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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

No Placebo-Only Group

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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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

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 more

Other study objectives

Evaluate changes in patient-reported outcomes

Explore the effect of O[6] methylguanine-DNA methyltransferase (MGMT) methylation

Impact of re-resection

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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