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Sarcoma clinical trials

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NCT ID: NCT05646082 Recruiting - Clinical trials for Refractory HIV Associated Kaposi Sarcoma

Preliminary Assessment of Safety and Tolerability of Dostarlimab in Combination Antiretroviral Therapy (cART) Refractory HIV Associated Kaposi Sarcoma

STARKAP
Start date: May 26, 2023
Phase: Phase 1
Study type: Interventional

This is a phase 1b, open label, single arm study evaluating the safety and tolerability of the drug dostarlimab in combination antiretroviral therapy (cART) refractory HIV-associated Kaposi Sarcoma (KS), a rare type of cancer usually seen in people with the HIV infection. Dostarlimab is a type of immunotherapy, and is a monoclonal antibody that has been designed to inhibit the receptor programmed death-1 (PD-1). One of the two ligands for PD-1 has been shown to be upregulated in KS patients, the PDL-1 ligand. By preventing PDL-1 form binding to PD-1, dostarlimab increases the body's immune response to attack more cancer cells. The safety profile of dostarlimab in this specific cancer has not been explored. The primary aim of this study is therefore to provide confirmatory evidence of safety of dostarlimab in KS patients and to preliminary evaluate its effects on HIV reservoirs and assess how it causes its anti-cancer effects through studying tumour tissue before and after treatment. This study will be conducted in two parts and will recruit a total of up to 20 patients. Upon completion of screening investigations inclusive of a fresh tumour biopsy within a 28-days window, patients will receive dostarlimab at the fixed dose of 500 mg dose every 3 weeks for the first 4 doses followed by a fixed 1000 mg dose every 6 weeks. Treatment will be continued until loss of clinical benefit, unacceptable toxicity, patients' withdrawal or completion of a total of 48 weeks of treatment. Part 1 will consist of 6 patients being dosed and observed for toxicity for 21 days following first dose. A trial steering committee will evaluate any treatment related adverse events (AEs) and dose-limiting toxicities (DLTs) reported before deciding on whether to continue onto part 2, where a further 14 patients may be enrolled.

NCT ID: NCT05634369 Recruiting - Clinical trials for Pediatric Sarcoma, Relapsed

A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue

TINKS
Start date: November 14, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies. The goals of this study are: - To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGFβ imprinted (TGFβi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma. - To identify toxicities related to treatment with GEM/DOX + TGFβi expanded NK cells Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles. - Gemcitabine (GEM): via IV on Days 1 and 8 - Docetaxel (DOX): via IV on Day 8 - Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction - Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given - TGFβi NK cells: via IV on Day 12

NCT ID: NCT05631379 Recruiting - Sarcopenia Clinical Trials

Influence of Nutritional Status on Oncologic and Operative Outcome in Patients Operated for Retroperitoneal Sarcoma

Start date: December 2, 2022
Phase:
Study type: Observational

This is a retrospective, observational study in consecutive patients operated on for primary RPS in the Institute of Oncology Ljubljana (Slovenia) between September 1999 and June 2020. This study aims to investigate the impact of preoperatively assessed body composition parameters on the perioperative outcomes of patients operated on for primary RPS. The impact of preoperative malnutrition, sarcopenia, sarcopenic obesity and myosteatosis to the oncologic and postoperative outcome in patients operated on for primary RPS will be examined. Additionally, the aim is to evaluate the prognostic role of preoperative immune and inflammatory markers (serum albumin level, C-reactive protein, neutrophil to lymphocyte ratio, platelet to lymphocyte ratio, high-sensitivity modified Glasgow prognostic score) and prognostic nutritional index in primary RPS patients undergoing surgery. Patient outcome will be evaluated in terms of overall survival (OS), local-recurrence free survival (LRFS), postoperative intrahospital length of stay, overall and major postoperative morbidity.

NCT ID: NCT05621668 Recruiting - Soft Tissue Sarcoma Clinical Trials

A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell Therapy in Subjects With Advanced/Metastatic Soft Tissue and Bone Sarcoma

Start date: September 8, 2023
Phase: Phase 1
Study type: Interventional

To find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.

