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Soft Tissue Sarcoma clinical trials

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NCT ID: NCT02910895 Recruiting - Soft Tissue Sarcoma Clinical Trials

A Platform of Patient Derived Xenografts (PDX) and 2D/3D Cell Cultures of Soft Tissue Sarcomas (STS)

SarcomaPDX
Start date: September 9, 2017
Phase: N/A
Study type: Interventional

Outside the setting of well-designed prospective clinical studies, the current standard preoperative RT should be a conventionally 1.8-2 Gy fractionated regimen to a total dose of 50 Gy in 5-6 weeks. However, given the vast diversity of sarcoma subtypes, it is also unlikely to assume a uniform therapeutic management to be optimal for all sarcomas alike. Other than 2 Gy fraction sizes and/or 50 Gy total dose series have been investigated in the past and should be further exploited in the future, but the practical implementation in humans is hampered by the rarity of the disease. The current systemic treatment of sarcomas consists of both the older cytotoxic chemotherapies and the newer targeted therapies like tyrosine kinase inhibitors. But it is hard to predict which patients will respond to which specific systemic treatment. This leads to worse prognoses and unnecessary toxicity for sarcoma patients. Despite the fact that the number of sarcoma patients in current studies is too small with a mix of different subtypes, some subtypes show a better response than other subtypes. This platform may form the basis for preclinical translational investigations with radiotherapy and various systemic treatments.

NCT ID: NCT02811523 Recruiting - Soft Tissue Sarcoma Clinical Trials

In Vivo Lung Perfusion for Pulmonary Metastases of Sarcoma

Start date: February 2016
Phase: Phase 1
Study type: Interventional

Sarcoma which has spread to the lungs is most often treated with surgery. Even with surgery, most patients will not be cured and will die from their disease, probably because of small cancer cells that are present in the lungs at the time of surgery, but cannot be seen or detected. It is for this reason that we are looking for a better treatment. Giving chemotherapy after surgery is generally not recommended because it has significant side effects and no benefit has been proven. This study is investigating a new technique for delivering chemotherapy directly into the lungs at the time of surgery. Delivering chemotherapy directly to the lungs could potentially kill any microscopic cancer cells that are present in the lungs at the time of surgery, while sparing other major organs in the body from the side effects of chemotherapy. This technique is called In Vivo Lung Perfusion (IVLP). This is a Phase I, non-randomized, dose escalation study that will act as a pilot study for a larger prospective, multicenter, controlled clinical trial. Patients who have bilateral disease will have one lung undergo IVLP and the other lung will remain untreated with the IVLP (the other lung will be treated as current standard of care - either surgery or radiation) as a control lung. The patients will undergo a posterolateral thoracotomy. Lung metastases will be identified by visualization or palpation. After surgical isolation of the lung by proximal control of pulmonary artery and veins, IVLP will be initiated. After 3 hours of IVLP, the lung metastases will be removed in the usual fashion. Patients will be cared for post-surgery according to institutional standards. The patients will be followed for up to 2 years. The primary endpoint is safety. Secondary endpoints include additional safety endpoints and efficacy.

NCT ID: NCT02632448 Recruiting - Breast Cancer Clinical Trials

A Study of LY2880070 in Participants With Advanced or Metastatic Cancer

Start date: May 16, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The main purpose of this 3-part study is to evaluate the safety and efficacy of the study drug known as LY2880070 in participants with advanced or metastatic solid tumors.

NCT ID: NCT02630368 Recruiting - Breast Cancer Clinical Trials

A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX)

METROmaJX
Start date: September 18, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Assessment of the efficacy and safety of JX-594 and metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma and advanced breast cancer, once the Maximum Tolerated Dose have been determined (phase I trial). Phase I study: this is a prospective open-labeled phase I trial based on a dose escalating study design assessing two dose levels of JX594 when prescribed in combination with metronomic cyclophosphamide. Phase II trials with two treatments strategies: Metronomic CP + JX-594: phase II study sarcoma: this is a monocentric, randomized two-arm non comparative phase 2 study assessing efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma. Metronomic CP + JX-594: phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing efficacy and safety of JX-594 in association with metronomic cyclophosphamide in patients with advanced breast cancer. Metronomic CP + JX-594 + Avelumab: phase II study sarcoma: this is a monocentric, single arm phase II study assessing efficacy and safety of avelumab in combination with IT JX-594 and metronomic cyclophosphamide in patients with advanced soft-tissue sarcoma. Metronomic CP + JX-594 + Avelumab:: phase II study breast cancer: this is a monocentric, single-arm phase II study, assessing efficacy and safety of avelumab in combination with IT JX-594 and metronomic cyclophosphamide in patients with advanced breast cancer.

