Bone 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.

Researchers are evaluating a new T-cell membrane-anchored tumor targeted IL12 attIL12-T cell therapy combined with cyclophosphamide in patients with advanced or metastatic soft tissue or bone sarcomas. This phase 1 trial aims to find the best dose for treatment and to understand the safety, tolerability, and early signs of disease control, especially in patients with recurrent unresectable osteosarcoma. The study also explores immune responses and tumor cell changes related to the therapy. Participants will receive attIL12-T cell therapy combined with cyclophosphamide administered intravenously. The study includes two parts Part A focuses on finding the safe and recommended dose, starting with the lowest dose, while Part B involves treating patients with osteosarcoma at the recommended dose found in Part A. Treatment schedules depend on the participants group and study phase. During the trial, participants will undergo tumor biopsies when possible and provide blood samples to assess immune changes. Researchers will monitor adverse events to evaluate safety for about one year. The main measurement is the incidence of side effects, and disease control will also be assessed over four months. Participants must meet specific health and organ function criteria and will be closely followed up throughout the study period.

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.

Researchers are evaluating whether adding infusions of a special type of immune cells called natural killer NK cells to the chemotherapy regimen gemcitabine and docetaxel GEMDOX can improve outcomes for children and young adults with sarcomas that have come back or did not respond to previous treatments. This study aims to determine the safety and effectiveness of this combined treatment in relapsed or refractory pediatric sarcomas, including osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, and other soft tissue sarcomas. The study is a multi-center, phase 1 and 2 trial with ongoing safety and toxicity analysis conducted by Nationwide Childrens Hospital. Participants receive up to 8 cycles of treatment, each lasting 21 days. Each cycle includes intravenous gemcitabine on days 1 and 8, docetaxel on day 8, oral dexamethasone on days 7 to 9 to prevent side effects, pegfilgrastim on day 9 to help white blood cells recover, and intravenous TGF-beta imprinted TGFb2i, ex vivo expanded universal donor NK cells on day 12. Tumor response is checked after cycles 2, 4, 6, and 8. The study carefully monitors for toxicities related to the combined treatment and tracks how well the NK cells persist in the body and relate to clinical outcomes. During the trial, participants undergo regular assessments including tumor measurements using the RECIST 1.1 criteria every two cycles, evaluation of treatment-related side effects, and laboratory tests to monitor blood counts and organ function. Safety and disease progression are followed for 3 to 5 years. The study also evaluates six-month progression-free survival to understand how well the treatment controls the cancer. Overall, participants will be closely monitored throughout the study and during long-term follow-up to assess the treatments effects and safety.

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 evaluating the safety and anti-tumor activity of OMO-103, a Myc inhibitor, in patients with advanced high-grade osteosarcoma. This phase 2 pilot study aims to provide proof-of-concept data on the drugs effects and tolerability. The study includes patients aged 12 years and older with disease progression after standard chemotherapy. Participants receive OMO-103 intravenously at a dose of 6.5 mgkg once weekly in 28-day cycles. Treatment continues until the cancer progresses or intolerable side effects occur. Additional safety monitoring will be conducted for patients aged 12 to 15 years. The study plans to enroll ten evaluable patients, with at least 30% under 18 years of age. During the study, patients undergo tumor biopsies, imaging scans, and assessments to measure tumor response and drug pharmacokinetics. Quality of life and safety are monitored throughout treatment, with evaluations continuing up to 24 months or until withdrawal. The primary outcome is the anti-tumor activity after 16 weeks of treatment, with ongoing follow-up for safety, tolerability, and treatment effects.