Ewing Sarcoma

Researchers are evaluating a new PET imaging tracer called 18FFAPI-74 to detect cancer by targeting the fibroblast-activation protein FAP found in cancer-associated fibroblasts. This study aims to compare 18FFAPI-74 PET scans to the standard 18F-FDG PET scans and other imaging methods like CT or MRI across several cancers including pancreatic ductal adenocarcinoma, cholangiocarcinoma, hepatocellular carcinoma, gastric, bladder, ovarian cancers, pheochromocytomaparaganglioma, small cell lung cancer, neuroendocrine cancer, mesothelioma, and sarcoma. The study is a phase 2 interventional trial conducted by the National Cancer Institute NCI. Participants will receive an intravenous dose of 18FFAPI-74 before undergoing PETCT imaging about one hour later. They will also have a baseline FDG PET scan within one week. If tumors are detected by 18FFAPI-74, additional scans using this tracer and FDG may be repeated during routine treatment and if cancer progresses within two years. Those with negative baseline 18FFAPI-74 scans will not have repeated scans but remain in follow-up. The study involves a single arm where participants undergo both types of PET imaging. During the study, participants will have scans at baseline and potentially at subsequent treatment or progression points. Safety monitoring includes observation for reactions to the tracer up to three days after injection. Researchers will measure the mean number of lesions, standardized uptake values at baseline, post-treatment, and recurrence. Follow-up calls will continue for two years to assess progression-free survival and overall survival. The total participation duration includes imaging visits and two years of follow-up monitoring.

Researchers are evaluating the imaging agent 64Cu-LNTH-1363S in patients with sarcomas or gastrointestinal tract GIT cancers to assess its safety, determine the best imaging dose and timing, and compare the imaging results with fibroblast activation protein FAP expression in tumor samples. This Phase 12a open-label study is divided into two parts and aims to better understand how this radiolabeled agent behaves in the body and how well it highlights tumors that express FAP. In Part 1, six patients with metastatic sarcomas will receive a fixed dose of 64Cu-LNTH-1363S to evaluate its distribution, radiation dose, and optimal imaging window during a one-day intervention, followed by a safety follow-up. In Part 2, approximately 20 patients with non-metastatic, operable sarcomas or GIT cancers scheduled for surgery will receive the optimal dose determined in Part 1 to study the correlation between imaging results and tissue FAP expression. Both parts include detailed cardiac monitoring to assess any changes in heart activity related to the agent. Participants will undergo screening before receiving the imaging agent, followed by serial PETCT scans at multiple timepoints on the intervention day to measure biodistribution and image quality. Tissue samples collected during surgery will be analyzed to compare with imaging findings. Safety and tolerability will be monitored through follow-up visits, ECGs, and phone contact. The total study duration varies from about three weeks for Part 1 to up to 11 weeks for Part 2, including surgery and post-surgery sample collection.

Researchers are studying the safety and initial effects of T3011, given directly into tumors, alone and combined with the intravenous drug pembrolizumab. This Phase 12a open-label study focuses on adults with advanced or metastatic solid tumors, including melanoma, head and neck squamous cell carcinoma HNSCC, sarcoma, cutaneous squamous cell carcinoma cSCC, and non-small cell lung cancer NSCLC. The study aims to find safe dose levels and assess how well these treatments are tolerated and work in these cancer types. The study involves several groups Phase 1 tests increasing doses of T3011 alone to determine a recommended dose. Phase 2a Part 1 evaluates T3011 alone in participants with melanoma, HNSCC, sarcoma, and cSCC. Phase 2a Part 2 studies T3011 with pembrolizumab in NSCLC patients. A rollover arm allows participants whose cancer progresses on T3011 alone to receive the combination treatment. T3011 is given as an intratumoral injection every two weeks, and pembrolizumab is given intravenously every three weeks when combined. Participants will have tumor biopsies, imaging, and laboratory tests to monitor safety, drug levels, and cancer response. Researchers will track side effects and measure outcomes like tumor response and survival for up to two years after the first dose. Safety and tolerability are closely followed throughout, with additional monitoring for immune responses and drug presence in bodily fluids. Participants may be followed for up to one year after their last treatment dose to assess overall survival and long-term effects.

