Astroblastoma

Researchers are evaluating the use of Gallium-68-DOTATATE PET/MRI 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 evaluating the safety of avutometinib as a treatment for children and young adults aged 3 to 30 years with advanced or recurrent solid tumor cancers, including pediatric tumors with specific genetic alterations affecting the MAP kinase pathway and certain neurofibromatosis conditions. This phase 1 study aims to find the highest dose of avutometinib that is safe and causes few or mild side effects. Participants receive oral avutometinib twice a week, once daily, in cycles of three weeks on treatment followed by one week off, with each cycle lasting 28 days. The study uses a dose-escalation design, starting at Dose Level 1 and adjusting the dose based on the number of dose-limiting toxicities (DLTs) observed, to identify the maximum tolerated dose (MTD). During the study, participants will be closely monitored for safety over up to 12 months. Researchers will assess side effects and tolerability, and participants will undergo regular evaluations including clinical assessments and laboratory tests. The study carefully tracks adverse events and adjusts dosing to ensure participant safety throughout the trial.

Researchers are evaluating whether mirdametinib is a safe and effective treatment for Central Nervous System tumors, including glioma and neurohistiocytosis. This phase 1/2 trial focuses on patients with MAPK pathway mutant CNS tumors to better understand the drug's 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 2:1 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.

Researchers are evaluating the safety and effects of the study medicine PF-07799544, alone or combined with another medicine called PF-07799933, as a potential treatment for adults with advanced solid tumors that have a BRAF V600 mutation. This clinical trial includes two parts: Phase 1a testing PF-07799544 alone and Phase 1b testing PF-07799544 together with PF-07799933. Phase 1a is closed for enrollment, and Phase 1b focuses on participants with metastatic or recurrent solid tumors, excluding colorectal cancer, who have received prior cancer treatments. In this study, all participants receive both PF-07799544 and PF-07799933 as oral tablets taken twice daily at home. Treatment continues until the cancer stops responding, unacceptable side effects occur, or up to two years, with the option to continue beyond two years. The trial is designed to observe the experiences of participants using these medicines to assess safety and treatment effects. Participants will be monitored through regular assessments including evaluations of side effects, laboratory tests, vital signs, and physical exams from the start of treatment until 28 days after stopping the study drugs. The main measure is to track dose-limiting toxicities within the first 21 days of treatment cycles and overall response rate up to two years. Additional monitoring includes treatment-emergent adverse events, changes in lab results and vital signs, and pharmacokinetics to understand how the drugs behave in the body.

Researchers are evaluating the safety and clinical activity of combining tarlatamab with a fixed dose of metronomic temozolomide in adolescents and adults who have high-grade central nervous system (CNS) tumors. The study involves two phases and includes three groups based on tumor histology: IDH-mutant glioma, other gliomas, and other CNS tumors. Patients must have tumors expressing DLL3, confirmed by immunohistochemistry (IHC) on archival tumor samples, which is done before starting the therapeutic part of the trial. Participants receive tarlatamab intravenously starting with a step dose in the first cycle, followed by regular doses every two weeks. Temozolomide is introduced from the second cycle at a continuous daily dose. The trial has two dose levels with different cycle lengths and dosing schedules. The study groups are non-randomized and open-label, with patients classified by tumor type. During the trial, participants will be assessed for dose-limiting toxicities during the first two cycles and clinical activity over 12 weeks. Researchers will monitor tumor response using iRANO criteria and track progression-free survival, overall survival, and adverse events for up to 12 months. Patients must undergo tumor tissue testing and provide informed consent. The study aims to understand the treatment's safety and effectiveness in controlling disease progression.

Researchers are evaluating a new MRI technique called a gadolinium-weighted sequence to improve the detection of brain metastases in patients undergoing brain scans. The study aims to find out if this novel MRI method can identify more or smaller tumors compared to the standard T1-weighted imaging currently used. The goal is to enhance diagnostic accuracy without increasing the contrast dose or scan time. Participants will have a routine brain MRI with gadolinium contrast, followed by an additional scan using the new gadolinium-weighted MRI sequence during the same session. This new sequence includes advanced features to reduce background signals and better highlight tumors. Both imaging methods will be compared in the same exam to assess their ability to detect brain metastases. During the study, participants will undergo the combined MRI session lasting up to an hour after contrast injection. Researchers will measure the difference in the number of detected brain tumors between the two imaging sequences. The study involves patients known or suspected to have brain metastases and will monitor their ability to lie still during the exam and provide consent. The overall participation involves one MRI visit with no additional contrast or extended scan time.

