Clinical Trial to Offer Insight Into Newly Diagnosed Patients With Glioblastoma

Glioblastomas are difficult to treat, but researchers are hopeful that clinical trials will lead to new developments.
One of the greatest ways to learn more about a specific tumor type and to see which drugs have positive responses in patients is through clinical trials. This is especially important in the treatment of glioblastoma (GBM) — a fast-growing, brain tumor that has a low five-year survival rate.
Brian Alexander, M.D., M.P.H., disease center leader for radiation oncology in the Center for Neuro-Oncology at the Dana-Farber Cancer Institute in Boston, is recruiting newly diagnosed patients with GBM for a clinical trial called the INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT).
He and colleagues will be testing three different kinds of therapies — abemaciclib, neratinib and CC115 — at the same time, and testing them against the control arm, which will be receiving Temodar (temozolomide) and radiation therapy.
In an interview with CURE, Alexander discussed the hypothesis of the trial, biomarkers for evaluating patients and what he’s excited about for the future of GBM.

What do you anticipate to happen in the INSIGhT trial?

Our hypothesis is that one of these drugs will improve survival for patients with glioblastoma. The way that we do clinical studies is to first see if something looks promising in the lab, then see if it looks safe in patients and finally test to see whether it looks like it’s doing anything that a patient would consider important like improving their life or extending their life.
For glioblastoma trials, it is really tricky to understand whether a drug is working if you just run a trial with one experimental arm and no comparison. We have been fooled before in this disease where something looks good, but it’s only because we are selecting the right patients.
So, this is a randomized trial. Patients hear that a lot and don’t like that because they want to go on an experimental therapy. That’s why they are going on a trial. We have tried to have a compromise here where we have a platform trial and we are using one control arm to test really three different therapies at the same time. We’re conserving that control arm, which makes it more likely that a patient is randomized to an experimental therapy.

Are there certain biomarkers that can be evaluated for GBM?

The biomarkers that we are interested in are the ones that predict the patients that are going to respond to any given therapy. We don’t know very much actually in this tumor. We know a lot about the biology of the tumor. We know a lot about the molecular abnormalities of the tumor, but we don’t know how much those molecular abnormalities mean in terms of predicting response to any therapy.
But, what we have set up in this trial is a system by which that data will be generated and used during the course of the trial, so we do sequencing on the tumors to get the most up to date genetics that we can. Instead of just guessing what those genetics mean, we try to learn about them during the trial. We set up that system within the trial to learn what those specific biomarkers mean.

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