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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
IRCCS Humanitas Research Hospital	Rozzano	Italy

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Itfkeyvw Rjdedeio Dv Cbrzjz Dg Mbtxidgexny	Montpellier	France
Izkhivyv Costox Dinsbkydhndsndyuk	L'hospitalet De Llobregat	Spain
Awieyodggm Pxjlxzzq Hzaxiand Do Mteekgfni	Marseille	France
Hkzxklas Uutsxxlijzkfm Hgfvlyge Tdqpr y Pxjwoo Igixvoom Cmnbjd dhtzjmlxybiicvawy (ucpt	Badalona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.07.2021
Italy	Not recruiting	01.07.2021
Spain	Not recruiting	01.07.2021

Trial locations

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.

Investigated diseases:

Glioblastoma multiforme

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 ID:

2024-517660-27-00

Protocol code:

CNS-201

NCT ID:

NCT04762069

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?