Berubicin for Glioblastoma

Recruiting in Palo Alto (17 mi)

+65 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: CNS Pharmaceuticals, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is an open-label, multicenter, randomized, parallel, 2-arm, efficacy and safety study. Patients with GBM after failure of standard first line therapy will be randomized in a 2:1 ratio to receive berubicin or lomustine for the evaluation of OS. Additional endpoints will include response and progression outcomes evaluated by a blinded central reviewer for each patient according to RANO criteria. A pre-planned, non-binding futility analysis will be performed after approximately 30 to 50% of all planned patients have completed the primary endpoint at 6 months. This review will include additional evaluation of safety as well as secondary efficacy endpoints. Enrollment will not be paused during this interim analysis.

Eligibility Criteria

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.

Inclusion Criteria

My brain tumor has not spread to the spinal cord, brain linings, or ventricles.

My brain tumor has grown or returned, confirmed by recent MRI scans.

I can care for myself but may need occasional help.

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've had only one treatment course for my condition, or used TTFields as my first treatment.

Exclusion Criteria

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.

I have received more than 550 mg/m2 of anthracycline.

I have been treated with bevacizumab before.

I have been treated with lomustine before.

I have received chemotherapy for my brain tumor after the first treatment.

My cancer has an IDH mutation.

Participant Groups

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.

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.