Clinical Trials for Glioblastoma: Current Treatment Research

This article presents information about 38 ongoing clinical trials investigating new treatments for glioblastoma, an aggressive type of brain cancer. These studies are testing various approaches including chemotherapy combinations, immunotherapy, targeted radiation, vaccines, and innovative drug delivery systems in patients with newly diagnosed or recurrent disease.

Clinical trial locations

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

This German study explores radiodynamic therapy combining 5-aminolevulinic acid with radiation treatment for patients whose glioblastoma has returned after initial treatment. The trial aims to determine the highest safe dose of this medication that can be used repeatedly during a four-week radiation therapy course.

To qualify for this trial, patients must be at least 18 years old with confirmed recurrent glioblastoma in the upper brain, having a Karnofsky Performance Score of 60 or higher. Patients need adequate kidney and liver function, normal blood clotting, and for women of childbearing age, a negative pregnancy test within 72 hours of starting treatment. Both men and women must use highly effective contraception during the study and for at least six months afterward.

The study excludes patients who have received brain radiation within the last 12 months, those with other active cancers requiring treatment, pregnant or breastfeeding women, and individuals unable to undergo MRI scans. Patients with serious heart, liver, or kidney problems, severe psychological conditions, or a history of porphyria cannot participate.

The treatment involves taking Gliolan oral solution combined with radiation therapy sessions over four weeks. The main goal is assessing safety and tolerability while monitoring for side effects, particularly neurological and skin reactions. Participants must use contraception during treatment and for specified periods afterward, and avoid sun exposure due to potential skin sensitivity to light.

Study of Debio 0123 and Temozolomide for Adults with Recurrent or Newly Diagnosed Glioblastoma

This Spanish clinical trial investigates Debio 0123 combined with temozolomide, and in some cases radiotherapy, for both newly diagnosed and recurrent glioblastoma. The study aims to determine the safest dose and evaluate how effective this combination is compared to standard treatment options.

Patients must be 18 or older and provide written consent. For those with recurrent disease, participants can have had up to two previous treatments, with documented disease progression confirmed by MRI or biopsy. Newly diagnosed patients must have a Karnofsky Performance Score of 70 or higher, while recurrent disease patients need a score of 60 or higher. All participants must have adequate bone marrow, liver, and kidney function, a life expectancy of at least three months, and stable or decreasing corticosteroid doses.

The trial excludes patients with other active cancers, serious heart problems, uncontrolled high blood pressure, severe liver or kidney disease, those who are pregnant or breastfeeding, and individuals who have had major surgery within four weeks. Patients currently in other clinical trials or with known allergies to study drugs are also excluded.

Debio 0123 works by targeting specific pathways in cancer cells to inhibit their growth and survival. Participants undergo regular assessments including blood tests and MRI scans to monitor treatment response and safety. The study will gather important data on progression-free survival and quality of life measures.

Study of Itraconazole with Radiotherapy and Temozolomide for Patients with Newly Diagnosed Glioblastoma

This German trial tests whether itraconazole, an antifungal medication, can enhance standard treatment for newly diagnosed glioblastoma when combined with radiotherapy and temozolomide. The study aims to find the maximum safe dose of itraconazole that can be given with these standard treatments.

Eligible participants must have a confirmed histological diagnosis of new glioblastoma with no previous treatments except surgery. They must be able to undergo MRI scans and receive standard radiation therapy. Participants need to be at least 18 years old with an ECOG performance status of 2 or less, meaning they can take care of themselves but may be unable to work. The time between first surgery or biopsy and radiation therapy start must be less than 43 days.

The trial excludes patients under 18 or over 65 years old, those who are not adults, and individuals unable to follow study procedures or take oral medications. Itraconazole is administered as hard capsules by mouth, while standard radiotherapy delivers 60 Gy in 30 fractions. Participants also receive temozolomide as part of the standard treatment protocol. Throughout the study, regular MRI scans and check-ups monitor treatment effectiveness and safety.

