Oligodendroglioma

Researchers are evaluating the use of 18F-Fluciclovine positron emission tomography PET as a biomarker to measure the response or progression of brain metastasis in participants treated with stereotactic radiosurgery SRS. This pilot imaging study focuses on adults diagnosed with brain metastases who are planned to receive SRS treatment. The study is sponsored by Baptist Health South Florida and is a Phase 1 clinical trial. Participants will undergo an 18F-fluciclovine PET scan at the time of their SRS planning magnetic resonance imaging MRI. They will then receive a single dose of SRS as part of their standard care. A second 18F-fluciclovine PET scan will be performed approximately 8 weeks after the SRS treatment, with a window of plus or minus 2 weeks. During PET scans, participants receive a 5-mCi dose of 18F-fluciclovine through intravenous injection, with imaging data collected up to 25 minutes post-injection. Throughout the study, participants will be monitored using PET imaging to evaluate changes in standardized uptake values SUV over 8 weeks, which helps assess tumor response. Tumor control will also be evaluated at 12 months. The study involves standard imaging, including MRI and PET scans, and tracks participant safety and treatment progress. Total participation timelines include initial scans at SRS planning and follow-up imaging about 8 weeks later, with tumor control assessed after one year.

Researchers are evaluating whether 18F-fluciclovine Axumin PET imaging can help doctors distinguish between true tumor growth and other changes in children with high-grade gliomas, including diffuse midline glioma. This distinction is important because true tumor progression may require a change in treatment, while post-treatment changes usually do not. Conventional MRI scans cannot reliably make this differentiation, so this study aims to see if 18F-fluciclovine PET imaging can serve as a useful diagnostic tool. Participants will receive a single intravenous injection of 18F-fluciclovine before undergoing a combined PET-MRI scan. This imaging process is designed to assess tumor status by detecting physiological changes. The study focuses on children and young adults aged 1 to under 21 years with measurable high-grade gliomas or diffuse midline gliomas. The study is an early phase 1 trial, and treatment involves only this one-time imaging procedure. During the study, researchers will analyze the imaging results and compare them to histopathology findings within four weeks and evaluate safety over six months. Participants will be monitored for any side effects related to the imaging agent. The study will assess the usefulness and safety of 18F-fluciclovine PET-MRI in guiding treatment decisions for pediatric high-grade glioma. Participation lasts through these assessments, with imaging and follow-up evaluations scheduled accordingly.

Researchers are evaluating the use of Gallium-68-DOTATATE PETMRI in patients with somatostatin receptor-positive SSTR-positive central nervous system CNS tumors, mainly focusing on meningioma but also including other tumor types such as esthesioneuroblastoma, hemangioblastoma, medulloblastoma, paraganglioma, pituitary adenoma, and SSTR-positive systemic cancers metastatic to the brain. The study aims to assess the diagnostic usefulness of this imaging technique, especially in distinguishing tumor recurrence from post-treatment changes, with a particular interest in cases where tumor location limits surgical removal or where patients have higher-grade disease or previous radiation treatment. This is a Phase 4 interventional study sponsored by Weill Medical College of Cornell University.

Researchers are investigating treatments for oligodendrogliomas, a type of brain tumor classified by specific genetic markers including mutations in isocitrate dehydrogenase IDH and co-deletion of chromosomes 1p19q. This trial focuses on adults with newly diagnosed grade 2 or 3 gliomas, aiming to improve survival without loss of brain function, cognition, or quality of life. The study compares two treatment approaches to determine the best timing and combination of chemotherapy and radiotherapy. Participants are randomly assigned to receive either standard chemoradiation with procarbazine, CCNU lomustine, and vincristine PCV combined with radiotherapy, or an experimental approach starting with chemotherapy using lomustine and temozolomide CETEG followed by radiotherapy and PCV at tumor progression. Radiotherapy is delivered over about 5 to 6 weeks, with doses adjusted for tumor grade. Chemotherapy cycles last 6 weeks and include specified doses of oral and intravenous drugs. During the study, participants undergo regular magnetic resonance imaging MRI scans every three months, neurological assessments, quality of life questionnaires, and cognitive testing annually. The main outcome measured is qualified overall survival, which tracks survival without significant cognitive or functional decline. The study lasts up to 10 years, with ongoing monitoring of tumor progression, treatment response, and patient wellbeing. Safety and side effects are carefully assessed throughout the trial.

