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Osteosarcoma clinical trials

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NCT ID: NCT04644913 Completed - Clinical trials for Osteosarcoma in Children

Long-term Evaluation of the Quality of Life of Former Patients Treated With Orthopedic Surgery, With or Without Radiotherapy

STARTos
Start date: November 18, 2022
Phase:
Study type: Observational

Surgery and radiation therapy play a major role in the treatment of bone and soft tissue tumors. Osteosarcomas, rhabdomyosarcomas, and Ewing tumors are the most common histologic types. Surgery may require multiple techniques and radiation therapy may be conformational, or more recently IMRT (Intensity Modulated Radiation Therapy). If surgery is possible, lower limb surgery is generally the recommended treatment, even if a poor functional result can be expected. The literature is very poor regarding the impact of radiotherapy on quality of life and functional results, mainly with the use of prosthetic materials. Tools such as the Toronto Extremity Salvage Score (TESS) are now available for self-assessment of functional outcomes. The presence of large cohorts such as FCCSS, COHOPER and SALTO facilitates these studies. The SF-36 is a short 36-question health questionnaire that consists of a generic, consistent, and easy-to-administer set of measures. These measures are based on self-report by patients and are now widely used by organizations managing the care of adult patients. The TESS Functional Questionnaire is a patient-completed self-questionnaire widely used for motor stimulation in patients with musculoskeletal tumors. This score is based on the definitions of handicap, impairment and handicap as documented by the World Health Organization (WHO). It includes 30 questions assessing overall function and daily activities. The final score varies from 0% to 100%, 100% being the best possible score. So far, several studies have reported the validation of TESS in Portuguese, Danish, Korean, Japanese and since this year in French. Indeed, the TESS questionnaire was validated in French by the study "Transcultural validation of TESS and MSTS questionnaires" promoted by the Nantes University Hospital.

NCT ID: NCT04634227 Recruiting - Sarcoma Clinical Trials

Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

Start date: November 24, 2020
Phase: Early Phase 1
Study type: Interventional

This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.

NCT ID: NCT04616560 Suspended - Osteosarcoma Clinical Trials

Trastuzumab Deruxtecan for the Treatment of HER2+ Newly Diagnosed or Recurrent Osteosarcoma

Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial studies the effects of trastuzumab deruxtecan in treating patients with HER2 positive osteosarcoma that is newly diagnosed or has come back (recurrent). Trastuzumab deruxtecan is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them.

NCT ID: NCT04616248 Recruiting - Metastatic Melanoma Clinical Trials

In Situ Immunomodulation With CDX-301, Radiation Therapy, CDX-1140 and Poly-ICLC in Patients w/ Unresectable and Metastatic Solid Tumors

Start date: January 9, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial evaluates the side effects of radio-immunotherapy (CDX-301, radiotherapy, CDX-1140 and Poly-ICLC) in treating patients with unresectable and measurable metastatic melanoma, cutaneous squamous cell carcinoma (SCC), Merkel cell carcinoma, high-grade bone and soft tissue sarcoma or HER2/neu(-) breast cancer. CDX-301 may induce cross-presenting dendritic cells, master regulators in the immune system. Radiation therapy uses high energy to kill tumor cells and release antigens that may be picked up, processed and presented by cross-presenting dendritic cells. CDX-1140 and Poly-ICLC may activate tumor antigen-loaded,cross-presenting dendritic cells, and generate tumor-specific T lymphocytes, a type of immune cells, that can search out and attack cancers. Giving immune modulators and radiation therapy may stimulate tumor cell death and activate the immune system.

NCT ID: NCT04595994 Recruiting - Sarcoma,Soft Tissue Clinical Trials

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma

SeliSarc
Start date: September 2, 2020
Phase: Phase 1
Study type: Interventional

Phase I-II, randomized, open-label, multicenter, international clinical trial Patients with advanced soft-tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, alveolar soft-part sarcoma) and osteosarcoma will receive selinexor in combination with gemcitabine.

NCT ID: NCT04571229 Available - Osteosarcoma Clinical Trials

Expanded Access Use of L-MTP-PE for the Treatment of Osteosarcoma

Start date: n/a
Phase:
Study type: Expanded Access

This expanded access protocol will allow access to treatment with L-MTP-PE for people with osteosarcoma. L-MTP-PE is an investigational drug that has not been approved by the FDA to treat any condition, including osteosarcoma. L-MTP-PE works by activating certain types of white blood cells, and these active white blood cells help the immune system kill cancer cells.

