Bone Tumor

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.

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.

This research aims to study and treat individuals with various bone and mineral disorders at the NIH Clinical Center. It provides an opportunity to collect bone specimens for research and to increase knowledge of skeletal diseases, supporting further studies in bone biology. Participants include those with both common and rare bone and mineral metabolism disorders, with evaluations tailored to each diagnosis. Participants receive standard care evaluations and treatments for their bone conditions, without experimental procedures. Assessments include medical history, physical exams, blood and urine tests, and imaging such as X-rays, CT scans, MRIs, bone densitometry, and bone scans. Bone samples may be collected during planned surgeries or through bone biopsies as part of participant evaluation. Throughout the study, participants undergo medical assessments and specimen collection at times specific to their diagnosis. Researchers analyze clinical and research specimens, including genetic and biochemical evaluations of surgical waste materials. The study also aims to create a database of participant information and biological samples to support future research. Participation duration and specific procedures vary by individual 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 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.

Researchers are evaluating the effectiveness and safety of using Trilaciclib to prevent chemotherapy-related myelosuppression in patients with Ewings 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 Ewings sarcoma. The study compares the use of Trilaciclib combined with standard VDCIE chemotherapy versus chemotherapy alone. Participants will be randomly assigned to one of two groups the experimental group receiving Trilaciclib along with alternating VDCIE chemotherapy every 3 weeks for up to 17 cycles, or the control group receiving only the alternating VDCIE 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.

Researchers are evaluating DXC008 in a phase I, open-label, first-in-human clinical trial to study its safety, tolerability, maximum tolerated dose, dose-limiting toxicities, recommended dose for further studies, pharmacokinetics, preliminary anti-tumor activity, and immune response in patients with prostate cancer and other solid tumors like Ewing sarcoma. The study aims to understand how DXC008 behaves in the body and its initial effects on tumors. Participants receive DXC008 in two dosing schedules one group receives the drug once every two weeks in 14-day cycles, and another group receives it once every three weeks in 21-day cycles. This dose escalation and expansion study is designed to carefully monitor patients as the dose is increased to find appropriate levels for safety and effectiveness. The study is open-label, meaning participants and researchers know the treatment being given. Throughout the trial, participants undergo regular assessments including monitoring for dose-limiting toxicities and adverse events over an average of one year following the first infusion. Researchers also measure drug levels in the blood, tumor response using recognized criteria, and immune reactions. Safety and clinical responses are tracked closely with imaging and laboratory tests. The total participation duration can extend up to about one year after enrollment depending on individual responses and study procedures.

Researchers are evaluating whether adding the drugs gefitinib, trametinib, disulfiram, and sunitinib to standard chemotherapy improves treatment outcomes for people with osteosarcoma, a type of bone cancer. This Phase 2 study also aims to assess the safety of combining these drugs with chemotherapy and to better understand how osteosarcoma resists treatment by analyzing additional tumor biopsies from participants in one group. The study focuses on patients with high-risk metastatic osteosarcoma, including newly diagnosed and relapsed cases. Participants will receive standard chemotherapy, either MAP chemotherapy or ifosfamide chemotherapy, alongside one or a combination of the study drugs gefitinib, trametinib, disulfiram, or sunitinib. Treatment is given in 6 cycles, each lasting 21 or 28 days depending on the chemotherapy type. A separate group will undergo research biopsies without receiving study drugs. The study includes three cohorts based on diagnosis and disease status, with specific criteria for enrollment. During the study, participants will be monitored for progression-free survival over 12 months or overall survival over 24 months, depending on their cohort. They will undergo research biopsies before and during treatment to study tumor response and resistance. Researchers will assess organ function, performance status, and ability to take oral medications. Participants will be followed closely throughout the treatment cycles with scheduled visits and evaluations, and their safety will be monitored carefully throughout the study period.

Researchers are evaluating the safety and effectiveness of KC1036 in adolescents aged 12 to under 18 years with advanced Ewing sarcoma, a type of cancer that is locally advanced or metastatic and has not responded to standard treatments. This open-label, single-arm Phase II clinical trial focuses on patients with no other treatment options, aiming to assess how well KC1036 works and its safety profile over approximately three years. Participants will take KC1036 orally once daily in 4-week treatment cycles. Dosage depends on body weight 40 mg daily for those weighing 30 to less than 50 kg, 50 mg daily for 50 to less than 70 kg, and 60 mg daily for 70 kg or more. The study does not involve a comparison group and continues treatment cycles as long as participants meet criteria. During the trial, participants will be monitored for adverse events and various measures of cancer response, including objective response rate, disease control rate, progression-free survival, and duration of response, over about three years. Participants will undergo regular assessments such as imaging to evaluate measurable lesions, organ function tests, and pregnancy tests when applicable. The study includes safety monitoring and requires informed consent from both patients and their legal guardians.