Study of Meclofenamate Sodium and Temozolomide for Patients with Progressive MGMT-Methylated Glioblastoma

This German study investigates adding meclofenamate sodium to standard temozolomide treatment for patients with glioblastoma that has progressed after initial treatment. The study has two phases: first determining the safe dose of meclofenamate sodium, then evaluating how well this combination works.

Patients must have experienced their first tumor recurrence more than three months after finishing chemotherapy and more than six months since completing radiation therapy, with no new treatment started yet. The tumor must show growth according to RANO criteria. Participants need a confirmed diagnosis through tissue examination showing MGMT promoter methylation and IDH wildtype features. They must be over 18 years old with a Karnofsky performance score of 60 percent or higher, have a life expectancy exceeding six months, and possess adequate blood counts, liver function, and kidney function.

Patients are monitored over 56 days for any dose-limiting side effects, with regular MRI scans to assess tumor progression. Both medications are taken orally as capsules. Throughout the trial, researchers track progression-free survival measured from the study start until disease progression is detected. The study also evaluates overall survival, quality of life, and cognitive function using the Karnofsky performance score and Mini Mental State Examination.

Study of Pembrolizumab Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme Patients

This Polish trial evaluates adding pembrolizumab immunotherapy to standard treatment for newly diagnosed glioblastoma. Pembrolizumab is given as an intravenous infusion at 200 milligrams per treatment session, both before and after the standard Stupp protocol which includes surgery, radiation therapy, and chemotherapy.

Participants must be between 18 and 70 years old with confirmed glioblastoma diagnosis through brain scans. The tumor must be in a location where surgery is possible, and patients need a Karnofsky score of 80 or higher, meaning they can carry out normal activities with minimal symptoms. Life expectancy must be at least three months. Women who can become pregnant must agree to either remain abstinent or use double barrier contraception during treatment and for 120 days after the last scan. Men must also use effective barrier contraception during this period if sexually active with women of childbearing potential.

The study excludes patients with autoimmune diseases requiring systemic treatment in the past two years, active hepatitis B or C, HIV infection, previous treatment with immune checkpoint inhibitors, uncontrolled high blood pressure, serious heart conditions, active infections, or other active cancers. Regular MRI scans, blood tests, and clinical assessments monitor treatment response and safety throughout the study period.

Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

This French trial tests a vaccine approach using three different injection solutions: Peptide A49 associated with melanin, Peptide A52 associated with melanin, and Litenimod solution. The vaccine is designed to stimulate the immune system to fight glioblastoma more effectively through subcutaneous injections.

Eligible participants must be between 18 and 75 years old with adequate organ function. They must have a newly diagnosed glioblastoma with methylated MGMT promoter, confirmed by local testing, and be HLA-A2 positive with PTPRZ1 expression in the tumor. Patients need to have completed radiation therapy and temozolomide treatment 28 to 45 days before starting the study treatment. A Karnofsky Performance Status of 60 percent or higher is required, along with a life expectancy of at least three months.

The trial evaluates safety at multiple time points throughout the first year, including Day 0, Week 2, Week 4, Week 6, and monthly intervals thereafter. Cerebral MRI scans are conducted at the start, Month 2, Month 3, and every two months following. The immune response is assessed by measuring specific T cell responses in the blood using IFN-gamma ELISPOT testing at various intervals. Quality of life is evaluated using specific questionnaires at the beginning and at five months. Both men and women who can have children must use effective birth control during the study and for specified periods after treatment ends.

Study on Adding Zoledronic Acid to Standard Treatment for Patients with Glioblastoma

This Latvian study evaluates whether adding zoledronic acid to standard glioblastoma treatment can improve patient outcomes. Zoledronic acid, known for strengthening bones and treating high calcium levels in cancer patients, is being explored for potential benefits beyond bone health in treating brain cancer.

Participants must be 18 years or older, able to provide signed informed consent and agree to follow study requirements. They must have IDH negative glioblastoma with confirmed diagnosis, having completed prior treatments including surgery or biopsy and radio-chemotherapy, with at least 28 days since last treatment. Adequate organ function is required, including white blood cell count higher than 1×10^9/L, platelet count higher than 100×10^9/L, liver enzymes less than three times the upper normal limit, hemoglobin level higher than 80 g/L, and kidney function with creatinine clearance more than 60 mL/min.

