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Berubicin Hydrochloride

Berubicin Hydrochloride is an experimental drug currently being studied in clinical trials for the treatment of various types of brain cancer, including glioblastoma multiforme and high-grade gliomas. These trials aim to evaluate the drug’s safety, effectiveness, and optimal dosing in both adult and pediatric patients with brain tumors that have not responded to standard treatments or have recurred after initial therapy.

Table of Contents

What is Berubicin Hydrochloride?

Berubicin Hydrochloride, also known as RTA 744, is a new type of drug called an anthracycline[3]. Anthracyclines are a class of drugs commonly used in cancer treatment. What makes Berubicin special is its ability to cross the blood-brain barrier, which is a protective layer that prevents many substances, including most drugs, from entering the brain[3]. This unique property allows Berubicin to potentially treat cancers in the brain more effectively than other drugs.

What Conditions Does Berubicin Treat?

Berubicin is being studied for the treatment of several types of brain cancers:

  • Recurrent Glioblastoma Multiforme (GBM): This is an aggressive type of brain cancer that has come back after initial treatment[1].
  • High Grade Gliomas (HGG) in children: These are fast-growing brain tumors that have not responded well to standard treatments or have come back after treatment[2].
  • Brain Metastases from Breast Cancer: This refers to breast cancer that has spread to the brain[3].

How Does Berubicin Work?

Berubicin works differently from many other cancer drugs. It has shown the ability to bypass certain proteins in the body that usually prevent drugs from entering the brain[3]. These proteins, with names like Multidrug Resistance Protein 1, Breast Cancer Resistance Protein, and P-glycoprotein, act like bouncers at a club, keeping many substances out of the brain. Berubicin can slip past these “bouncers,” allowing it to reach brain tumors more effectively.

How is Berubicin Administered?

Berubicin is given as an intravenous (IV) infusion, which means it’s delivered directly into the bloodstream through a vein. The specific dosing schedule can vary depending on the study and the patient’s condition, but generally:

  • For adults with recurrent GBM, Berubicin is typically given as a 2-hour IV infusion once daily for 3 consecutive days, followed by 18 days off. This 21-day period is considered one treatment cycle[1].
  • For children with HGG, the infusion is given over 1 hour for 3 consecutive days, followed by 18 days off[2].

Current Clinical Trials

Berubicin is currently being studied in several clinical trials:

  • A Phase 1b/2 study in adults with recurrent GBM, which aims to confirm the effectiveness and safety of Berubicin[1].
  • A Phase 1 study in children with HGG, which is looking at the safety, how the drug moves through the body (pharmacokinetics), and the best dose to use[2].
  • A Phase 2 study in patients with breast cancer that has spread to the brain, which is examining whether Berubicin can help reduce brain tumors in these patients[3].

Potential Side Effects

While the full range of side effects is still being studied, early research suggests that Berubicin is generally well-tolerated[3]. However, as with any cancer treatment, there may be side effects. These could potentially include:

  • Fatigue
  • Nausea
  • Changes in blood cell counts
  • Other effects common to chemotherapy drugs

It’s important to note that the side effects can vary from person to person, and not everyone will experience the same effects. The clinical trials currently underway are closely monitoring patients for any adverse reactions to help better understand the safety profile of Berubicin.

Aspect Details
Drug Name Berubicin Hydrochloride (also known as RTA 744)
Cancer Types Recurrent Glioblastoma Multiforme, High-Grade Gliomas, Brain Metastases from Breast Cancer
Administration Intravenous infusion, typically over 1-2 hours
Dosing Schedule Once daily for 3 consecutive days, followed by 18 days off (21-day cycles)
Key Features Ability to cross the blood-brain barrier, potential to overcome drug resistance mechanisms
Primary Outcomes Objective Response Rate, Maximum Tolerated Dose, Recommended Phase 2 Dose
Secondary Outcomes Safety profile, Pharmacokinetics, Event-Free Survival, Disease Control Rate
Patient Populations Adults with recurrent GBM, Pediatric patients with progressive/refractory/recurrent HGG, Breast cancer patients with brain metastases
Trial Phases Phase 1, Phase 1b/2, Phase 2

FAQ

  • What is Berubicin Hydrochloride? Berubicin Hydrochloride is an experimental drug being tested for the treatment of brain cancers. It belongs to a class of drugs called anthracyclines and has shown the ability to cross the blood-brain barrier, which is important for treating brain tumors.
  • What types of brain cancer is Berubicin being tested for? Berubicin is being studied in clinical trials for recurrent glioblastoma multiforme (GBM) in adults, high-grade gliomas in children, and brain metastases from breast cancer.
  • How is Berubicin administered to patients? Berubicin is given as an intravenous (IV) infusion. In the trials, it is typically administered once daily for 3 consecutive days, followed by 18 days off, in 21-day cycles.
  • What are the main goals of the Berubicin clinical trials? The main goals of these trials are to determine the safety and effectiveness of Berubicin, find the optimal dose for treatment, and assess its impact on tumor size, progression-free survival, and overall survival in patients with brain cancer.
  • Are there any early results from the Berubicin trials? While specific results are not provided in the given information, the drug has shown some anti-tumor activity in early studies, particularly in patients with recurrent glioblastoma multiforme. However, more research is needed to confirm its effectiveness and safety profile.

Ongoing Clinical Trials on Berubicin Hydrochloride

  • Study of Berubicin versus Lomustine in adult patients with recurrent Glioblastoma Multiforme after first-line treatment failure

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

  • Study on the Safety and Effectiveness of Berubicin for Patients with Central Nervous System Lymphomas

    Not recruiting

    1 1
    Investigated drugs:
    Poland

Glossary

  • Glioblastoma Multiforme (GBM): A fast-growing and aggressive type of brain tumor that forms from glial cells (cells that support nerve cells).
  • High-Grade Glioma (HGG): A group of malignant brain tumors that grow and spread quickly, including glioblastomas and anaplastic astrocytomas.
  • Recurrent Cancer: Cancer that has returned after a period of time during which the cancer could not be detected.
  • Refractory Cancer: Cancer that does not respond to treatment.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including its absorption, distribution, metabolism, and excretion.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug recommended for further testing in Phase 2 clinical trials based on safety and efficacy data from earlier studies.
  • Dose-Limiting Toxicity (DLT): Side effects that are severe enough to prevent an increase in the dose of a drug being tested.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Event-Free Survival (EFS): The length of time after treatment during which a patient remains free of certain complications or events related to their disease.
  • Disease Control Rate (DCR): The percentage of patients whose cancer shrinks or remains stable in response to treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • Overall Survival (OS): The length of time from the start of treatment that patients are still alive.
  • Blood-Brain Barrier: A protective barrier that prevents many substances, including some drugs, from entering the brain from the bloodstream.
  • Anthracycline: A class of drugs used in cancer chemotherapy that are extracted from certain types of Streptomyces bacteria.

References

  1. https://clinicaltrials.gov/study/NCT04915404
  2. https://clinicaltrials.gov/study/NCT05082493
  3. https://clinicaltrials.gov/study/NCT00538343