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 investigating the drug OKN4395, alone and combined with pembrolizumab, in adults with advanced solid tumors. This Phase 1 study aims to assess the safety, tolerability, blood levels, and anti-tumor activity of OKN4395 both as a single treatment and alongside pembrolizumab. The study focuses on tumors with a COX2-associated immunosuppressive pathway and includes multiple cancer types such as sarcoma, non-small cell lung cancer, colorectal cancer, and gastric cancer. The study is divided into two main parts. Part 1a includes dose escalation of OKN4395 alone or with pembrolizumab every 21 days, increasing doses based on safety evaluations, and a substudy testing how food and stomach acid affect OKN4395 blood levels. Part 1b evaluates OKN4395 alone or combined with pembrolizumab in four cancer cohorts. Participants receive oral OKN4395 twice daily, with pembrolizumab given intravenously every three weeks where applicable. The substudy involves dosing under fasting, fed, and high stomach pH conditions using famotidine. Participants will be monitored through regular visits lasting up to 27 months for Part 1a and up to 12 months for Part 1b. Assessments include safety checks for side effects, blood tests for drug levels and lab abnormalities, ECGs, tumor measurements, and evaluation of treatment response and progression. The study tracks dose adjustments, adverse events, and survival outcomes to understand the drugs effects and tolerability in solid tumor patients.

Researchers are evaluating ST-01156, an oral small molecule that degrades RBM39, in patients with advanced solid tumors, including Ewing Sarcoma, hepatocellular carcinoma, and biliary tract cancer. This Phase 11b study aims to assess the safety, tolerability, pharmacokinetics, and preliminary anticancer activity of ST-01156. The trial also seeks to find the maximum tolerated dose and recommended Phase 2 dose for this treatment. The study is conducted in two parts, with Part 1 focusing on dose escalation. Participants will receive ST-01156 orally once daily for 5 consecutive days followed by 2 days without treatment each week. The dose will be gradually increased to evaluate safety and determine the best dose for further study. During the trial, participants will undergo regular assessments including evaluation of tumor lesions using RECIST v1.1 criteria and monitoring of organ function and performance status. Researchers will monitor safety and treatment effects during the first 28 days and throughout the treatment period. Follow-up exams will continue every 6 weeks until disease progression or treatment discontinuation. Participants may be followed for up to several years to assess long-term outcomes and adverse effects.

Researchers are conducting an open, single-arm Phase I clinical trial to evaluate the safety, tolerability, viral distribution, shedding patterns, pharmacodynamics, immunogenicity, and initial antitumor effects of the GC001 oncolytic vaccinia virus injection in patients with advanced solid tumors. The study aims to identify dose-limiting toxicities, maximum tolerated dose, or maximum administered dose of the treatment in this population. This trial includes patients with various advanced solid tumors for which standard treatments are ineffective or unavailable. The study involves a dose escalation design with up to six dose groups ranging from 3 x 106 to 1 x 109 plaque-forming units PFU. Each participant receives a single intratumoral injection of GC001, up to 4 mL based on lesion size, targeting up to two measurable extracranial lesions. A Safety Monitoring Committee oversees dose escalation decisions based on safety, tolerability, and preliminary efficacy data. The study carefully monitors viral biodistribution, shedding, pharmacodynamics, and immune responses alongside antitumor activity. Participants will be observed closely for 28 days post-injection to assess safety and dose-limiting toxicities. Follow-up includes evaluations of tumor response, duration of response, and progression-free survival for up to two years. Assessments include imaging scans, viral monitoring, and immunologic tests. The study also includes ongoing safety monitoring, with adjustments to dosing, administration schedules, and biospecimen collection times as needed. Total participation duration varies based on individual follow-up requirements.

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.