Participants are randomly assigned to receive either standard therapy alone or standard therapy with zoledronic acid. The medication is administered as Zometa 4 mg/100 ml solution through intravenous infusion, with frequency determined by the study protocol. Regular monitoring assesses overall survival, progression-free survival, and any adverse effects. Women of childbearing potential must have negative pregnancy tests and agree to remain abstinent or use effective contraception during the study and for 90 days after the last dose. Men must also agree to remain abstinent or use condoms during this period.

Study on Bevacizumab for Patients with Newly Diagnosed IDH Wild-Type, MGMT Unmethylated Glioblastoma

This German trial investigates combining bevacizumab with radiochemotherapy for newly diagnosed IDH wild-type, MGMT unmethylated glioblastoma. Bevacizumab works by inhibiting VEGF, a protein involved in forming new blood vessels that tumors need to grow, potentially improving treatment effectiveness by cutting off the tumor’s blood supply.

Patients must have confirmed glioblastoma diagnosis with specific tumor characteristics shown by tests, and MRI images taken within two weeks before starting radiation therapy. Age must be between 18 and 70 years, with an ECOG Performance Status of 0 to 2. Women who can become pregnant must not be breastfeeding and must have negative pregnancy tests within seven days before starting treatment. Both men and women must use highly effective birth control during the study and for six months after.

The trial excludes patients with other active cancers, serious heart problems, uncontrolled high blood pressure, severe liver or kidney disease, those who are pregnant or breastfeeding, and individuals who have had major surgery within four weeks. Bevacizumab is administered intravenously at a concentration of 25 mg/ml, with specific dosage and frequency determined by healthcare providers. Radiotherapy is adjusted to achieve isotoxic dose escalation. Throughout the trial, patients undergo regular MRI scans and health assessments to evaluate treatment response, safety, and tolerability.

Study on Early Temozolomide Treatment for Adults with Glioblastoma

This French study evaluates whether starting temozolomide treatment earlier than usual can improve overall survival in adults with newly diagnosed glioblastoma. Participants are randomly assigned to receive either early treatment with temozolomide or the standard treatment protocol, with treatment beginning within 15 days after surgery or biopsy.

Patients must be 18 years or older with a histologically confirmed new glioblastoma diagnosis. They need adequate biological functions including sufficient white blood cells, platelets, normal kidney and liver function. A Karnofsky performance status of 60 percent or higher is required, with the understanding that scores below 60 should only be due to tumor-caused weakness. Any side effects from previous treatments should be mild, except for hair loss, nausea, vomiting, and neurological symptoms.

The trial excludes patients with other types of brain tumors besides de novo glioblastoma, those under 18 years old, individuals unable to follow study procedures, pregnant or breastfeeding women, and those with serious health conditions that might interfere with the study. Temozolomide is taken orally at 150-200 mg per square meter of body surface area daily for five days, followed by a 23-day rest period. Standard radiation therapy consists of 60 Gy delivered in 30 fractions. Regular monitoring tracks overall survival, progression-free survival, and quality-adjusted time without symptoms or adverse events.

Study on Gemcitabine for Patients with Recurrent Glioblastoma

This Norwegian trial explores an Individualized Systems Medicine approach for recurrent glioblastoma. The study tests tumor cells with various drugs to find the most effective treatment for each patient’s specific cancer, targeting cancer stem cells believed responsible for tumor growth and recurrence.

Participants must be between 18 and 70 years old with histologically verified glioblastoma and be ambulatory with an ECOG performance status of 0-1, meaning they can walk and carry out daily activities without help or with minimal symptoms. They must have experienced their first disease return after initial treatment with radiation therapy and chemotherapy, with more than three months since last chemotherapy and more than six months since radiation therapy ended. Adequate bone marrow, liver, and heart function are required.

