5-ALA + Ultrasound for Brain Cancer

No longer recruiting at 3 trial locations

Overseen By Alpheus Medical

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Alpheus Medical, Inc.

Must not be taking: Phototoxic drugs

Disqualifiers: Pregnancy, Brainstem tumors, Porphyria, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a combination of the drug 5-aminolevulinic acid (5-ALA) and ultrasound, delivered using the CV01 device, can safely treat high-grade glioma, a type of brain cancer that has recurred after treatment. The trial aims to assess the safety of this new approach and how patients tolerate it. Suitable candidates have a confirmed high-grade glioma that has returned after radiation, with tumors located in a specific brain area. For those dealing with this type of recurrent brain cancer, this trial could be an option to consider. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new approach.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must avoid certain phototoxic drugs (like St. John's wort and some antibiotics) for 24 hours before and after taking 5-ALA.

What prior data suggests that this combination of 5-ALA and CV01-delivered ultrasound is safe for treating brain cancer?

Research shows that 5-aminolevulinic acid (5-ALA), when combined with ultrasound, is undergoing safety testing for brain cancer treatment. 5-ALA has been used in cancer treatments before, and current studies explore its effectiveness with ultrasound in targeting tumor cells.

The treatment is in early testing stages, focusing on safety and patient tolerance. Early research has not identified major safety concerns, but since this is a new application for 5-ALA, careful monitoring remains crucial. So far, the combination has been generally well-tolerated, though some side effects may occur, such as mild nausea or sensitivity to light, which have appeared in other uses of 5-ALA.

In summary, current findings suggest the treatment is safe, but further research is necessary for confirmation. Trial participants will be closely monitored to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of 5-ALA and CV01-delivered ultrasound for brain cancer because it introduces a novel approach to treatment. Unlike standard treatments, which often rely on surgery, radiation, or chemotherapy, 5-ALA makes cancer cells glow under certain lights, helping in tumor visualization and removal. The addition of CV01-delivered ultrasound is groundbreaking because it enhances the delivery of the drug to the brain, potentially making the treatment more effective. This combination may allow for more precise targeting of brain tumors, reducing damage to surrounding healthy tissue and improving outcomes for patients.

What evidence suggests that 5-ALA combined with CV01-delivered ultrasound is effective for brain cancer?

Research has shown that a treatment combining 5-aminolevulinic acid (5-ALA) with ultrasound, which participants in this trial will receive, may help treat high-grade glioma, a type of brain cancer. This treatment, known as sonodynamic therapy (SDT), targets and kills cancer cells without harming nearby brain tissue. It works by making cancer cells more sensitive to sound waves, which then destroy the cells. Early research and studies suggest that this method could effectively shrink tumors. Although more information is needed, these early results offer promise for individuals with recurring high-grade glioma. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 18 with a confirmed high-grade glioma brain tumor that has recurred after radiotherapy. They must understand the study, be willing to follow its rules, and have good enough health as shown by specific blood tests and organ function measures. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days prior to first 5-ALA administration

I have a high-grade brain tumor that has come back after radiation treatment.

Patient must provide informed consent, stating understanding of the procedures and investigational nature of the study treatment, and willingness to comply with study requirements

Exclusion Criteria

I do not have any severe health conditions that could affect my participation in the study.

I have a type of porphyria.

I haven't had a stroke or brain bleeding in the last 6 months not related to brain tumor surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 5-ALA as a sonosensitizer prior to CV01-delivered ultrasound, re-administered every 4 weeks

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• 5 Aminolevulinic Acid
• CV01-delivered ultrasound

Trial Overview

The trial is testing the safety of combining a drug called 5-aminolevulinic acid (5-ALA) with CV01-delivered ultrasound for sonodynamic therapy in patients whose aggressive brain tumors have come back after treatment.

How Is the Trial Designed?

Group I: 5-ALA with CV01 Experimental Treatment 2 Interventions

5-aminolevulinic acid \[5-ALA\] with CV01-delivered ultrasound

Who Is Running the Clinical Trial?

Alpheus Medical, Inc.

Lead Sponsor

Trials

2

Recruited

40+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12113153/

Sonodynamic Therapy Using 5-Aminolevulinic Acid for ...

This review provides an insight into the use of focused and diffuse ultrasound in the treatment of GBM using 5-ALA-SDT, its mechanism of action and immune ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05362409

NCT05362409 | Study to Evaluate 5-ALA Combined With ...

The CV01 device will deliver non-ablative, low-intensity ultrasound to deep regions of the brain to induce apoptosis of cancer cells.

3.

trials.braintumor.org

trials.braintumor.org/trials/NCT06665724

Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5 ...

The study will accrue 10 evaluable high-grade glioma patients. Patients who qualify will receive sonodynamic therapy (5 ALA combined with CV01-delivered ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11968568/

Sonodynamic therapy with a single neoadjuvant, diffuse ...

Sonodynamic therapy using ultrasound and 5-ALA is presently being explored in both pre-clinical and clinical settings for brain tumors using ...

5.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06665724/clinical-trial-evaluating-safety-of-5-aminolevulinic-acid-5-ala-combined-with-cv01-delivery-of-ultrasound-for-sonodynamic-therapy-sdt-in-patients-with-newly-diagnosed-high-grade-glioma-hgg-prior-to-resection-and-standard-adjuvant-therapy-ala-sdt-glioma-401

Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid ...

This trial is designed to evaluate safety and explore possible efficacy of 5-aminolevulinic acid hydrochloride (5-ALA HCl, Gliolan®) with CV01 delivery of ...

6.

academic.oup.com

academic.oup.com/neuro-oncology/article/26/Supplement_8/viii319/7890425

Neuro-Oncology | Oxford Academic

We report the first use of the novel CV-01 device delivering non-ablative low-intensity diffuse ultrasound (LIDU) with oral 5-ALA as a recurrent ...