NCT ID: NCT05620693 Recruiting - Clinical trials for Advanced Soft-tissue Sarcoma

Study of NY-ESO-1 TCR-T in Advanced Soft Tissue Sarcoma

Start date: November 11, 2022
Phase: N/A
Study type: Interventional

Soft tissue sarcoma (STS) is a kind of solid tumor with high heterogeneity. There is no standard second-line treatment plan for patients who have failed first-line treatment. NY-ESO-1, a cancer testis antigen, is highly expressed in soft tissue tumors and is an ideal therapeutic target. Investigators aim to testify the safety and efficacy of NY-ESO-1 TCR-T cell in advanced soft tissue sarcoma.

NCT ID: NCT05617859 Recruiting - Sexuality Clinical Trials

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

Start date: April 30, 2023
Phase: Phase 2
Study type: Interventional

A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety.

NCT ID: NCT05615545 Recruiting - Sarcoma Clinical Trials

Cryoablation for Advanced Bone and Soft Tissue Tumors

Start date: March 10, 2022
Phase:
Study type: Observational

This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

NCT ID: NCT05614375 Recruiting - Surgery Clinical Trials

Endoscopic Surgery in the Treatment of Soft Tissue Sarcoma in Nasal and Paranasal Sinus

Start date: June 12, 2021
Phase:
Study type: Observational [Patient Registry]

Soft tissue sarcoma (STS) refers to a group of malignant tumors derived from non-epithelial extraosseous tissues, mainly from the mesoderm, partly from the neuroectoderm, including muscle, fat, fibrous tissue, blood vessels and peripheral nerves . STS is divided into 12 major categories based on tissue origin. According to different morphologies and biological behaviors, there are more than 50 subtypes. The most common subtypes include: undifferentiated pleomorphic sarcoma (UPS), liposarcoma (LPS), leiomyosarcoma (LMS), synovial sarcoma ( SS). The most common soft tissue sarcoma in children and adolescents is rhabdomyosarcoma (RMS). Soft tissue sarcoma is a group of highly heterogeneous tumors, which are characterized by local invasiveness, invasive or destructive growth, local recurrence and distant metastasis. The pathological features of STS that occur in the nasal cavity and sinuses are similar to other parts of the body. However, because it can affect important structures such as the orbit, optic nerve, skull base bone, dura mater, cranial nerve and even brain tissue, the diseased site is deep, the anatomical structure is complex, the treatment is difficult, the range of surgical resection is limited, and the surgical margin Negative is difficult to guarantee, and related treatments may have obvious complications, which affect the survival and prognosis of patients. Surgical treatment is the most important and most likely effective treatment for STS. With the development of endoscopic skull base anatomy and surgical techniques, the safety and effectiveness of endoscopic sinus surgery for the treatment of nasal cavity and sinus tumors have been fully confirmed, and it has become the main surgical method for nasal cavity and sinus STS. This is also the theoretical and practical basis for the feasibility of this research. The study intends to conduct a single-arm, prospective, observational study of endoscopic sinus surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses to explore the therapeutic effect and complications of endoscopic surgery for the treatment of soft tissue sarcoma of the nasal cavity and paranasal sinuses, and explore its relationship with chemotherapy and radiotherapy. The model of comprehensive treatment between.

NCT ID: NCT05605522 Recruiting - Colorectal Cancer Clinical Trials

A Study of [225Ac]-FPI-2059 in Adult Participants With Solid Tumours

Start date: February 7, 2023
Phase: Phase 1
Study type: Interventional

This is a first-in-human Phase 1 clinical trial designed to investigate the safety, tolerability, pharmacokinetics, and biodistribution of [225Ac]-FPI-2059 and [111In]-FPI-2058 in participants with neurotensin receptor 1 (NTSR1)-expressing solid tumours.

NCT ID: NCT05602792 Recruiting - Breast Cancer Clinical Trials

A Study of T3011 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors

Start date: April 21, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Phase I/IIa Study of the Safety and Tolerability of T3011 Administered via Intratumoral Injection in Patients with Advanced Solid Tumors