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Anthracenedione

Berubicin for Glioblastoma

Phase 2
Waitlist Available
Research Sponsored by CNS Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The tumor is localized supratentorially with no leptomeningeal (local or distant), spinal or CSF metastases, and no ventricular invasion (explicit documentation of the disease progression that would be problematic in evaluating the efficacy of this drug).
Recurrent or progressive GBM as evaluated by central review applying RANO criteria on contrast MRI scans of the Baseline/Screening MRI scan obtained up to six weeks prior to C1D1 and a historical scan taken before the Baseline/Screening scan that meets at least 1 of the following criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 4 years.
Awards & highlights

Study Summary

This trial will compare the effect of two cancer drugs, berubicin and lomustine, on overall survival in patients with glioblastoma multiforme (GBM) who have failed standard first line therapy. A futility analysis will be performed after approximately 30-50% of planned patients have completed the primary endpoint at 6 months.

Who is the study for?
Adults with recurrent Glioblastoma Multiforme (GBM) who've had standard treatment can join. They must have recovered from previous treatments, be eligible for chemotherapy, and not have used certain drugs like bevacizumab or lomustine before. Women of childbearing age need to use contraception.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of Berubicin versus Lomustine in treating GBM after first-line therapy fails. Patients are randomly assigned to either drug in a 2:1 ratio, focusing on overall survival rates and response to treatment.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally may include typical chemotherapy-related issues such as nausea, fatigue, blood cell count changes, increased risk of infection, hair loss, and potential organ toxicity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My brain tumor has not spread to the spinal cord, brain linings, or ventricles.
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My brain tumor has grown or returned, confirmed by recent MRI scans.
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I can care for myself but may need occasional help.
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My diagnosis of GBM is confirmed by a pathology report from a biopsy or surgery.
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My cancer's MGMT methylation status is known.
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I am 18 years old or older.
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I've had only one treatment course for my condition, or used TTFields as my first treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 4 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion an average of 4 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival
Secondary outcome measures
Event Free Survival
Overall Response Rate
Plasma Pharmacokinetics AUC0-last
+11 more
Other outcome measures
Evaluate changes in patient-reported outcomes
Explore the effect of O[6] methylguanine-DNA methyltransferase (MGMT) methylation
Impact of re-resection
+2 more

Side effects data

From 2016 Phase 2 trial • 83 Patients • NCT01067469
39%
ALT/SGPT
17%
anorexia
14%
AST/SGOT
11%
alk phos
6%
Fracture
6%
allergic rhinitis
6%
CNS Ischemia
6%
Confusion
3%
Headache
3%
Perforation, GI
3%
Vessel injury - artery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Dose Bevacizumab
Low Dose Bevacizumab + Lomustine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BerubicinExperimental Treatment1 Intervention
Berubicin intravenously infused will be administered at a dose of 7.1 mg/m2 as free base as a 2 hour intravenous (IV) infusion once daily for 3 consecutive days followed by 18 days off study drug (each cycle = 21 days) Each treatment cycle is 21 days. Subjects will be allowed to continue on treatment at the discretion of the Investigator if there is no evidence of disease progression and the subject is not experiencing unacceptable toxicity as well as if both the subject and Investigator agree that further therapy is in the subject's best interest.
Group II: Lomustine (CCNU, CeeNU®, or Gleostine®) capsulesActive Control1 Intervention
Lomustine (CCNU, CeeNU®, or Gleostine®) capsules will be administered at the institutionally-approved dose and regimen or per the full prescribing information/summary of product characteristics.

Find a Location

Who is running the clinical trial?

Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,177 Total Patients Enrolled
1 Trials studying Glioblastoma
50 Patients Enrolled for Glioblastoma
CNS Pharmaceuticals, Inc.Lead Sponsor
Sandra Silberman, MD, PhDStudy ChairCNS Pharmaceuticals, Inc.
2 Previous Clinical Trials
31 Total Patients Enrolled

Media Library

Berubicin (Anthracenedione) Clinical Trial Eligibility Overview. Trial Name: NCT04762069 — Phase 2
Glioblastoma Research Study Groups: Lomustine (CCNU, CeeNU®, or Gleostine®) capsules, Berubicin
Glioblastoma Clinical Trial 2023: Berubicin Highlights & Side Effects. Trial Name: NCT04762069 — Phase 2
Berubicin (Anthracenedione) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762069 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any harmful side-effects associated with Berubicin?

"There is some data supporting Berubicin's safety, but none yet to suggest that it is effective. It received a score of 2."

Answered by AI

How many different hospitals are currently conducting this trial?

"This ongoing clinical trial has 42 active sites, with the three primary locations being Mayo Clinic in Rochester, Minnesota; Thomas Jefferson University in Philadelphia, Pennsylvania; and Baylor Research Institute in Dallas, Texas."

Answered by AI

How many study participants are there in total?

"To move forward with the study, 210 patients that meet the pre-determined inclusion criteria will need to be recruited. The sponsor, CNS Pharmaceuticals Inc., has multiple clinical trial sites across America, including Mayo Clinic in Rochester, Minnesota and Thomas Jefferson University in Philadelphia, Pennsylvania."

Answered by AI

Are patients being actively recruited for this clinical trial at this time?

"Yes, as displayed on clinicaltrials.gov, this clinical trial is recruiting patients. According to the website, the trial was first posted on May 18th, 2021 and last edited on November 7th, 2022."

Answered by AI

What other research has been conducted using Berubicin?

"Berubicin was first studied in the year 2003 at M. D. Anderson Cancer Center at University of Texas. To date there have been 28 completed clinical trials and 22 more that are ongoing. A large number of these studies are based in Rochester, Minnesota."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Georgia
How old are they?
18 - 65
What site did they apply to?
Piedmont Healthcare
Moffitt Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme
2021. "A Study of Berubicin in Adult Subjects With Recurrent Glioblastoma Multiforme". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04762069.
All > Glioblastoma Long Beach
~22 spots leftby Sep 2024
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