CNS-201 Berubicin vs SOC Lomustine in Recurrent GBM (Glioblastoma)

What is the Purpose of this Study?

This study is divided into three periods: the screening period, the study drug period, and the follow-up period.

The screening period lasts about 28 days and includes:
- Physical exams
- Blood draws and a urine sample
- Imaging scans (MRI)
- An electrocardiogram (ECG) and echocardiogram (ECHO)

If we find that you are eligible to join during the screening period, you will proceed to the study drug period. During this period of the study, you will get a random assignment (like flipping a coin) to get the study drug intravenously (IV) through a vein in your arm every 3 weeks (1 cycle) or to get lomustine, which you will take by mouth once every 42 days (1 cycle). A computer will make these assignments in a 2:1 ratio, which means you will have a 67% (2 out of 3) chance of being assigned to receive the study drug, and a 33% (1 out of 3) chance of being assigned to receive lomustine.

You may need to visit the study clinic up to 3 times within 3 weeks (if you complete 1 cycle with berubicin) or 7 times within 6 weeks (if you complete 1 cycle with lomustine).

Each additional cycle will require you to come to the study clinic for further visits. At each visit you may:
- Have physical exams
- Have blood draws and give urine samples
- Have imaging scans (MRI)
- Have electrocardiograms (ECG) and echocardiograms (ECHO)
- Answer questionnaires

You will stay on your assigned study regimen as long as you and your doctor believe that you are benefitting from it. The regimen will stop if your disease progresses, you experience side effects that are intolerable, or you and/or your doctor decides to stop the study drug regimen for any other reason.

About 28 days after you finish your study regimen, you will have a follow-up visit to see how you are doing. At this visit you will:
- Have a physical exam
- Have a blood draw and give a urine sample
- Have an imaging scan (MRI)
- Have an electrocardiogram (ECG) and echocardiogram (ECHO)
- Answer questionnaires

About every 6 months after that visit, someone from the study team will contact you to see how you are doing and ask about any other treatment you have had for your brain tumor.
What is the Condition Being Studied?
Glioblastoma Multiforme (GBM) that has come back after initial therapy

Who Can Participate in this Study?

Adults ages 18+ who:

- Are diagnosed with recurrent or progressive GBM

- Have not received more than 1 line of previous treatment

- Have not received previous treatment with either bevacizumab or lomustine

- Do not have unstable angina, uncontrolled arrhythmia, or a history of heart attack within the past year

For more information about who can join this study, please contact the study team at 919-684-5301.

Age Group
Participating Institutions

What is Involved?

We are doing this study to find out if an investigational drug called berubicin (the study drug) is an effective option for patients with GBM that has recurred (come back) after initial standard therapy. We will compare how well it works to treatment with lomustine, which is an FDA-approved drug for GBM. Both the study drug and lomustine are designed to slow or stop the growth of cancer cells.

Study Details

Full Title
A Multicenter, Open-Label Study with a Randomized Control Arm of the Efficacy, Safety, and Pharmacokinetics of Intravenously Infused Berubicin in Adult Patients with Recurrent Glioblastoma Multiforme (WHO Grade IV) After Failure of Standard First Line Therapy (CNS-201)
Principal Investigator

Protocol Number

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