Soft Tissue Sarcoma Clinical Trials

Checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance, and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not currently thought to be an effective intervention in the treatment of several immunologically "cold" tumors such as prostate cancer, biliary tract cancers, soft tissue sarcomas, well-differentiated neuroendocrine tumors, microsatellite stable colorectal cancer, pancreatic cancer, and non-triple negative breast cancer. Vascular endothelial growth factor (VEGF) is thought to play a key role in modulating the anti-tumor immune response. Vascular endothelial growth factor (VEGF) is secreted by tumors and leads to endothelial cell proliferation, vascular permeability, and vasodilation. This in turn leads to the development of an abnormal vasculature with excessive permeability and poor blood flow, limiting immune surveillance. In addition, VEGF inhibits dendritic cell differentiation, limiting the presentation of tumor antigens to CD4 and CD8 T cells. Vascular endothelial growth factor (VEGF). VEGF tyrosine kinase inhibitors (TKIs) VEGF-TKIs are currently utilized in the treatment of a variety of malignancies and are widely utilized in combination with checkpoint blockade in the treatment of clear cell kidney cancer. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade even in tumors which have traditionally been thought to be unresponsive to immunotherapy. This study aims to evaluate the combination of the immune checkpoint inhibitor atezolizumab and the VEGF-TKI tivozanib in a variety of tumors which have a low response rate to checkpoint inhibitor therapy alone. Read Less

This study is planned to test the safety and tolerability of the TIL regimen. The study will also test how well TIL fights cancer. The study will enroll children, teenagers, and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist. Study details include: * The study will last up to 2 years after the TIL infusion (Day 0) for each person. * The treatment will last up to 10 days for each person. * Study visits will be every 2 weeks until Day 42, every 6 weeks until Month 6, and every 3 months until Year 2. Read Less

3CAR is being done to investigate an immunotherapy for patients with solid tumors. It is a Phase I clinical trial evaluating the use of autologous T cells genetically engineered to express B7-H3-CARs for patients ≤ 21 years old, with relapsed/refractory B7-H3+ solid tumors. This study will evaluate the safety and maximum tolerated dose of B7-H3-CAR T cells.The purpose of this study is to find the maximum (highest) dose of B7-H3-CAR T cells that are safe to give to patients with B7-H3-positive solid tumors. Primary objective To determine the safety of one intravenous infusion of autologous, B7-H3-CAR T cells in patients (≤ 21 years) with recurrent/refractory B7-H3+ solid tumors after lymphodepleting chemotherapy Secondary objective To evaluate the antitumor activity of B7-H3-CAR T cells Exploratory objectives * To evaluate the tumor environment after treatment with B7-H3-CAR T cells * To assess the immunophenotype, clonal structure and endogenous repertoire of B7-H3-CAR T cells and unmodified T cells * To characterize the cytokine profile in the peripheral blood after treatment with B7-H3-CAR T cells Read Less

The purpose of this research study is to preserve healthy tissue around the cancer on the arm(s) and/or leg(s) using Hypofractionated radiotherapy, while treating the cancer and preventing it from spreading to other areas of the body. Read Less

This study is being done to find out whether the study drug Retifanlimab, a monoclonal antibody against the PD-1 protein, combined with gemcitabine and docetaxel, is a safe and effective treatment for your disease. Gemcitabine and docetaxel are chemotherapy drugs that are commonly used to treat soft tissue sarcoma. Retifanlimab is an experimental drug that boosts the immune system's ability to fight cancer cells. The study researchers think that Retifanlimab may help gemcitabine and docetaxel work better against soft tissue sarcoma that is either locally advanced or has spread beyond its original location (metastasized), and it cannot be removed with surgery (unresectable). Read Less

The purpose of this study is to evaluate the effect of a neoadjuvant (i.e. pre-treatment) exercise regimen on extremity function and postoperative wound healing. The study group will include patients with a primary diagnosis of soft tissue sarcoma undergoing treatment with neoadjuvant radiation therapy and surgical resection. Patients with upper or lower extremity sarcomas will be considered for enrollment. Read Less

This is a first-in-human (FIH), Phase 1 open-label, multicentre dose escalation study investigating AVA6000 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumours that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion. Read Less

This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures. Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team. Read Less

This study is investigating the feasibility of preoperative 5-day hypofractionated radiotherapy (HFRT) for extremity soft tissue sarcoma (STS). The primary objective is to assess the uptake of 5-day HFRT in patients with STS who are candidates for preoperative radiotherapy and limb preserving surgery. Secondary objectives include evaluation of the rates of favorable pathologic response, major wound complications, local control, acute toxicity, and 1-year late toxicity will be assessed. Exploratory objectives include evaluation of the impact of preoperative 5-day HFRT on access to care, the socio-demographic profile of the trial participants will be compared to that of extremity STS patients seen within Hollings Cancer Center (HCC) and recommended preoperative conventional fractionation radiotherapy (CFRT) in the 3 years prior to the study opening. The retention rate for radiotherapy at HCC in patients meeting trial criteria during the prior 3 years will be compared with the retention rate for radiotherapy during the study period. An exploratory analysis will measure serum SFRP2 pre- and post- radiotherapy to assess changes in response to preoperative 5-day HFRT. Changes in serum SFRP2 will be evaluated for association with a favorable pathologic response to determine the potential of serum SFRP2 as a predictive biomarker. Patient satisfaction with the decision to participate in a trial of preoperative 5-day HFRT will be assessed. Read Less

The purpose of this Phase 1 research study is to obtain data or information on the safety and effectiveness of the combination of gemcitabine, docetaxel with radiation. Read Less

In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy. Read Less

The purpose of this study is to examine the safety and efficacy of an abbreviated course of preoperative radiation, given over five days, for patients with soft tissue sarcoma of the extremity, trunk or retroperitoneum. This is in contrast to standard preoperative radiation, which is given over 25 days. Read Less