Ongoing Clinical Trials for Brain Tumors
This article provides information about 5 ongoing clinical trials for patients with brain tumors. These studies are being conducted across several countries and are testing different approaches, including surgical aids, antibiotics, neuroprotective medications, fatigue treatments, and combination therapies for resistant tumors. (Also known as: Brain neoplasm)
Clinical trial locations
- Austria
- Denmark
- France
- Germany
- Netherlands
- Sweden
Safety Study of 5-Aminolevulinic Acid for Brain Tumor Surgery in Children and Adolescents
This trial is testing the safety of a medication called 5-Aminolevulinic acid (5-ALA), sold as Gliolan, in children and teenagers undergoing surgery for brain tumors. The medication is taken by mouth before surgery and helps surgeons see tumor tissue more clearly because it makes cancer cells glow pink-red under special blue light during the operation.
Who can participate: Children and adolescents between 3 and 17 years old who have either a newly diagnosed or returning brain tumor that appears on MRI scans. Surgery must be a safe treatment option from a medical perspective. Female participants must not be pregnant or breastfeeding, and sexually active participants must use effective birth control for up to 6 weeks after surgery.
Who cannot participate: Children under 2 years old, patients allergic to 5-ALA, those with severe liver or kidney problems, patients with porphyria (a rare blood disorder), pregnant or breastfeeding women, and those unable to undergo surgery.
Main goal: To determine whether 5-ALA can be safely used in young patients during surgery to help surgeons better identify and remove tumor tissue. The study monitors patients for side effects during and after surgery.
Investigational drug: 5-Aminolevulinic acid (5-ALA) is a naturally occurring compound that accumulates in tumor cells and produces fluorescence under special lighting. This helps doctors distinguish between healthy brain tissue and cancerous tissue during surgery.
Study on Antibiotics Amoxicillin, Clavulanic Acid, Ciprofloxacin, and Drug Combination for Children with Malignant Brain Tumors
This trial studies how different antibiotics move through the body, particularly in the cerebrospinal fluid that surrounds the brain and spinal cord, in children with malignant brain tumors. The study aims to understand how well these medications reach the areas where they might be needed to treat or prevent infections.
Who can participate: Children aged 0 to 18 years with a central nervous system tumor that has spread to the membranes covering the brain and spinal cord, or those at risk of such spread. Participants must be receiving antibiotic treatment either through a vein or by mouth, and must be receiving chemotherapy directly into the spinal fluid through a device called an Ommaya reservoir. Life expectancy must be at least 8 weeks.
Who cannot participate: Patients without a malignant brain tumor or without leptomeningeal spread or risk of spread.
Main goal: To measure how antibiotics concentrate in the cerebrospinal fluid and blood to ensure they are effective and safe for treating infections in children with brain tumors that have spread to the brain’s protective membranes.
Investigational drugs: Various antibiotics including amoxicillin with clavulanic acid, ciprofloxacin, sulfamethoxazole with trimethoprim, cefotaxime, fosfomycin, cefuroxime, ceftriaxone, linezolid, vancomycin, meropenem, and gentamicin.
Study on Lithium Sulphate to Prevent Cognitive Impairment in Children After Brain Tumor Radiotherapy
This trial tests whether lithium sulphate, in a medication called Lithionit, can help prevent thinking and memory problems that may develop after children receive radiotherapy for a brain tumor. The study follows participants for several years with regular cognitive tests and brain scans.
Who can participate: Patients aged 5 to 17 years at the time of radiotherapy who received cranial or craniospinal radiation treatment for a brain tumor within the last 7 years. Participants must use adequate contraception during treatment and for six months after, and must have monthly negative pregnancy tests throughout the study.
Who cannot participate: The exclusion criteria focus on patients without brain tumors, though specific additional exclusions are not detailed.
Main goal: To determine if lithium can protect brain function and prevent processing speed problems that often appear after brain radiotherapy. The study monitors cognitive abilities including thinking, learning, and memory over multiple years.
Investigational drug: Lithium sulphate, taken as prolonged-release tablets. While commonly used to treat mood disorders, this trial explores its potential to protect brain cells from damage after radiotherapy.
Study on Methylphenidate for Reducing Fatigue in Childhood Brain Tumor Survivors
This trial investigates whether methylphenidate, a medication typically used for attention deficit hyperactivity disorder, can help reduce persistent tiredness in people who were treated for brain tumors during childhood or adolescence. The study uses a crossover design where participants receive both the medication and a placebo at different times.
Who can participate: Individuals at least 6 years old who were diagnosed and treated for a brain tumor before age 18, within the last 10 years. Participants must have been off active treatment for at least 12 months with no signs of tumor progression. They must have significant fatigue according to specific questionnaires and speak Danish as their main language.
Who cannot participate: Patients without cancer-related fatigue after treatment, those outside the specified age range, and those not confirmed to have fatigue through screening.
Main goal: To evaluate whether methylphenidate can effectively reduce cancer-related fatigue in survivors of pediatric brain tumors, and to assess its impact on attention, memory, and quality of life.
Investigational drug: Methylphenidate, which works by increasing levels of certain brain chemicals like dopamine and norepinephrine that can help improve attention and energy levels.
Study of Nivolumab with Chemotherapy for Children and Teenagers with Refractory or Relapsing Solid Tumors or Lymphoma
This trial studies combinations of an immune system drug called Nivolumab with different chemotherapy medicines for children and teenagers whose solid tumors or lymphoma have not responded to standard treatments or have returned after treatment. The study uses low-dose, frequent chemotherapy called metronomic chemotherapy.
Who can participate: Patients under 18 years old (or slightly older if diagnosed with pediatric cancer before 18) with solid tumors or lymphoma that are progressive or not responding to treatment. Participants must have a performance status of 70% or higher, adequate organ function, and at least 3 months life expectancy. Sexually active participants must use birth control during treatment and for 6-12 months after.
Who cannot participate: Pregnant or breastfeeding patients, those with severe allergic reactions to study drugs, active infections or serious illnesses, and those who cannot follow study procedures or take medications as required.
Main goal: The first stage determines which chemotherapy combination is safe with Nivolumab. The second stage tests the most promising combination to see how well it prevents cancer from getting worse. The study monitors safety and effectiveness over time.
Investigational drugs: Nivolumab (an immune checkpoint inhibitor that helps the immune system attack cancer cells), Cyclophosphamide (interferes with cancer cell DNA), Vinblastine (disrupts cancer cell division), and Capecitabine (interferes with cancer cell growth when converted to 5-fluorouracil in the body).
Summary
These 5 clinical trials represent diverse approaches to treating brain tumors and managing their complications in children and young people. The trials are geographically concentrated in Northern and Central Europe, with Denmark hosting 2 trials and Germany, Netherlands, Sweden, Austria, and France each hosting 1 trial.
The studies address different aspects of care: surgical visualization, antibiotic distribution, cognitive protection after radiotherapy, fatigue management in survivors, and treatment of resistant tumors. Several trials focus specifically on pediatric populations, reflecting the unique challenges of treating brain tumors in children and adolescents.
Multiple trials involve medications that were originally developed for other conditions, such as lithium for mood disorders and methylphenidate for ADHD, highlighting the exploration of existing drugs for new therapeutic applications. The antibiotic study and the surgical visualization trial both aim to improve existing treatment approaches rather than test entirely new therapies.