NCT ID: NCT04546243 Completed - Pulmonary Disease Clinical Trials

Osteosarcoma With Resectable Pulmonary Metastasis: A Retrospective Study

Start date: January 1, 2020
Phase:
Study type: Observational

According to EURAMOS-1, 17% of osteosarcoma patients were considered to have metastases at diagnosis. In this selected cohort, the reported 5-year EFS from diagnosis of 28% compares well to previous results reported from unselected cohorts of patients with only lung metastases. Resection of pulmonary metastases from osteosarcoma is a treatment option which has been shown to correlate with survival benefit and cure in select individuals. These patients are best addressed in a multidisciplinary fashion, with the involvement of a thoracic surgeon with experience in pulmonary metastasectomy. At the same time, the goal of surgical resection of pulmonary metastases from osteosarcoma is to render the patient completely disease free. "Tumor debulking" or "cytoreductive surgery" with incomplete resection has not demonstrated any survival benefit for patients with pulmonary metastases. Thus open thoracotomy is more preferred than VATS. However over the last decade in China, thoracotomy has not been adopted generally. More patients had chosen VATS or even hypo-fractionation radiotherapy, such as gamma knife, cyber knife and so on as a local treatment method. This study aims to investigate the survival of consecutive patients who had achieved a first complete surgical remission (CR) during combined-modality therapy on neoadjuvant or adjuvant PKUPH-OS protocol so as to discuss reasonable local therapy for resectable pulmonary osteosarcoma metastatic lesions.

NCT ID: NCT04539366 Suspended - Clinical trials for Recurrent Neuroblastoma

Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, The GD2-CAR PERSIST Trial

Start date: January 25, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial investigates the side effects and determines the best dose of an immune cell therapy called GD2CART, as well as how well it works in treating patients with osteosarcoma or neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this trial will come from the patient and will have a new gene put in them that makes them able to recognize GD2, a protein on the surface of tumor cells. These GD2-specific T cells may help the body's immune system identify and kill GD2 positive tumor cells.

NCT ID: NCT04483778 Active, not recruiting - Melanoma Clinical Trials

B7H3 CAR T Cell Immunotherapy for Recurrent/Refractory Solid Tumors in Children and Young Adults

Start date: July 13, 2020
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, non-randomized study that will enroll pediatric and young adult research participants with relapsed or refractory non-CNS solid tumors to evaluate the safety, feasibility, and efficacy of administering T cell products derived from the research participant's blood that have been genetically modified to express a B7H3-specific receptor (chimeric antigen receptor, or CAR) that will target and kill solid tumors that express B7H3. On Arm A of the study, research participants will receive B7H3-specific CAR T cells only. On Arm B of the study, research participants will receive CAR T cells directed at B7H3 and CD19, a marker on the surface of B lymphocytes, following the hypothesis that CD19+ B cells serving in their normal role as antigen presenting cells to T cells will promote the expansion and persistence of the CAR T cells. Arm A CAR T cells include the protein EGFRt and Arm B CAR T cells include the protein HER2tG. These proteins can be used to both track and destroy the CAR T cells in case of undue toxicity. The primary objectives of the study will be to determine the feasibility of manufacturing the cell products, the safety of the T cell product infusion, to determine the maximum tolerated dose of the CAR T cells products, to describe the full toxicity profile of each product, and determine the persistence of the modified cell in the participant's body on each arm. Participants will receive a single dose of T cells comprised of two different subtypes of T cells (CD4 and CD8 T cells) felt to benefit one another once administered to the research participants for improved potential therapeutic effect. The secondary objectives of this protocol are to study the number of modified cells in the patients and the duration they continue to be at detectable levels. The investigators will also quantitate anti-tumor efficacy on each arm. Participants who experience significant and potentially life-threatening toxicities (other than clinically manageable toxicities related to T cells working, called cytokine release syndrome) will receive infusions of cetuximab (an antibody commercially available that targets EGFRt) or trastuzumab (an antibody commercially available that targets HER2tG) to assess the ability of the EGFRt on the T cells to be an effective suicide mechanism for the elimination of the transferred T cell products.

NCT ID: NCT04461223 Recruiting - Osteosarcoma Clinical Trials

Evaluation of Myocardial Injury After Anthracycline Chemotherapy in Osteosarcoma Patients Using CMR

Start date: December 1, 2019
Phase:
Study type: Observational [Patient Registry]

using a contrast-enhanced (CE) cardiac magnetic resonance imaging(CMR) which included the measurement of T1 mapping, T2 mapping, T2* mapping and late gadolinium enhancement(LGE) sequences, as well as LVEF and extracellular volume(ECV) to evaluate the respective changes before and after anthracycline chemotherapy.