What side effects are associated with this type of intervention?

Common treatments for brain tumors, such as surgery, radiation, and chemotherapy, can lead to side effects including neurocognitive decline, fatigue, and increased risk of infections. Specific to treatments involving 5-aminolevulinic acid (5-ALA), which is a photosensitizer, side effects can include photosensitivity reactions, pain during treatment, and localized skin reactions. When combined with ultrasound for sonodynamic therapy, additional side effects may include localized tissue damage and inflammation due to the production of reactive oxygen species. Overall, the side effects depend on the treatment modality and the patient's individual response.

What prior FDA approvals exist?

The FDA has approved several treatments for brain tumors, including temozolomide, a chemotherapy drug often used in conjunction with radiation therapy for glioblastoma. Another notable approval is for bevacizumab, an anti-angiogenic drug used for recurrent glioblastoma. While 5-aminolevulinic acid (5-ALA) is primarily known for its use in fluorescence-guided surgery to enhance the visualization and resection of malignant gliomas, it is currently being studied in combination with ultrasound (CV01) for its potential to produce reactive oxygen species and destroy cancer cells. This investigational approach is similar to other photodynamic therapies that utilize photosensitizers activated by light or other forms of energy to target and kill cancer cells.

What other types of research exist?

Promising novel alternatives for brain tumor treatment in 2024 include: 1) Tumor Treating Fields (TTFields) - a non-invasive therapy using electric fields to disrupt cancer cell division. 2) CAR-T cell therapy - a type of immunotherapy where a patient's T cells are modified to target cancer cells. 3) Oncolytic virus therapy - using genetically modified viruses to selectively infect and kill cancer cells. 4) Bevacizumab - an anti-angiogenic drug that inhibits blood vessel growth in tumors. 5) Optune - a wearable device delivering TTFields, specifically approved for glioblastoma. These therapies are in various stages of clinical development and have shown promise in improving outcomes for brain tumor patients.

← Back to Search

Photosensitizing Agent

5-ALA + Ultrasound for Brain Cancer

Phase 1

Waitlist Available

Research Sponsored by Alpheus Medical, Inc.

Eligibility Criteria Checklist

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

Must have

≥ 18 years of age

Previous histopathologically confirmed diagnosis of high-grade glioma and radiographic evidence of recurrence after prior therapy with radiotherapy. Eligible histologies include (according to WHO classification 2021): Astrocytoma, WHO grade 3 and 4 (including subtypes), Oligodendroglioma WHO grade 3 (including subtypes)

Must not have

Acute or chronic types of porphyria

Any other concurrent severe or uncontrolled concomitant medical condition that could compromise participation in the study (e.g., clinically significant pulmonary disease, cardiac disease, clinically significant psychiatric or neurological disorder, active or uncontrolled infection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for aggressive brain tumors using a special drug and a sound wave machine. The drug makes the cancer cells more sensitive to sound waves, which then help to kill the cancer cells. It aims to help patients whose tumors are hard to treat with standard methods.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include sensitivity reactions due to the drug or porphyrins, issues related to ultrasound exposure on the skull or brain tissue, and general risks associated with taking investigational treatments.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Select...

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

Select...

My tumor is located in the upper part of my brain.

Select...

My blood tests show normal immune, liver, kidney, and clotting function.

Exclusion Criteria

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

Select...

I have a type of porphyria.

Select...

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

Select...

I need urgent treatment for severe swelling.

Select...

I have received more than 64 Gy of radiation therapy.

Select...

My cancer is located in the lower part of my brain or brainstem.

Select...

My cancer originates in my spinal cord.

Select...

I am aware that I have HIV.

Select...

I am not pregnant or breastfeeding.

Select...

I have a stomach or intestine problem that affects how my body absorbs food.

Select...

My brain tumor affects both sides of my brain or the area that connects them.

Select...

I cannot have an MRI or use contrast dyes due to health reasons.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Incidence of adverse events (Safety and Tolerability)

To determine the Maximum Tolerable Duration (MTDu)

Secondary study objectives

Assessment of Overall response rate (ORR)

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: 5-ALA with CV01Experimental Treatment2 Interventions

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

0 / 15Eligibility 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

The most common treatments for brain tumors include surgical resection, radiation therapy, chemotherapy, and emerging methods like 5-aminolevulinic acid (5-ALA) combined with ultrasound. 5-ALA is a photosensitizer that, when activated by ultrasound, produces reactive oxygen species (ROS) to destroy cancer cells, a process known as sonodynamic therapy (SDT). This targeted approach minimizes damage to healthy tissue. Surgical resection aims to remove as much of the tumor as possible, while radiation therapy damages the DNA of cancer cells to induce cell death. Chemotherapy uses drugs to kill rapidly dividing cells. These treatments are essential for reducing tumor size, controlling growth, and improving patient outcomes and quality of life.