Bone Neoplasm

Researchers are investigating the tumor necrosis rate in patients with osteosarcoma treated with a neoadjuvant regimen combining surufatinib and chemotherapy. This phase II, prospective, multicenter, controlled study aims to assess the efficacy and safety of surufatinib, a drug that inhibits colony-stimulating factor 1 receptor, which may have tumor-inhibiting effects on sarcoma. The study includes 160 participants divided into two groups to compare surufatinib plus chemotherapy versus chemotherapy alone. Participants in the study receive treatment cycles lasting 30 days. One group receives surufatinib combined with chemotherapy, while the other receives chemotherapy only. The surufatinib dose varies by age and body surface area, with specific chemotherapy drugs administered in a set schedule over the cycle. After two cycles of neoadjuvant therapy, the tumor necrosis rate is evaluated to measure treatment impact. During the study, participants undergo evaluations including tumor assessments, blood tests, and monitoring for adverse events. The primary outcome is the tumor cell necrosis rate after 12 months. Secondary outcomes include progression-free survival at one year and safety assessments over 24 months according to standard criteria. Participants are monitored for organ function, tumor response, and treatment side effects throughout the treatment and follow-up periods.

Researchers are studying the safety and effectiveness of a modified herpes simplex virus called R130 for treating advanced bone and soft tissue tumors, including osteosarcoma and sarcoma. This early-phase, open-label clinical trial aims to learn how this oncolytic virus works in patients who have relapsed or refractory tumors and have not responded to standard treatments or choose not to receive other therapies. Participants will receive injections of 1 to 2 ml of R130, containing 1x10^8 plaque-forming units per milliliter, directly into their tumors every 7 to 14 days. The treatment focuses on patients with measurable lesions suitable for direct injection. This single-arm study does not include a comparison group and is sponsored by Shanghai Yunying Medical Technology. During the study, patients will be closely monitored for adverse events and laboratory changes up to 6 months after treatment. Researchers will assess immune responses, disease control, duration of response, and quality of life over a 12-month period with scheduled evaluations every 6 to 10 weeks. Participants must meet certain health and organ function requirements and will be followed for safety and outcomes throughout the trial.

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 participant's 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.

Researchers are investigating real-world outcomes for patients with symptomatic, high-risk bone metastases who receive both percutaneous ablation and palliative radiation therapy. The study aims to understand effects on pain, patient-reported outcomes, skeletal events, and healthcare use in this population. This observational trial is sponsored by the Society of Interventional Oncology and focuses on adults aged 21 and older with bone metastatic cancer. The study observes patients treated with percutaneous ablation, a minimally invasive method targeting pain-causing nerves and tumor tissues, alongside radiation therapy, which is commonly used to relieve pain from bone metastases. Treatments are given under specialists' review, ensuring lesions are suitable for both procedures. No prior targeted radiation or ablation should have been performed on the lesion to be studied. Participants will be monitored over time through patient-reported outcome surveys like PROMIS®, BPI, COST-FACIT, and OMED for up to 12 months. The primary measure is pain response assessed at three months following treatment. The study also tracks safety, skeletal related events, and healthcare usage, with follow-up focused on those with a life expectancy greater than three months and an ECOG performance status of 0-2.

Researchers are studying individuals with bone and mineral disorders to better understand these conditions and improve knowledge about bone biology. The study allows patients with various skeletal diseases to be evaluated and treated at the NIH Clinical Center, while also offering training opportunities for NIH trainees. The research includes collecting bone specimens from patients to support further study of bone diseases. Participants receive evaluations that include medical history reviews, physical exams, and standard tests such as blood and urine analysis, X-rays, bone densitometry, bone scans, CT scans, and MRI. Bone samples may be collected either from tissue removed during planned surgical procedures or via bone biopsy as part of the evaluation. No experimental treatments or tests are involved; all procedures are part of routine care for skeletal diseases. Throughout the study, patients undergo clinical assessments tailored to their diagnosis at specific times. Researchers collect and analyze clinical data and biological specimens, including genetic and biochemical tests on surgical waste material. The study aims to build a database containing detailed information and specimens from participants to support future research. Participation duration and specific assessments vary depending on each participant's condition and needs.

