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Study of Berubicin versus Lomustine in adult patients with recurrent Glioblastoma Multiforme after first-line treatment failure

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on adults with Glioblastoma Multiforme, an aggressive type of brain tumor that has returned or gotten worse after initial treatment. The study will test a new medication called Berubicin, which is given through an intravenous infusion, comparing it to Lomustine, which is taken as an oral capsule.

The purpose of this research is to evaluate how well Berubicin works compared to Lomustine in extending survival time for patients whose brain tumor has come back after their first treatment. During the study, patients will receive either Berubicin through an infusion into their veins or Lomustine taken by mouth. The study is open-label, which means both doctors and patients will know which treatment is being given.

The study will track several important measurements including how long patients survive, how long it takes for the tumor to grow, and whether the tumor shrinks in response to treatment. Doctors will use MRI scans to monitor changes in the tumor throughout the study. The effectiveness of the treatment will be determined by comparing survival times between patients receiving Berubicin and those receiving Lomustine.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial eligibility confirmation

    Your medical records will be reviewed to confirm glioblastoma multiforme (GBM) diagnosis and verify that you have received no more than one prior line of treatment

    A brain MRI scan will be performed to document disease progression

    Basic laboratory tests will check your blood counts, liver, and kidney function

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either Berubicin or Lomustine

    If assigned to Berubicin, you will receive it through an intravenous infusion

    If assigned to Lomustine, you will take it as oral capsules

  3. Step 3

    Treatment period

    Regular brain MRI scans will be performed to monitor your response to treatment

    Blood tests will be conducted to monitor your health during treatment

    Your doctor will assess any side effects you may experience

  4. Step 4

    Follow-up monitoring

    After completing treatment, you will continue to have regular check-ups

    Brain MRI scans will be performed to monitor disease status

    The study will continue until January 2026

  5. Step 5

    Important requirements

    You must maintain effective birth control during the study and for several months after treatment completion

    Regular attendance at scheduled appointments is necessary

    Report any new symptoms or side effects to your doctor promptly

Who can join the trial?

15 criteria

  • Must provide written informed consent and be willing to follow study procedures
  • Must be at least 18 years old
  • Must have a Karnofsky Performance Score (KPS) of 60 or higher (this measures ability to perform daily activities)
  • Must have confirmed diagnosis of Glioblastoma multiforme (GBM) based on tissue examination
  • Must have received no more than one previous line of treatment
  • Must have recovered from side effects of previous treatments to mild level or less
  • Must be on stable or decreasing dose of steroids for at least 5 days before brain MRI
  • Must have adequate blood cell counts, liver function, and kidney function, including:
    • White blood cell count ≥ 3,000 per microliter
    • Platelet count ≥ 75,000 per microliter
    • Hemoglobin ≥ 10 grams per deciliter
    • Women who can become pregnant must:
      • Have negative pregnancy test
      • Use effective birth control during study and for 6.25 months after
      • Men must use effective birth control during study and for 3.5 months after
      • Must be free of other cancers for at least 5 years (except for successfully treated skin cancer or cervical cancer in situ)
      • Tumor must be located in the upper part of the brain with no spread to the spine or brain fluid

Who cannot join the trial?

15 criteria

  • Prior exposure to berubicin or other similar chemotherapy drugs in the same class
  • Active untreated brain metastases (cancer that has spread to the brain from other parts of the body)
  • Severe heart problems or uncontrolled high blood pressure
  • Significant liver or kidney dysfunction
  • History of other cancers within the past 5 years (except for successfully treated non-melanoma skin cancer)
  • Pregnancy or breastfeeding
  • Active serious infections requiring treatment
  • Major surgery within 4 weeks before starting the study
  • Participation in another clinical trial within 30 days before this study
  • Known allergies to the study medications or their components
  • Inability to swallow oral medications
  • Severe psychiatric conditions that could interfere with study participation
  • Life expectancy less than 3 months
  • Immunocompromised status (weakened immune system)
  • Use of certain medications that might interact with the study drug
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Investigated drugs

  • Berubicin

    is a chemotherapy medication given through an intravenous infusion (directly into the vein). It is being studied for treating adults who have a type of brain cancer called glioblastoma multiforme that has returned after initial treatment. This medication works by attacking cancer cells to stop them from growing and spreading.

  • Lomustine

    is an oral chemotherapy medication that is currently used to treat brain tumors. It belongs to a group of drugs called alkylating agents, which work by damaging the DNA of cancer cells to prevent them from multiplying. In this study, it serves as a comparison treatment to evaluate the effectiveness of Berubicin.

What is already known about the treatment

  • Berubicin

    An investigational chemotherapy drug administered through intravenous infusion, specifically being studied for the treatment of recurrent glioblastoma multiforme (an aggressive type of brain cancer). This drug belongs to the anthracycline class of medications and works by interfering with DNA synthesis in cancer cells to prevent their growth and multiplication. Currently undergoing clinical trials to evaluate its efficacy compared to existing treatments, Berubicin is being investigated as a potential treatment option for patients whose brain cancer has returned after standard first-line therapy.

  • Lomustine

    An established chemotherapy medication taken orally that belongs to the nitrosourea family of drugs, commonly used as a treatment for various types of brain tumors, including recurrent glioblastoma. The drug works by damaging the DNA of cancer cells, preventing them from dividing and growing, and is often used when initial cancer treatments have not been successful. Lomustine serves as a standard comparative treatment in clinical trials due to its established history in treating brain cancers.

Investigated diseases

Glioblastoma multiforme - A rare and aggressive type of brain cancer that develops from glial cells in the brain. It forms in the supportive tissue of the brain and can grow rapidly, creating pressure within the brain. The tumor typically appears in the cerebral hemispheres but can develop in any area of the brain. Glioblastoma multiforme can infiltrate and spread through brain tissue, making it particularly complex. The condition often causes symptoms such as headaches, nausea, vomiting, and neurological changes depending on the tumor's location in the brain.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517660-27-00Protocol codeCNS-201Estimated enrolment328 patientsSponsorCns Pharmaceuticals Inc.

sourced from the EU Clinical Trials Register and site verification

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