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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.
Must not have
Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg and/or diastolic BP >100 mmHg) sustained over 2 measurements.
Heart disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 4 years.
Awards & highlights
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My blood pressure is not higher than 150/100 mmHg.
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I have heart disease.
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I do not currently have hepatitis B, hepatitis C, HIV, COVID-19, or any other serious infection.
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I have seizures that aren't controlled by standard treatments or have needed hospital care.
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I have received more than 550 mg/m2 of anthracycline.
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I have been treated with bevacizumab before.
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I have been treated with lomustine before.
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I have received chemotherapy for my brain tumor after the first treatment.
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My cancer has an IDH mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of 4 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 4 years.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival
Secondary study objectives
Event Free Survival
Overall Response Rate
Plasma Pharmacokinetics AUC0-last
+11 moreOther study objectives
Evaluate changes in patient-reported outcomes
Explore the effect of O[6] methylguanine-DNA methyltransferase (MGMT) methylation
Impact of re-resection
+2 moreSide effects data
From 2016 Phase 2 trial • 83 Patients • NCT0106746939%
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
63 Previous Clinical Trials
14,560 Total Patients Enrolled
1 Trials studying Glioblastoma
5 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are a woman who is currently breastfeeding.My brain tumor has not spread to the spinal cord, brain linings, or ventricles.My blood pressure is not higher than 150/100 mmHg.I have heart disease.I do not currently have hepatitis B, hepatitis C, HIV, COVID-19, or any other serious infection.I have seizures that aren't controlled by standard treatments or have needed hospital care.My MRI shows significant brain changes but I don't have severe symptoms.I have received more than 550 mg/m2 of anthracycline.My brain tumor has grown or returned, confirmed by recent MRI scans.My organs and bone marrow are healthy enough for chemotherapy.I do not have any health or social issues that would prevent me from following the study requirements.I've had surgery or radiation for my cancer without chemotherapy or immunotherapy.I have been cancer-free for over 5 years, except for certain skin, cervix, breast, bladder, or prostate cancers.I can care for myself but may need occasional help.I have been treated with bevacizumab before.I have been treated with lomustine before.My diagnosis of GBM is confirmed by a pathology report from a biopsy or surgery.My cancer's MGMT methylation status is known.I am 18 years old or older.I have received chemotherapy for my brain tumor after the first treatment.I have recovered from previous cancer treatment side effects, except for hair loss.My cancer has an IDH mutation.My chronic conditions like diabetes or COPD have been well-managed for the last 3 months.I've had only one treatment course for my condition, or used TTFields as my first treatment.To join the study, you must meet certain requirements, and not meet certain restrictions.
Research Study Groups:
This trial has the following groups:- Group 1: Lomustine (CCNU, CeeNU®, or Gleostine®) capsules
- Group 2: Berubicin
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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