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Sarcoma clinical trials

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NCT ID: NCT02275286 Recruiting - Leiomyosarcoma Clinical Trials

Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients

TRASTS
Start date: November 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Phase I-II trial that combines trabectedin plus radiotherapy for tumor reduction response measure in four cohorts of patients: Cohort A: Patients with diagnosis of non-operable or unresectable or not oncologically recommended metastasectomy of limited to lung metastases soft tissue sarcoma. Cohort B: Patients with locally advanced resectable Myxoid Liposarcoma. Cohort C: Patients with retroperitoneal and resectable soft tissue sarcoma (liposarcoma and leiomyosarcoma). Cohort D (Phase II only): Patients with well differentiated liposarcoma and G2 dedifferentiated liposarcoma (with less than 30% dedifferentiated component). Phase I: escalating dose of 1.3 or 1.5 mg/m2. Phase I for cohort C: de-escalating dose of 1.5 or 1.3mg/m2 Radiotherapy for cohort A: 30Gy in 10 fractions (3Gy/fraction). Radiotherapy for cohort B: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort C: 45Gy in 25 fractions (1.8Gy/fraction). Radiotherapy for cohort D: 45Gy in 25 fractions (1.8Gy/fraction). A translational substudy is developed to analyse different biomarkers predictive value. Cohorts A and B are closed to recruitment in 2023.

NCT ID: NCT02212639 Recruiting - Clinical trials for Endemic Kaposi' s Sarcoma

Phase II Multicentric Study of Digoxin Per os in Classic or Endemic Kaposi' s Sarcoma

KADIG 01
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Classic and endemic Kaposi's sarcoma (KS) are lymph angio proliferations associated with human herpes virus 8 (HHV8) which treatment is poorly codified. Chemotherapies give at best 30-60% of transient responses. While interferon responses are frequent, this drug is often poorly tolerated in elderly patients. Therefore new therapies are needed. Classic KS represents an ideal model for evaluating new drugs since patients do not receive concomitant immunosuppressive regimens nor antiviral therapies. Hypoxia-inducible factor 1(HIF-1 alpha) is a major regulator of solid tumor growth and therefore a suitable target currently explored in many cancers. Moreover HIF-1 alpha enhances HHV-8 gene expression in KS and induces lytic replication cycle. Digoxin has anti cancer effect in vivo through HIF-alpha down regulation in several preclinical tumor models including KS. The identification of HIF-1 alpha as a key factor in HHV8 replication prompt us to explore inhibition of HIF-1 alpha by digoxin as a potential therapeutic approach for KS treatment it has and consequently may down regulate HHV-8 replication in KS. This latter approach is heightened by recent data suggesting that Digoxin has some efficacy in vitro against others human herpes virus i.e. Herpes simplex and Cytomegalovirus (8) (9) In this study the investigators shall evaluate the benefit and safety profile of digoxin in classic and endemic KS (serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years and between 0.5-0.8 ng/ml in patients older than 75 years The participants will take study drug digoxin, for a total of 6 cycles (4 weeks/cycle).

NCT ID: NCT02120768 Recruiting - Clinical trials for Local Recurrence of Malignant Tumor of Soft Tissue

Role of Barrier Resection in Local Control for Extremity Recurrent Soft Tissue Sarcomas

Start date: March 2014
Phase: Phase 3
Study type: Interventional

The randomized, controlled trial is aiming at comparing local control rate between two surgical resections, barrier resection and local wide resection with 1cm or equivalent normal tissues. This is based on the fact that the goal of local surgical treatment is to remove the tumor with negative margin and best functional outcome, but there is a lack of standard principle of surgery. Some surgical oncologists recommended enlarging surgical field in which case the associated muscle was removed from origin to insertion, the previous surgical scar and radiation field were also grossly remove, though there would be extra trauma and unacceptable function impairment, they believe that patients would benefit from "big operations". Most other surgeons would perform a sarcoma resection through normal tissues, and reported a fair local control as long as a negative margin was obtained. As reported by various authors, recurrent STSs are associated with higher risk to develop further recurrence as compared to primary STSs, thus, efforts should focus on this category of STSs to improve outcome.

NCT ID: NCT02012699 Recruiting - Breast Cancer Clinical Trials

Integrated Cancer Repository for Cancer Research

iCaRe2
Start date: November 1, 2013
Phase:
Study type: Observational [Patient Registry]

The iCaRe2 is a multi-institutional resource created and maintained by the Fred & Pamela Buffett Cancer Center to collect and manage standardized, multi-dimensional, longitudinal data and biospecimens on consented adult cancer patients, high-risk individuals, and normal controls. The distinct characteristic of the iCaRe2 is its geographical coverage, with a significant percentage of small and rural hospitals and cancer centers. The iCaRe2 advances comprehensive studies of risk factors of cancer development and progression and enables the design of novel strategies for prevention, screening, early detection and personalized treatment of cancer. Centers with expertise in cancer epidemiology, genetics, biology, early detection, and patient care can collaborate by using the iCaRe2 as a platform for cohort and population studies.

NCT ID: NCT01920516 Recruiting - Metastatic Melanoma Clinical Trials

Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment

ILI
Start date: July 2013
Phase:
Study type: Observational

In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic and the survival in this group may be prolonged. In-transit melanoma metastases are often confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion (ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma and are generally well tolerated. ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69% for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these parameters potentially having an effect on outcome. ILP & ILI are used primarily as palliative options when excision of in-transit metastases is unfeasible but can be used as an adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has been shown to substantially decrease the rates of severe local toxicity while maintaining complete response rates, but overall response rate is reduced. Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease is associated with similar complete response rates but lower toxicity than ILI for Lower limbs E disease and with different physiologic sequelae despite comparable methods. The Upper limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently performed, which suggests a potential for further optimization of drug dosing for Upper limbs ILI. Regional therapy is an excellent therapeutic modality for disease limited to a limb and furthermore serves as an excellent model for scientific investigation, both clinical and translational. In this study we want to collect data on isolated limb infusion of chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the arm or leg that cannot be removed by surgery.

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: NCT01831609 Recruiting - Sarcoma Clinical Trials

Biomarker Analysis of Solid Cancers Such as Gastrointestinal Cancer

Start date: August 31, 2011
Phase:
Study type: Observational

To prospectively collect ascites, pleural fluid, circulating tumor cells and derived primary cultures from metastatic cancer patients. The specimens will be analyzed using DNA/RNA/proteomic approaches.

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: NCT01780779 Recruiting - Osteosarcoma Clinical Trials

Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults

FUBEO
Start date: June 2009
Phase: N/A
Study type: Observational

The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery. Second purpose : to define apparent diffusion coefficient value of the bone sarcoma. Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.

NCT ID: NCT01772771 Recruiting - Melanoma Clinical Trials

Molecular Testing for the MD Anderson Cancer Center Personalized Cancer Therapy Program

Start date: March 1, 2012
Phase:
Study type: Observational

This study performs standardized testing of tumor tissue samples to learn which genes are mutated (have changed) in order to provide personalized cancer therapy options to cancer patients at MD Anderson. This may help doctors use testing information on tumors to identify clinical trials that may be most relevant to patients. Researchers may also use the information learned from this study to develop a database of the different kinds of mutations in cancer-related genes.