Researchers are studying high-grade and low-grade gliomas to better understand why these brain tumors behave differently within and between patients and why current treatments often fail. This research aims to uncover how gliomas become more aggressive, spread, and resist therapies by using patient-derived organoids PDOs, which are three-dimensional tumor cultures grown from patients tumor tissue. The ultimate goal is to develop personalized tumor models to test new treatments that could improve survival and quality of life for glioma patients. The study involves collecting tumor tissue from patients diagnosed with either low-grade or high-grade glioma who are scheduled for tumor removal surgery. The tissue will be used to grow PDOs that closely resemble the original tumors. Researchers will analyze these organoids for their genetic, epigenetic, and cellular characteristics and test how they respond to standard and new treatments, including chemotherapy, immunotherapy, and radiation with photons or protons. Additionally, the study will explore interactions between tumor organoids and immune cells, as well as mechanisms of tumor cell death and progression. Participants will undergo tumor resection and blood sampling at baseline to provide tissue for organoid creation and analysis. The research team will monitor the phenotypic and molecular profiles of the organoids to understand tumor behavior and treatment response. This observational study does not involve experimental treatments for participants. Participation involves providing tumor tissue during planned surgery, with no additional treatment changes. The study will continue until December 2028, focusing on advancing knowledge to guide future glioma therapies.

Researchers are evaluating the safety and effectiveness of a combination treatment using ivosidenib, venetoclax, and azacitidine in adult Chinese patients newly diagnosed with IDH1 mutation acute myeloid leukemia AML. This phase 2, single-arm, open-label trial involves about 42 participants across multiple centers in China. The study aims to measure how well this combination induces complete remission and partial hematologic recovery, along with other outcomes like event-free survival and overall survival. Participants receive combination therapy in two groups those considered fit and those unfit for intensive treatment. Ivosidenib is taken orally daily starting from day 15 of the first 28-day cycle and continues daily thereafter. Venetoclax is given orally with a dose escalation in the first cycle and then daily for 14 days of each subsequent cycle. Azacitidine is administered by injection daily for seven days in each 28-day cycle. Fit participants undergo at least 2 cycles, while unfit participants receive a minimum of 6 cycles unless certain conditions like relapse, disease progression, unacceptable side effects, pregnancy, withdrawal, or study completion occur. Throughout the trial, participants will be monitored regularly to assess treatment response, including complete remission rates at one year, event-free survival, overall survival, and objective response rates. Blood and bone marrow samples will be collected periodically. Participants will also complete quality of life assessments during and after treatment. The study includes safety monitoring and requires informed consent, with careful follow-up to evaluate the treatments effects over time.

Researchers are investigating the safety and effectiveness of Bevacizumab BEV with or without microbubble-mediated focused ultrasound FUS using the NaviFUS System in patients with recurrent glioblastoma multiforme rGBM. This pivotal, randomized, open-label study compares standard care BEV alone to BEV combined with FUS in patients who have previously undergone surgery, radiotherapy, and chemotherapy with temozolomide. BEV is considered the best current treatment choice for these patients after prior therapies. Participants will be randomly assigned to one of two groups. One group will receive BEV alone via intravenous infusion at a dose of 10 mgkg over 30-90 minutes every two weeks. The other group will receive the same BEV treatment followed by administration of microbubbles SonoVue at 0.1 mLkg and focused ultrasound exposure controlled by the NaviFUS System. Treatments will continue every two weeks for up to 34 weeks or until disease progression, intolerable side effects, non-compliance, or withdrawal. During the study, participants will be monitored through regular assessments including MRI scans, quality of life questionnaires, cognitive tests Mini-Mental State Examination, and evaluation of corticosteroid use and adverse events. The primary outcome is progression-free survival at six months. Secondary outcomes include survival rates up to two years, tumor response, local disease control, and performance status. The total study participation can last up to 36 months with ongoing safety and efficacy monitoring.