Tumor tissue is used to produce a personalized treatment plan through high-throughput drug screening of tumor cells. Gemcitabine is administered as a solution for infusion directly into the bloodstream, with dosage and frequency determined by the healthcare team based on screening results. Throughout the study, tumor size and response are monitored through regular assessments. Overall survival and response to treatment are evaluated and compared to specific tumor characteristics. The study aims to complete by February 2026.

Summary

This comprehensive overview of 38 ongoing clinical trials reveals the diverse and innovative approaches being pursued to improve outcomes for glioblastoma patients. The trials span 17 countries across Europe, with the highest concentration in France and Germany, reflecting these nations’ strong commitment to neuro-oncology research.

Several notable patterns emerge from these studies. A significant number of trials focus on combination therapies, particularly adding novel agents to the standard temozolomide and radiotherapy regimen. Immunotherapy approaches feature prominently, with multiple trials testing dendritic cell vaccines, checkpoint inhibitors like pembrolizumab and nivolumab, and personalized vaccine strategies. Innovative drug delivery methods are also under investigation, including ultrasound-assisted blood-brain barrier disruption and photodynamic therapy techniques.

The trials address both newly diagnosed and recurrent disease, with particular attention to molecular subtypes such as MGMT methylation status and IDH mutation status. This precision medicine approach reflects growing understanding that glioblastoma is not a single disease but comprises distinct molecular entities requiring tailored treatment strategies.

Many studies incorporate quality of life assessments and neurocognitive function evaluations alongside traditional survival endpoints, acknowledging the importance of maintaining patient wellbeing during treatment. The inclusion of both adult and pediatric populations in some trials demonstrates commitment to addressing this disease across all age groups.

While these trials offer hope for improved treatments, patients should discuss participation with their medical teams to determine which studies might be appropriate for their specific situation.

#1 Clinical Trials Search in Europe

Glioblastoma – Trials in Disease

Clinical Trials for Glioblastoma: Current Treatment Research

Clinical trial locations

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

Study of Debio 0123 and Temozolomide for Adults with Recurrent or Newly Diagnosed Glioblastoma

Study of Itraconazole with Radiotherapy and Temozolomide for Patients with Newly Diagnosed Glioblastoma

Study of Meclofenamate Sodium and Temozolomide for Patients with Progressive MGMT-Methylated Glioblastoma

Study of Pembrolizumab Combined with Standard Chemo-Radiotherapy for Newly Diagnosed Glioblastoma Multiforme Patients

Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

Study on Adding Zoledronic Acid to Standard Treatment for Patients with Glioblastoma

Study on Bevacizumab for Patients with Newly Diagnosed IDH Wild-Type, MGMT Unmethylated Glioblastoma

Study on Early Temozolomide Treatment for Adults with Glioblastoma

Study on Gemcitabine for Patients with Recurrent Glioblastoma

Summary

Ongoing Clinical Trials on Glioblastoma

Study of iodofalan (131I) and lomustine combination therapy compared to lomustine alone in patients with first recurrent glioblastoma

Study on the Effectiveness of Optune with Temozolomide and Pembrolizumab in Patients with Newly Diagnosed Glioblastoma

Study on Adding Zoledronic Acid to Standard Treatment for Patients with Glioblastoma

Study of Itraconazole with Radiotherapy and Temozolomide for Patients with Newly Diagnosed Glioblastoma

Study on the Use of Metformin in Addition to Standard Treatment for Patients with Glioblastoma

Study on A49, A52, and Litenimod Sodium for Patients with Glioblastoma

Study on the Effects of Dendritic Cell Immunotherapy and Temozolomide in Patients with Glioblastoma

Title: Study of ultrasound-assisted carboplatin therapy with SonoVue for children with recurrent malignant brain tumors using blood-brain barrier disruption

Study on the Safety and Effectiveness of Nivolumab, Ipilimumab, and Myeloid Dendritic Cells for Patients with Recurrent Glioblastoma After Surgery

Study on Lomustine with or without Additional Brain Radiation for Patients with Recurrent Glioblastoma

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Glioblastoma – Trials in Disease

Clinical Trials for Glioblastoma: Current Treatment Research

Clinical trial locations

Summary

Ongoing Clinical Trials on Glioblastoma

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