something.  

When he has recurrence or new growth, we would look at doing another clinical trial.  

And what was the clinical trial experience like?   

Andrea: Both Dr. Anker and Dr. Thomas were really good at explaining things and making us feel like we were in control and making the decision. They gave us all the information we needed, and they didn't disregard our decision not to enroll in a different clinical trial that was also available to us, but which we declined because it didn’t feel like a good fit.  

In terms of what’s expected: there’s a little more running around and doing paperwork and labs, because the team has to monitor things closely. We had to do in-person visits once a month, which meant a three-and-a-half-hour drive one way. Luckily, we were able to stay at Hope Lodge each time, and they told us results the same day as the appointment.  

Andrea, what advice would you offer caregivers who are helping a patient participate in a clinical trial?  

Andrea: Take notes! For us, when we were starting or stopping or increasing or decreasing a medication dosage, it went on the calendar. I made notes on all symptoms, good, bad, indifferent. Anything that changed—even if it wasn't necessarily something I thought was a notable event—would get written down because it could be part of the brain misfiring. I also wrote down all my questions ahead of time so I wouldn’t forget them. I mean, I have a wicked memory, but it was not good when I was dealing with the stress and the emotion of what we were going through. I’d bring these notes to every appointment so that our time there went smoothly and we had more time for questions at the end. After all, you want that 30 minutes of facetime with a doctor to be productive. There's time for emotion after those meetings; while you're there, you have to make sure you're utilizing the resources that are given to you.  

Being prepared with notes was also important for the clinical trial itself. Rusty is still part of the clinical trial even though he isn’t taking the medication anymore, and our research coordinator still comes to our appointments. They want to see what the long-term outcomes are, so he’ll be part of the trial for as long as he lives.  

What advice would you give to cancer clinical trial patients, Rusty?  

Rusty: It’s really important to be flexible, and that was hard for me at first. I've been in bad situations, had horrible days in my life, and I've never not been able to just put my head down and make it through, keep going, do what I gotta do. But the Lomustine brought my blood count so low that I couldn't take it anymore. And I had to accept that. I couldn't say, “No, I want to go through with this,” because it would've done more damage than good. I just didn't think about that when we were starting. But you really just have to have patience and grace with yourself.