Medulloblastoma

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 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.

Many children with cancer experience emotional distress, fatigue, and difficulties in relationships. Their parents also face increased responsibilities and may feel more distressed and tired. While psychological interventions for these families have shown promise in improving social skills, coping, and well-being, further research is needed. Hypnosis is commonly used in pediatric oncology to reduce pain and distress during procedures and has also been effective in enhancing well-being in adults with cancer. This trial explores the feasibility and potential benefits of combining self-care and hypnosis in a group setting for children with cancer and their parents. The intervention involves six monthly group sessions, each lasting two hours, where participants learn self-hypnosis exercises and discuss self-care techniques like understanding personal needs, self-respect, assertiveness, and managing negative thoughts. Homework assignments are given to encourage positive changes. Two groups participate one including children with cancer and their siblings, and another for their parents. Data are collected before and after the intervention through questionnaires and interviews to assess its impact. Participants will complete assessments measuring changes in childrens quality of life, fatigue related to cancer, and parents perceptions of their childs quality of life and their own fatigue. Secondary outcomes include the impact of cancer on the family, parents emotional distress, and coping strategies. These are evaluated before the program starts and immediately after its conclusion at six months. The study aims to improve understanding of how this combined self-care and hypnosis intervention may enhance the well-being of children with cancer and their families.

Sleep plays a vital role in a childs development, affecting brain function, emotional health, and overall recovery. Children undergoing intensive cancer treatments often experience sleep problems such as difficulty falling or staying asleep, shorter sleep duration, or poor sleep quality. These issues, reported in a significant portion of pediatric cancer survivors, can impact treatment adherence, daily life, and social interactions, highlighting the need for better sleep management in this group. Researchers are evaluating the Dreamcatchers Programme, a nurse-led, multi-component intervention designed to improve sleep quality in children with cancer. The program involves sleep hygiene education, progressive muscle relaxation PMR, and breathing exercises, delivered through group sessions and weekly follow-ups over four weeks. The intervention group receives these targeted strategies, while the control group continues routine hospital support without sleep-specific content, with access to the program after the study. Participants will attend initial education sessions, practice relaxation techniques, and keep sleep diaries to track habits and progress. Nurses will monitor sleep quality and overall life quality at three months using validated tools. Data will be collected securely and confidentiality maintained. This pilot study aims to assess feasibility and provide preliminary effectiveness results to guide future pediatric oncology sleep care.

Researchers are evaluating the use of the drug SGT-53 in combination with radiation therapy and the drug Nivolumab in children with brain tumors that have returned, worsened, or not improved after previous treatments. This early-phase clinical trial aims to find the right dose of SGT-53 that can be safely given alongside radiation and Nivolumab. The study also investigates the side effects of SGT-53, how the drug moves through the body, and how much of it reaches the tumor tissue in a small group of patients. During the first treatment cycle, participants receive SGT-53 twice a week, Nivolumab every two weeks, and radiation therapy during the second week. In cycles two through six, SGT-53 is given once a week during even cycles and twice a week during odd cycles, while Nivolumab continues every two weeks. From cycle seven onward, both SGT-53 and Nivolumab are given every two weeks. In a special early part of the study, four participants will have genetic testing on tumor samples after receiving SGT-53 to compare with skin samples. Participants will be closely monitored throughout the study with evaluations of side effects related to SGT-53 from enrollment to three years after treatment ends. Researchers will assess the drugs safety, how it is processed in the body, and its presence in tumor tissue. The study includes clinical and radiological assessments, genetic testing, and ongoing safety monitoring to understand the treatments effects over time.