NCT ID: NCT01904565 Recruiting - Soft Tissue Sarcoma Clinical Trials

Hyperthermia and Proton Therapy in Unresectable Soft Tissue Sarcoma

HYPROSAR
Start date: February 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-institutional phase I/II clinical trial with concomitant local hyperthermia and proton beam radiotherapy in patients with primary or recurrent unresectable soft tissue sarcomas of the extremities, trunk, retroperitoneum (except intrabdominal). The primary purpose would be to assess the safety and efficacy of this approach along with local tumour regressions and subsequent tumour downstaging, thereby enabling a near total removal of these tumours following the hyperthermia and proton beam therapy.

NCT ID: NCT01812018 Recruiting - Soft Tissue Sarcoma Clinical Trials

Endostar + GT in Pulmonary Metastases of Soft Tissue Sarcoma

Start date: November 2012
Phase: Phase 2
Study type: Interventional

The purpose of this exploratory phase II study is to assess the effectiveness and safety profile of Endostar®(Recombinant Human Endostatin Injection) plus Gemcitabine and Docetaxel in treatment of soft tissue sarcoma patients with pulmonary metastases.

NCT ID: NCT00898755 Recruiting - Lymphoma Clinical Trials

Collecting and Storing Tissue From Young Patients With Cancer

Start date: March 5, 2007
Phase:
Study type: Observational

This laboratory study is collecting and storing tissue, blood, and bone marrow samples from young patients with cancer. Collecting and storing samples of tissue, blood, and bone marrow from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

NCT ID: NCT00790244 Recruiting - Soft Tissue Sarcoma Clinical Trials

A Scandinavian Sarcoma Group Protocol for Patients With High-risk Soft Tissue Sarcoma of the Extremities and Trunk Wall

SSGXX
Start date: October 2007
Phase: Phase 2
Study type: Interventional

SSG XX is a phase II trial for high-risk soft tissue sarcomas (STS) of the extremities and trunk wall. Prognostic factors (histopathological markers) are used to identify high-risk tumors. SSG XX will evaluate chemo- and radiotherapy given adjuvantly to these patients. In a specified group of patients also preoperatively given therapy will be studied.

NCT ID: NCT00753727 Recruiting - Soft Tissue Sarcoma Clinical Trials

Sunitinib and Radiation in Patients With Resectable Soft-tissue Sarcoma

SUNXRT
Start date: September 2008
Phase: Phase 1/Phase 2
Study type: Interventional

This research is being done with the aim of developing a more effective treatment than standard radiotherapy and surgery alone. Although standard treatment is frequently successful, some patients do not respond well to this treatment. Low oxygen levels in tumours, which may be a particular problem with sarcomas, are thought to be one factor that contributes to failure of radiotherapy. Sunitinib is a new drug that is active against cells with low oxygen levels. The combination of sunitinib and radiotherapy has shown promising results in other cancers. The purpose of this study is to find out whether treatment with a new drug, sunitinib, can increase the effectiveness of radiotherapy at killing cancer cells; to test the safety of the combination of sunitinib and radiotherapy.

NCT ID: NCT00541840 Recruiting - Soft Tissue Sarcoma Clinical Trials

Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma

Start date: October 2007
Phase: Phase 1/Phase 2
Study type: Interventional

Soft tissue sarcomas (STS) are an uncommon group of malignant tumors of mesenchymal origin. For most advanced STS types, chemotherapy is currently the only available treatment. Unfortunately, a very limited number of useful drugs are active against this disease. Doxorubicin is widely considered the standard first-line treatment. Ifosfamide has also a well-established activity (1,2) and is often administered either associated with Doxorubicin or alone as a second-line chemotherapy treatment. Other drugs such as DTIC, Gemcitabine and Temozolomide showed modest activity as a second-line agents (3,4). Thus, there is a necessity to identify new agents with activity to improve therapy for patients with advanced STS. In some studies, most STS showed VEGF expression, and elevated serum VEGF levels were found to correlate with higher histologic tumor grade (5,6). Additionally, inhibition of VEGFR was associated with tumor activity in preclinical models of sarcoma (7,8). For these reasons, inhibition of VEGFR seems to be a reasonable approach to explore in the treatment of STS. Sorafenib (BAY 43-9006) is an orally available, small molecule multi-kinase inhibitor of VEGFR, PDGFR and RAF with demonstrated activity in the treatment of renal cell cancer (9). Preclinical studies suggest that the combination of Sorafenib with cytotoxic agents results in additive anti-tumor activity (10), initiating justification for combination studies. A recent trial, however, reported an unexpected incidence of cardiac toxicity in patients with STS treated with Bevacizumab, a monoclonal antibody that binds VEGF, in combination with Doxorubicin (11). This finding suggest that the possibility of potentiation of the cardiotoxicity of Doxorubicin when inhibiting the VEGF pathway cannot be ruled out. The association of Sorafenib with Ifosfamide, the other established active agent against STS, could improve the efficacy of single-agent Ifosfamide minimizing the risk of cardiac toxicity .