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A study of 5-aminolevulinic acid with radiotherapy (radiodynamic therapy) for patients with first recurrence of glioblastoma brain tumor

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with recurrent glioblastoma, which is a type of brain tumor that has returned after initial treatment. The study tests a new treatment approach called radiodynamic therapy (RDT), which combines a medication called 5-Aminolevulinic acid (given as an oral solution) with radiation therapy.

The treatment involves taking Gliolan (the brand name for 5-Aminolevulinic acid) by mouth in combination with radiation therapy sessions. The main goal of this research is to determine the highest safe dose of the medication that can be given repeatedly during radiation therapy treatment without causing unacceptable side effects.

During the study, participants will receive different doses of the medication along with radiation therapy over a four-week period. The treatment schedule will be carefully monitored to evaluate how well patients tolerate the combination therapy and to assess any side effects that may occur. This includes monitoring for any effects on neurological function and skin reactions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medical evaluation
A medical assessment will confirm the presence of recurrent glioblastoma (a type of brain tumor that has returned after initial treatment)
Laboratory tests will check liver function, kidney function, and blood clotting
For women of childbearing age, a pregnancy test must be completed within 72 hours before starting treatment
Step 2
Treatment preparation
The treatment combines two elements: 5-Aminolevulinic acid (5-ALA) medication and radiation therapy
The medication comes as Gliolan 30 mg/ml powder that will be prepared as a solution to take by mouth
The treatment plan will be scheduled over a 4-week period
Step 3
Radiation therapy sessions
You will receive radiotherapy treatments over 4 weeks
The radiation will be delivered to specific areas using focused beams
The oral medication will be given according to a schedule determined by your medical team
Step 4
Monitoring during treatment
Regular checks will monitor for any side effects
Special attention will be paid to neurological and skin reactions
Any new symptoms or side effects rated as moderate or severe will be documented
Step 5
Safety precautions
You must use effective contraception during the entire study and for 6 months afterward
Male patients must use condoms during treatment and for 90 days after
Avoid sun exposure and bright lights during treatment period due to potential skin sensitivity

Who can join the trial?

10 criteria

Must be at least 18 years old
Must provide written informed consent after receiving comprehensive information about the study
Must have recurrent glioblastoma in the upper part of the brain after initial surgery and treatment, including second or third recurrences
Must have histological confirmation (examination of tissue under microscope) of recurring glioblastoma
Must have a Karnofsky Performance Score of 60 or higher (a measure of ability to perform daily activities)
Must have adequate kidney function: - Creatinine less than 3 times the normal limit - eGFR (kidney filtration rate) of 60 ml/min or higher
Must have adequate liver function: - Bilirubin less than 1.5 times the normal limit - Liver enzymes (ALT and AST) less than 3 times the normal limit
Must have normal blood clotting values as determined by the doctor
For women who can become pregnant: must have a negative pregnancy test within 72 hours before starting treatment
Both men and women who can have children must use highly effective contraception during the study and for at least 6 months after the last treatment

Who cannot join the trial?

15 criteria

Prior history of radiotherapy (radiation treatment) to the brain within the last 12 months
Presence of other active cancers requiring treatment
Severe allergic reactions to 5-ALA (a drug used in the study)
Pregnancy or breastfeeding
Inability to undergo MRI scans (magnetic resonance imaging) due to metal implants or claustrophobia
Serious heart, liver, or kidney problems
Current participation in other clinical trials
Use of medications that could interfere with the study treatment
Inability to give informed consent
History of porphyria (a rare genetic condition affecting blood production)
Severe psychological or psychiatric conditions
Active infection requiring treatment
Immunosuppression (weakened immune system) from any cause
Life expectancy less than 3 months
Known hypersensitivity to study medications

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Verified sites

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Universitaetsklinikum Muenster AöR
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Munster, Germany

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Investigated drugs

5-Aminolevulinic acid (5-ALA) is a naturally occurring compound used in photodynamic therapy. In this trial, it is used as part of radiodynamic therapy for brain tumors. When taken orally, this medication accumulates in cancer cells and becomes activated by radiation, helping to target and destroy tumor cells more effectively. This makes the cancer cells more sensitive to radiation treatment while aiming to minimize damage to surrounding healthy tissue. Radiodynamic therapy (RDT) is a combination treatment that uses both 5-Aminolevulinic acid and radiation therapy. This approach combines the medication with targeted radiation to create a potentially more effective treatment for recurrent glioblastoma, a type of brain cancer.

Aminolevulinic Acid Hydrochloride

What is already known about the treatment

5-Aminolevulinic acid (5-ALA) - An orally administered compound that acts as a prodrug and is converted to protoporphyrin IX in tumor cells, making them fluorescent and more sensitive to light and radiation therapy. This medication is primarily used in the treatment of recurrent glioblastoma, where it serves both as a diagnostic tool for tumor visualization during surgery and as a photosensitizing agent for radiodynamic therapy. In clinical practice, 5-ALA has gained significant attention for its dual role in both tumor detection and treatment enhancement, working at the molecular level by accumulating specifically in cancer cells and enabling targeted therapeutic approaches. This drug belongs to the class of photosensitizing agents and has been extensively studied in neuro-oncology for its ability to improve surgical outcomes and enhance radiation therapy effectiveness.

Investigated diseases

Glioblastoma - A type of brain cancer that forms in the supportive tissue of the brain and typically grows rapidly. It begins with symptoms such as headaches, personality changes, nausea, and seizures. The tumor forms from star-shaped brain cells called astrocytes and can appear in any part of the brain. Glioblastoma often creates increased pressure in the brain as it grows, leading to various neurological symptoms. The tumor can affect different brain functions depending on its location, including movement, speech, thinking, and sensation.