Choroid Plexus Tumor

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 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 and effectiveness of a modified herpes simplex virus called recombinant oncolytic herpes simplex virus type 1 (R130) in patients with advanced solid tumors. This early phase 1, open, single-arm clinical trial aims to study the treatment in people with various cancers such as sarcoma, carcinoma, digestive cancer, breast cancer, lung cancer, brain cancer, melanoma, gynecologic cancer, head and neck cancer, and kidney cancer. The study focuses on patients who have not responded to standard treatments or who choose not to receive other antitumor therapies. Participants will receive injections of 1 to 2 milliliters of R130 at a concentration of 1x10^8 plaque-forming units per milliliter into their tumors or abdominal cavity every 7 to 14 days. This approach allows the virus to be delivered directly to the cancer site. The study involves only one treatment group receiving the R130 virus, and no placebo or comparison group is used. During the trial, researchers will monitor participants for adverse events and laboratory abnormalities up to 6 months and assess their immune response. Disease control and response duration will be evaluated every 10 weeks for up to 12 months, while quality of life assessments will occur every 6 weeks for the same period. Participants will undergo regular laboratory tests and clinical evaluations to track safety and treatment impact. The total study duration for each participant may extend up to one year with ongoing monitoring.

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 mg/kg 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 mL/kg 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 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 repotrectinib, an oral drug, in pediatric and young adult patients with advanced or metastatic cancers that have specific genetic changes in ALK, ROS1, or NTRK1-3 genes. The study includes two phases: Phase 1 focuses on finding safe dose levels and the recommended dose for children under 12, while Phase 2 assesses the drug's anti-tumor activity in patients aged 12 to 25 with certain gene fusions or alterations. This study aims to address cancers that have progressed despite other treatments or have no standard cure options. In Phase 1, about 12 children under 12 years old with advanced solid tumors or lymphoma will receive different doses of repotrectinib to determine safety and the best dosing. Phase 2 includes three groups of patients aged 12 to 25, with varying genetic profiles and prior treatment histories, all receiving oral repotrectinib. The drug will be given continuously in cycles, with careful monitoring. Enrollment for Phase 1 and Phase 2 occurs simultaneously, allowing younger children to join Phase 2 once their dose is established. Participants will undergo regular assessments including scans and tests to measure tumor response, drug levels in the blood, and side effects. The study tracks several outcomes such as response rate, duration of response, survival, and brain tumor progression over approximately three years. Safety and tolerability are closely monitored during the first 28 days of treatment, with ongoing follow-up visits throughout the study period. This long-term observation helps researchers understand both the drug's effects and patient well-being.

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 a new method to better understand how brain stimulation during awake craniotomies affects hand strength and function in patients with brain tumors invading the primary motor cortex. The study aims to improve the current standard of care, which involves brain surgery with electrical stimulation mapping to avoid permanent neurological damage. Investigators want to develop a standardized way to measure hand movement and explore different stimulation settings to see how they influence motor mapping. Participants will undergo awake craniotomy surgery where additional brain stimulation procedures with varying parameters will be tested beyond the usual care. This will help assess changes in hand strength and movement during the operation. The study focuses on patients with tumors affecting the non-dominant side of the brain's motor cortex. The intervention involves direct electrical stimulation applied during surgery to map motor function. During the study, participants will have their hand strength and function quantitatively measured while surgeons apply different stimulation settings. Researchers will monitor how these parameters interrupt or facilitate hand movement. Data collected will include motor strength assessments and functional tests during surgery to better understand brain stimulation effects. The study includes careful monitoring of neurological function throughout the procedure and will track outcomes related to hand movement during the craniotomy.

Researchers are studying patients with recurrent glioblastoma or progressive high-grade astrocytoma who are scheduled for repeat surgery. This Phase I trial aims to find the highest safe dose of a modified oncolytic adenovirus given with fractionated stereotactic radiosurgery in these patients. The study combines gene therapy with radiation to evaluate potential treatment options for these brain tumors. Participants will receive a single injection of the Ad5-yCD/mutTKSR39rep-ADP adenovirus directly into the tumor area after surgery, at one of three increasing dose levels. This gene therapy is combined with oral medications 5-fluorocytosine and valganciclovir, followed by fractionated stereotactic radiosurgery. Treatment continues until unacceptable side effects, tumor progression, or withdrawal. The study includes a monitoring period before starting any new cancer therapy. During the study, patients will be closely monitored for safety and immune response through blood tests and assessments at multiple time points before and after surgery, up to 90 days. Researchers will measure the maximum tolerated dose and observe changes in immune markers. The study lasts through treatment and follow-up, with a 30-day observation before other therapies begin, ensuring comprehensive safety and response evaluation.