Berubicin for Glioblastoma

Recruiting at65 trial 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.

Research Team

Sandra Silberman, MD, PhD

Principal Investigator

CNS Pharmaceuticals, Inc.

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.

Women of childbearing potential must agree to practice a highly effective method of contraception beginning at least 28 days before the start of treatment until at least 6.25 months after the last dose of study drug. Male study patients and their female sexual partners of childbearing potential must agree to practice a highly effective method of contraception starting from the time of informed consent until at least 3.5 months (no less than 104 days) after the last dose of study drug.

Written informed consent from the patient or their legally authorized representative (LAR) prior to any study-related procedure, and willing and able to comply with the protocol and aware of the investigational nature of this study.

Exclusion Criteria

You are a woman who is currently breastfeeding.

My blood pressure is not higher than 150/100 mmHg.

I have heart disease.

Treatment Details

Interventions

• Berubicin (Anthracenedione)
• Lomustine (Nitrosourea)

Trial Overview 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.

Participant Groups

Group I: Berubicin Experimental Treatment 1 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®) capsules Active Control 1 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.

Who Is Running the Clinical Trial?

CNS Pharmaceuticals, Inc.

Lead Sponsor

Trials

1

Recruited

210+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Peter Benton

Worldwide Clinical Trials

Chief Executive Officer since 2024

MBA in Finance and Strategy from The Wharton School, University of Pennsylvania; Bachelor's degree in Mechanical Engineering from Northeastern University

Dr. Michael F. Murphy

Worldwide Clinical Trials

Chief Medical Officer since 1997

MD and PhD in Pharmacology with training at Tulane University, Stanford University, and Mt. Sinai School of Medicine