Researchers are studying entrectinib, a drug approved for treating adult patients with non-small cell lung cancer (NSCLC) that has a ROS1-positive molecular alteration, and for patients aged 12 years and older with solid tumors having specific cancer cell changes. The trial aims to evaluate if entrectinib is effective for other types of cancers with ROS1 gene fusion, including rare adult, pediatric, and teenage/young adult cancers. This study is part of the DETERMINE program, which investigates targeted therapies matched to rare cancer types or specific mutations. Participants in this trial receive entrectinib orally, with dosing based on body surface area (BSA). Adults and pediatric patients with BSA of 1.51 m² or more take 600 mg daily, while those with smaller BSA receive adjusted doses ranging from 100 mg to 400 mg. Each treatment cycle lasts 28 days, and patients continue treatment until disease progression, unacceptable side effects, or withdrawal. Before treatment, patients undergo biopsy and blood sample collection for research, and blood samples are also taken during and at the end of treatment. After treatment, participants are followed every 3 months for 2 years. Throughout the study, patients have regular disease assessments up to 24 weeks from treatment start, including evaluations every two cycles and at the end of treatment. Follow-up visits continue quarterly for up to 2 years. Researchers measure outcomes such as objective response, durable clinical benefit, duration of response, progression-free survival, overall survival, and quality of life through questionnaires. Safety monitoring includes tracking serious adverse reactions and side effects related to entrectinib. The total participation can last several years due to ongoing follow-up and monitoring.

Researchers are investigating the use of amino acid PET combined with MRI to improve the diagnosis and assessment of brain tumors, specifically gliomas and brain metastases. The study aims to overcome limitations of MRI alone in identifying tumor grade, extent, and distinguishing viable tumor tissue from treatment effects or recurrences. Three promising amino acid PET tracers (11C-MET, 18F-FET, and 18F-FACBC) are being evaluated to enhance diagnostic accuracy and treatment planning for these brain conditions. The study includes three substudies: one involving 20 low-grade and 40 high-grade glioma patients examined with 18F-FACBC PET/MRI at baseline and 4-6 months post-surgery, with some also receiving 18F-FET PET/MRI for comparison; another focusing on 30 recurrent high-grade glioma patients undergoing 11C-MET PET/MRI at baseline and one month after Gamma Knife radiosurgery; and a third enrolling patients with brain metastases who will receive amino acid PET/MRI at baseline, one month after surgery or stereotactic radiosurgery, and when recurrence is suspected. Participants will undergo PET/MRI scans at specified time points depending on their diagnosis and treatment plan. Researchers will assess diagnostic accuracy in detecting tumor tissue, differentiate recurrence from treatment-induced changes, and evaluate therapy response. The study monitors patients’ health status and imaging results over several months to improve brain tumor diagnosis and management. Total participation time varies by subgroup and treatment schedule.

Researchers are evaluating the effect of guided meditation during radiation therapy (RT) on acute anxiety in patients with brain tumors. This interventional study aims to compare anxiety changes between participants who receive a mindfulness audio practice during RT and those who receive standard care without intervention. The study focuses on whether mindfulness can reduce anxiety experienced during radiation treatment sessions. Participants will be randomly assigned to either listen to a 5-minute audio-recorded guided meditation during each RT session or receive standard care without this intervention. The meditation includes five validated practices such as body scan, mindful breathing, mindfulness of discomfort, savoring, and loving-kindness. These practices are designed to help patients manage their anxiety and emotional responses during their treatment course. During the 7-week treatment period, participants will be assessed for changes in acute anxiety using a specific anxiety measurement tool based on the GAD-2 scale. Additional assessments include anxiety in daily life and self-transcendence measured by validated questionnaires. Researchers will collect data before, during, and after RT sessions to monitor the impact of the meditation. The study is sponsored by the University of Utah and will help understand if mindfulness practices can support patients undergoing brain tumor radiation therapy.

Researchers are evaluating the HOBSCOTCH-CA program, a home-based intervention designed to improve quality of life and cognitive function in Service Members, Veterans, and civilians who have survived brain cancer or brain tumors. The study also aims to assess how this program might reduce caregiver burden and enhance caregivers' quality of life. The intervention adapts problem-solving therapy to address the cognitive challenges faced by these patients and their caregivers. Participants will be randomly assigned to one of two groups. Group 1 receives the HOBSCOTCH-CA program immediately, while Group 2 waits for three months before starting the intervention. The program includes an initial pre-session and eight weekly sessions conducted virtually, including educational sessions and telephone or webcam follow-ups. Caregivers who choose to enroll receive a tailored version of the program with fewer sessions, focusing on education and mindfulness. Throughout the approximately six-month study, participants will complete questionnaires and surveys at enrollment, three months, and six months. They will also engage in daily diaries on a smartphone app, tracking symptoms, medication adherence, memory strategies, and well-being. Researchers will measure changes in quality of life, cognition, caregiver burden, mood, anxiety, and satisfaction with the program. The study involves regular virtual coaching sessions and continuous monitoring of participants and caregivers.