Researchers are studying patients with 1p19q-codeleted low-grade oligodendrogliomas who have been treated with radiotherapy plus PCV chemotherapy. The study aims to evaluate whether delaying radiotherapy until tumor progression can reduce the risk of neurocognitive decline without affecting overall survival. This is a phase 3 randomized trial sponsored by Hospices Civils de Lyon, focusing on preserving brain function while managing tumor growth. Participants are randomly assigned to one of two treatment groups one group receives six cycles of PCV chemotherapy alone, and the other group receives radiotherapy followed by six cycles of PCV chemotherapy. Radiotherapy delivers 50.4 Gy in 28 sessions using IMRT technique. PCV chemotherapy includes a cycle with CCNU orally on day 1, vincristine intravenously on days 8 and 29, and procarbazine orally from days 8 to 21. Treatment cycles are repeated six times. During the study, participants will undergo neurocognitive examinations and quality of life assessments. Researchers will monitor survival without neurocognitive deterioration over nine years, along with progression-free survival and overall survival. Laboratory tests and physical evaluations will be conducted before and during the study. The trial includes detailed follow-up to assess the long-term effects of the treatments on cognition and tumor control.

Diffuse gliomas are common brain tumors often treated with surgery followed by radiation and chemotherapy. Radiation therapy helps target tumor cells but can also harm healthy brain tissue, causing a side effect called radionecrosis RN. RN may appear without symptoms or cause new symptoms such as headaches, weakness, or seizures. This phase 2 study evaluates the ability of the drug Chlorophyllin to treat brain radionecrosis in patients with diffuse glioma. The study is funded by the Bhabha Atomic Research Centre and aims to assess clinical and radiological responses over two years. Participants receive Chlorophyllin, a water-soluble compound derived from chlorophyll, known for its anti-inflammatory, antioxidant, and other health properties. This study includes two groups patients with symptomatic RN who also receive steroids, and patients with asymptomatic RN who are neurologically stable. The trial measures response rates at one month and continues follow-up for three months, with an expected enrollment of about 118 patients. Throughout the study, patients undergo clinical and radiological assessments to monitor treatment effects and safety. Researchers track response rates at one and three months, survival at three months, and health-related quality of life. The study lasts about three months per patient, with overall study duration of two years. Monitoring includes evaluating neurological status, imaging findings, and questionnaires to assess outcomes and side effects.

Researchers are evaluating whether mirdametinib is a safe and effective treatment for Central Nervous System tumors, including glioma and neurohistiocytosis. This phase 12 trial focuses on patients with MAPK pathway mutant CNS tumors to better understand the drugs impact on these conditions. The study is sponsored by Memorial Sloan Kettering Cancer Center and aims to measure the best overall neurologic response rate within one year. Participants are divided into two main groups. Eleven patients with refractory neurohistiocytosis will receive continuous cycles of mirdametinib. Meanwhile, 30 participants with recurrent NF1-mutant glioma will be randomized in a 21 ratio to either receive perioperative mirdametinib for five days before surgery or no drug before surgery. After surgery, all glioma participants will take mirdametinib twice daily continuously until disease progression or clinical changes occur. During the study, participants will undergo regular evaluations including neurological assessments and monitoring of disease progression via imaging scans. Researchers will collect data on safety, tolerability, and treatment response. The study includes scheduled visits, laboratory tests, and performance status assessments. Participation will continue until disease progression or other criteria require stopping treatment, with ongoing monitoring throughout the trial period.