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Sarcoma clinical trials

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NCT ID: NCT06239272 Recruiting - Liposarcoma Clinical Trials

NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

Start date: March 27, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS). Primary Objectives Intermediate-Risk - To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT. - To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics. High-Risk - To estimate the maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants. - To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics. Secondary Objectives - To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol. - To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants. - To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity. - To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib. - To assess the relationship between the pharmacogenetic variation in drug-metabolizing enzymes or drug transporters and the pharmacokinetics of selinexor, pazopanib, and doxorubicin in intermediate- or high-risk patients. Exploratory Objectives - To explore the correlation between radiographic response, pathologic response, survival, and toxicity, and tumor molecular characteristics, as assessed through next-generation sequencing (NGS), including whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing (RNAseq). - To explore the feasibility of determining DNA mutational signatures and homologous repair deficiency status in primary tumor samples and to explore the correlation between these molecular findings and the radiographic response, survival, and toxicity of patients treated on this protocol. - To explore the feasibility of obtaining DNA methylation profiling on pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to assess the correlation with this and pathologic diagnosis, tumor control, and survival outcomes where feasible. - To explore the feasibility of obtaining high resolution single-cell RNA sequencing of pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to characterize the longitudinal changes in tumor heterogeneity and tumor microenvironment. - To explore the feasibility of identifying characteristic alterations in non-rhabdomyosarcoma soft tissue sarcoma in cell-free DNA (cfDNA) in blood as a non-invasive method of detecting and tracking changes during therapy, and to assess the correlation of cfDNA and mutations in tumor samples. - To describe cardiovascular and musculoskeletal health, cardiopulmonary fitness among children and young adults with NRSTS treated on this protocol. - To investigate the potential prognostic value of serum cardiac biomarkers (high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro B-type natriuretic peptide (NT-Pro-BNP), serial electrocardiograms (EKGs), and serial echocardiograms in patients receiving ifosfamide, doxorubicin, and pazopanib, with or without selinexor. - To define the rates of near-complete pathologic response (>90% necrosis) and change in FDG PET maximum standard uptake value (SUVmax) from baseline to week 13 in intermediate risk patients with initially unresectable tumors treated with induction pazopanib, ifosfamide, and doxorubicin, and to correlate this change with tumor control and survival outcomes. - To determine the number of high-risk patients initially judged unresectable at diagnosis that are able to undergo primary tumor resection after treatment with ifosfamide, doxorubicin, selinexor, and pazopanib. - To identify the frequency with which assessment of volumes of interest (VOIs) of target lesions would alter RECIST response assessment compared with standard linear measurements.

NCT ID: NCT06236022 Recruiting - Clinical trials for Dilated Cardiomyopathy

The Effects of Sirolimus in Patients With Dilated Cardiomyopathy Infected With Kaposi Sarcoma-associated Virus

SDCMK
Start date: January 1, 2024
Phase: Phase 4
Study type: Interventional

Evaluating the efficacy of sirolimus (compared to standard therapy alone) in the treatment of dilated cardiomyopathy infected with Kaposi Sarcoma-associated virus -- a multicenter randomized controlled study.

NCT ID: NCT06171282 Recruiting - Sarcoma Clinical Trials

A Clinical Study on Oncolytic Virus Injection (R130) for the Treatment of Advanced Bone and Soft Tissue Tumors

Start date: July 12, 2023
Phase: Early Phase 1
Study type: Interventional

9 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with advanced bone and soft tissue tumors.

NCT ID: NCT06165718 Recruiting - Clinical trials for Pulmonary Artery Sarcoma

Study for the Clinical Roadmap and Prognosis of Pulmonary Artery Sarcoma.

Start date: December 31, 2022
Phase:
Study type: Observational

This is an observational study in which patients with pulmonary artery sarcoma were followed up for at least 36 months and survival was investigated.

NCT ID: NCT06156410 Recruiting - Osteosarcoma Clinical Trials

Cabozantinib With Ifosfamide in Ewing's Sarcoma and Osteosarcoma

Start date: October 24, 2023
Phase: Phase 1
Study type: Interventional

The purpose of this study is to better understand how safe and effective the drug cabozantinib in combination with high-dose ifosfamide is in the treatment of children and adults with relapsed/refractory Ewing sarcoma and osteosarcoma.

NCT ID: NCT06129903 Recruiting - Sarcoma Clinical Trials

Study Assessing the Effects of Early Psychiatric Referral on Mental Health and Quality of Life in People With Sarcoma

Start date: November 7, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the feasibility of early access to mental healthcare during sarcoma treatment as well as to assess the association between early access to psychiatric care and depression, anxiety, postoperative outcomes, and patient satisfaction in patients undergoing surgery for musculoskeletal sarcoma.

NCT ID: NCT06128863 Recruiting - Immunotherapy Clinical Trials

Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial

EFTISARC-NEO
Start date: July 17, 2023
Phase: Phase 2
Study type: Interventional

This is a phase II single-arm single-stage study evaluating efficacy and safety of pembrolizumab in combination with a soluble LAG-3 protein, eftilagimod alpha (Efti) and radiotherapy in neoadjuvant treatment of patients with soft tissue sarcomas. This study will determine the pathologic response rate (defined as percentage of tumor hyalinization/fibrosis) to the combination treatment.

NCT ID: NCT06126510 Recruiting - Sarcoma Clinical Trials

Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma

Start date: July 18, 2023
Phase: Phase 2
Study type: Interventional

This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.

NCT ID: NCT06117878 Recruiting - Soft Tissue Sarcoma Clinical Trials

Safety and Efficacy of NK510 to Treat Osteosarcoma and Soft Tissue Sarcoma

Start date: September 1, 2022
Phase: Early Phase 1
Study type: Interventional

This study will evaluate the safety and efficacy of NK510 in the treatment of Osteosarcoma and Soft Tissue Sarcoma.NK510 will be administered by intravenous injection. The safety and efficacy of this treatment will be evaluated.

NCT ID: NCT06114004 Recruiting - Sarcoma,Soft Tissue Clinical Trials

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

SeliSarc
Start date: September 28, 2023
Phase: Phase 2
Study type: Interventional

Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial. Patients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.