What side effects are associated with this type of intervention?

Carboplatin, a chemotherapy agent used in glioblastoma treatment, commonly causes side effects such as thrombocytopenia, neutropenia, anemia, nausea, vomiting, and sensory neuropathy. The SonoCloud-9 device, which uses ultrasound to open the blood-brain barrier, aims to improve drug delivery to brain tumors. Potential risks of this device could include localized inflammation or brain tissue damage. Combining these treatments may result in a cumulative effect of their individual side effects.

What prior FDA approvals exist?

Glioblastoma treatment has seen several FDA-approved therapies, primarily focusing on chemotherapy, radiation, and targeted therapies. Temozolomide, an oral alkylating agent, is a standard chemotherapy drug approved for Glioblastoma. Bevacizumab, an anti-angiogenic drug, is also approved for recurrent Glioblastoma. While Carboplatin has shown efficacy in laboratory settings, its use in Glioblastoma is limited due to the blood-brain barrier (BBB). The SonoCloud-9 trial explores the novel approach of using ultrasound to transiently open the BBB, potentially enhancing Carboplatin delivery to brain tumor tissue. This innovative method aims to improve the efficacy of existing chemotherapies by overcoming the BBB challenge.

What other types of research exist?

Promising novel alternatives for Glioblastoma treatment in 2024 include: 1) Vismodegib and Sonidegib, which are hedgehog pathway inhibitors showing efficacy in brain tumors. 2) Boron Neutron Capture Therapy (BNCT), which targets cancer cells more precisely. 3) Immunotherapy approaches such as PD-1 inhibitors (e.g., Nivolumab, Pembrolizumab) that enhance the immune system's ability to fight cancer. 4) Advanced gene therapy techniques and personalized medicine approaches targeting specific genetic mutations in glioblastoma.

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Chemotherapy

Ultrasound-Assisted Chemotherapy for Glioblastoma (SONOBIRD Trial)

Phase 3

Recruiting

Research Sponsored by CarThera

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests a new method to treat recurrent brain cancer using an ultrasound device called SonoCloud-9. The device helps open the brain's protective barrier so that more of the chemotherapy drug carboplatin can reach the tumor. The goal is to see if this combination makes the treatment more effective. Carboplatin has been used in various studies for treating high-grade gliomas and glioblastomas, often showing modest efficacy due to low tissue concentration when delivered intravenously.

Who is the study for?

Adults over 18 with confirmed glioblastoma who've had prior surgery, radiotherapy, and chemotherapy can join. They must have a tumor that's grown after treatment but is less than 5 cm wide. Participants need good organ function, no severe allergies to trial drugs or device components, and not be on certain medications like anti-platelet drugs.

What is being tested?

The trial tests if using SonoCloud-9 (SC9), an ultrasound device designed to temporarily open the blood-brain barrier (BBB), increases the effectiveness of Carboplatin in treating recurrent glioblastoma compared to standard chemotherapies Lomustine or Temozolomide alone.

What are the potential side effects?

Possible side effects include reactions related to opening the BBB such as temporary inflammation or discomfort at the site of ultrasound application. Carboplatin may cause nausea, fatigue, low blood counts increasing infection risk, and nerve damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months 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 (OS)

Secondary study objectives

Overall survival at 12 months (OS12)

Overall survival at 18 months (OS18)

Progression Free Survival (PFS)

+2 more

Other study objectives

Safety and Tolerability

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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: Experimental Arm: SonoCloud-9 Ultrasound + CarboplatinExperimental Treatment2 Interventions

The SonoCloud-9 (SC9) device will be implanted in the skull bone window upon completion of tumor resection and routine craniotomy. Carboplatin (CBDCA) will be administered intravenously prior to sonication. The CBDCA/SC9 treatment will be repeated every 3 weeks (depending on patient's tolerability) until disease progression or as clinically indicated. Administration of up to 7 cycles is planned.

Group II: Control Arm: SoC single agent chemotherapy TMZ or CCNUActive Control2 Interventions

Standard of Care (SoC) treatment with either temozolomide (TMZ) or lomustine (CCNU). Standard TMZ chemotherapy as a single oral dose every 4 weeks for up to 6 cycles. Standard CCNU chemotherapy as a single oral dose every 6 weeks for up to 4 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Glioblastoma is a highly aggressive brain tumor with limited treatment options due to the protective nature of the blood-brain barrier (BBB), which restricts drug delivery to the brain. The SonoCloud-9 device uses ultrasound technology to temporarily open the BBB, allowing for enhanced delivery of chemotherapeutic agents like carboplatin. Carboplatin is a platinum-based chemotherapy that works by causing DNA damage in cancer cells, leading to cell death. The combination of SonoCloud-9 and carboplatin aims to increase the concentration of the drug in the brain tumor, potentially improving treatment efficacy. This approach is significant for glioblastoma patients as it addresses the critical challenge of drug delivery to the brain, potentially leading to better outcomes.