Researchers are evaluating CBA-1205, an anti-DLK1 monoclonal antibody, in a first-in-human Phase I study involving patients with advanced solid tumors, hepatocellular carcinoma HCC, malignant melanoma, and pediatric cancers. The study aims to assess the safety and tolerability of CBA-1205 across five parts, including dose escalation and evaluation in different patient groups where standard treatments are unavailable or ineffective. This trial is conducted at multiple centers and is non-randomized and open-label. Participants receive CBA-1205 intravenously at two-week intervals in 28-day cycles. The study includes seven dose cohorts ranging from 0.1 mgkg to 30 mgkg for solid tumors in Part 1, with subsequent parts focusing on specific cancers such as HCC, melanoma, and pediatric cancers. Treatment continues until criteria for discontinuation are met. Pharmacokinetic analysis is also part of the evaluation. During the study, participants will undergo safety monitoring for dose-limiting toxicities and adverse events up to 12 months. Blood samples will be collected to measure serum drug concentration and immunogenicity. Efficacy assessments occur at screening, during treatment cycles, and until treatment discontinuation. Overall, participant involvement includes regular visits for treatment administration and comprehensive monitoring throughout the study duration.

Researchers are evaluating the SYSUCC-RMS regimen for children with rhabdomyosarcoma, a type of pediatric cancer. This study aims to understand how effective and safe this treatment is, while also exploring how combining radiotherapy with chemotherapy affects survival rates across different risk groups low, medium, high, and very high risk. The study is a Phase 3 clinical trial led by Yizhuo Zhang. Participants receive one of several combination chemotherapy regimens based on their risk level low risk patients receive VAC, intermediate risk patients receive VACVII, high risk patients receive CAVIE, and very high risk patients receive CAVVIP. The study follows a single-arm design and evaluates the treatments over various risk groups, focusing on the impact of concurrent therapies on survival. During the study, researchers will monitor participants for up to 10 years, assessing outcomes such as objective response rate, disease control rate, progression-free survival, and overall survival. Safety of the SYSUCC-RMS regimen will also be tracked throughout this period. Participants health status will be regularly evaluated to understand the long-term effects and treatment outcomes.

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 evaluating the safety of 177Lu-DPTA-omburtamab treatment in children and adolescents aged 3 to 21 who have recurrent or resistant brain tumors such as medulloblastoma or cancers that have spread to the central nervous system. This phase 1 study focuses on patients whose tumors express B7-H3 and who have already undergone conventional therapies or have no standard treatment options. The study aims to determine the maximum tolerated dose and monitor any toxicities associated with this treatment. Participants receive one of four escalating doses of 177Lu-DPTA-omburtamab ranging from 25 mCi to 100 mCi, assigned sequentially based on the dose escalation design. The treatment is given in up to two cycles, each lasting 28 days. Patients must have an intraventricular access device and may have active malignancy outside the CNS but without immediate need for systemic treatment. Some patients with systemic and CNS disease receive only one dose, while others with CNS metastases without systemic disease may receive two doses. Throughout the study, participants are closely monitored for toxicities and dose tolerance during treatment cycles. Assessments include performance status evaluations, laboratory tests for kidney and liver function, and monitoring of neurological status. Human Anti-Mouse Antibody testing is performed before treatment. The total duration of active treatment is up to two 28-day cycles, with safety outcomes recorded during this period. The study is conducted by Memorial Sloan Kettering Cancer Center and is expected to complete by July 2030.

Researchers are investigating survival outcomes in children diagnosed with Diffuse Intrinsic Pontine Glioma DIPG, a serious brain tumor with limited treatment options. This study aims to see if using MRI perfusion imaging to classify tumors as hyperperfused or hypoperfused can guide treatment to improve survival. The trial is evaluating whether adding low-dose Bevacizumab to standard radiotherapy or using ultra-low-dose radiotherapy alone affects patient outcomes. Participants with hyperperfused tumors will receive weekly low-dose Bevacizumab alongside conventional radiotherapy over six weeks. Those with hypoperfused tumors will receive an ultra-low-dose radiotherapy regimen designed to match the biological effect of standard treatment but with altered dosing. Both groups follow specific treatment protocols based on MRI perfusion results, with no placebo or randomization involved. During the study, patients will undergo MRI assessments at diagnosis and regular monitoring for survival, disease progression, side effects, steroid use, relapse patterns, treatment adherence, and quality of life. Follow-up evaluations continue for up to 100 months or until disease progression or death. Researchers will primarily measure overall survival with a median target of 12 months from diagnosis to assess the impact of the treatment strategies.