What side effects are associated with this type of intervention?

Common treatments for Glioblastoma, such as chemotherapy with carboplatin, often result in side effects including nausea, vomiting, fatigue, and increased risk of infection due to lowered blood cell counts. Radiation therapy, another common treatment, can cause side effects like hair loss, skin irritation, and cognitive changes. When using advanced techniques like the Exablate Model 4000 Type 2 system to open the blood-brain barrier, additional side effects may include headaches, scalp pain, and a sensation of feeling cold.

What prior FDA approvals exist?

The FDA has approved several treatments for glioblastoma, including temozolomide and bevacizumab. Temozolomide is an oral alkylating agent that has shown efficacy in treating glioblastoma, particularly when used in conjunction with radiotherapy. Bevacizumab, an anti-VEGF monoclonal antibody, helps reduce tumor vascularization and edema. While these treatments do not specifically involve opening the blood-brain barrier, enhancing drug delivery across the BBB, as studied with the Exablate Model 4000 Type 2 system, could potentially improve their efficacy by allowing higher concentrations of these drugs to reach the tumor site.

What other types of research exist?

Promising alternatives to the Exablate Model 4000 Type 2 system for glioblastoma patients include: 1) Focused ultrasound combined with microbubbles, which temporarily disrupts the BBB to allow drug delivery. 2) Convection-enhanced delivery (CED), which uses catheters to deliver drugs directly into the brain tissue. 3) Nanoparticle-based delivery systems, which can cross the BBB and release therapeutic agents directly at the tumor site. 4) Intranasal drug delivery, which bypasses the BBB by delivering drugs through the nasal cavity. These methods are currently being explored in clinical trials and have shown potential in enhancing drug delivery to the brain.

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Alkylating agents

BBBD + Carboplatin for Glioblastoma

Phase 1 & 2

Waitlist Available

Research Sponsored by InSightec

Eligibility Criteria Checklist

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

Must have

Must be between 18-80 years old

Recovered to grade 0 or 1 or pre-treatment baseline from clinically significant toxic effects of prior therapy

Must not have

Women who are pregnant or breastfeeding

Cerebellar spinal cord or brain stem tumor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that uses ultrasound to help a chemotherapy drug reach the brain in adults with recurring brain cancer.

Who is the study for?

This trial is for adults aged 18-80 with recurrent glioblastoma who are planning to undergo carboplatin monotherapy. Participants must have recovered from previous treatments, not be pregnant or breastfeeding, use effective contraception, and be able to give consent. Exclusions include certain heart conditions, bleeding disorders, severe kidney issues, active infections or other cancers requiring treatment.

What is being tested?

The study tests the safety of using the Exablate Model 4000 Type 2 system to temporarily open the blood-brain barrier in patients with recurrent glioblastoma during carboplatin chemotherapy. The goal is to see if this method can improve treatment delivery directly to brain tumors.

What are the potential side effects?

Potential side effects may include discomfort from lying still during MRI scans used in the procedure and reactions related to carboplatin such as nausea, low blood counts leading to increased infection risk, hair loss and nerve damage causing numbness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I have recovered from major side effects of my previous treatments.

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My diagnosis is glioblastoma confirmed by tissue analysis.

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My cancer has worsened after the first treatment.

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I am scheduled for treatment with Carboplatin alone.

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I can speak and communicate verbally.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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My cancer is located in my cerebellum, spinal cord, or brain stem.

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I have had a recent bleeding in my brain.

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I have very high blood pressure.

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I have an active Hepatitis B, Hepatitis C, or HIV infection.

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I have another cancer that is getting worse or needs treatment.

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I have a history of bleeding disorders or my tumor has bled on its own.

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I am currently on antibiotics for a cranial or systemic infection.

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I cannot lie on my back or have severe claustrophobia that medication can't help.

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My kidneys do not work well.

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I have heart disease or unstable blood pressure and heart rate.

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I have experienced side effects from carboplatin chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 12 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

Magnetic Resonance Imaging

Occurrence of Adverse Events

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Exablate BBBD with carboplatinExperimental Treatment2 Interventions

Carboplatin will be administered via IV infusion about every 4 weeks for up to 6 cycles. The dosage will be calculated based on subject's creatinine level. On the day of planned carboplatin therapy, subjects will undergo Exablate procedure to open the blood-brain-barrier in the targeted cancerous brain areas prior to carboplatin administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

0 / 18Eligibility criteria met

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 treatments often face the challenge of the blood-brain barrier (BBB), which limits drug delivery to the tumor site. The Exablate Model 4000 Type 2 system uses focused ultrasound to temporarily open the BBB, allowing for enhanced delivery of chemotherapeutic agents like carboplatin. This approach is significant for glioblastoma patients as it potentially increases the efficacy of the treatment by ensuring higher concentrations of the drug reach the tumor. Other common treatments include temozolomide, which works by damaging the DNA of cancer cells, and bevacizumab, an angiogenesis inhibitor that restricts the tumor's blood supply. These treatments are crucial as they target the aggressive nature of glioblastoma, aiming to slow tumor growth and improve patient outcomes.