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 1/1b 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 drug's 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 mg/kg 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.

This trial investigates the use of stereotactic body radiation therapy (SBRT) compared to conventional palliative radiation therapy for people with painful bone metastases caused by solid tumors. The study aims to find out which radiation schedule and dose better relieve pain, with pain response measured at multiple time points up to several months after treatment. The research also evaluates treatment safety, survival, and quality of life outcomes. Participants receive radiation therapy in one of two groups: standard dose or high dose. The standard dose group may get 8 Gy in one session or 20 Gy over five sessions, while the high dose group may receive 16 Gy in one session or 27 Gy over three sessions. Radiation treatments are given daily over consecutive days, not counting weekends or holidays, depending on the assigned schedule. During the study, participants will have their pain assessed at 2 weeks, 1 month, 3 months, and then every 3 months after treatment. Researchers will also review imaging to check for cancer progression, monitor pain medication use, record any additional treatments or surgeries, and track side effects. Quality of life surveys will be completed, and adverse events will be followed for about one year. The total time participants are involved depends on follow-up schedules and treatment response.

Researchers are evaluating the effectiveness and safety of using Trilaciclib to prevent chemotherapy-related myelosuppression in patients with Ewing's sarcoma who have not previously received systemic anti-tumor treatment. This is a phase 2, prospective, randomized, controlled clinical trial focusing on patients aged 14 to 40 years with confirmed Ewing's sarcoma. The study compares the use of Trilaciclib combined with standard VDC+IE chemotherapy versus chemotherapy alone. Participants will be randomly assigned to one of two groups: the experimental group receiving Trilaciclib along with alternating VDC+IE chemotherapy every 3 weeks for up to 17 cycles, or the control group receiving only the alternating VDC+IE chemotherapy on the same schedule. The chemotherapy regimen includes vincristine, doxorubicin (or actinomycin D after a certain cumulative dose), cyclophosphamide, ifosfamide, and etoposide. Trilaciclib is given as an intravenous infusion following chemotherapy administration in the experimental group. Supportive care is allowed in both groups as needed. During the treatment, participants will be monitored for myelosuppression effects such as neutropenia and thrombocytopenia through laboratory tests. The primary outcome measures how long severe neutropenia lasts in the first treatment cycle, with additional outcomes tracking recovery times, incidence of febrile neutropenia, anemia, and serious infections across multiple cycles. The study will also assess event-free survival up to 24 months. Treatment continues until disease progression, unacceptable side effects, or withdrawal. The total study duration includes up to 17 cycles of treatment and follow-up assessments.

Researchers are studying patients with periacetabular tumors who undergo reconstruction surgery after tumor removal. The study aims to find out if using a modified angle for placing the acetabular cup during surgery reduces the risk of hip dislocation within one year compared to the conventional angle. This research is a multi-center, double-blinded, randomized controlled trial led by the Second Affiliated Hospital, School of Medicine, Zhejiang University. Participants are randomly assigned to receive either the modified anteversion angle placement or the conventional anteversion angle placement of the acetabular component during surgery. Both approaches use a 3D-printed osteotomy guide and prosthesis with pre-designed angles. Intraoperative X-ray fluoroscopy checks the cup angle to ensure it matches the predetermined criteria, adjusting it if necessary. During the one-year follow-up after surgery, researchers will monitor hip dislocation occurrences as the primary outcome. They will also assess function and recovery using MSTS and TESS scores and evaluate failure modes at 1 month, 3 months, 6 months, 9 months, and 1 year. The study includes detailed surgical evaluation and postoperative follow-up to measure safety and outcomes over this period.