View clinical trials related to Carcinoma.
Filter by:The purpose of this study is to determine the safety, tolerability, and the highest dose of GC4419 that can be given to patients with squamous cell cancer of the head and neck who are receiving standard radiation therapy and chemotherapy. This study will also evaluate GC4419 for the following: - Effect on the incidence and severity of radiation induced oral mucositis; - Effect on the response rate of squamous cell cancer of the head and neck who are receiving radiation therapy and chemotherapy; - Total concentrations of GC4419 that can be achieved in the blood; - Changes in proteins and genetics associated with oral mucositis; - Impact on delayed toxicities of radiation (dry mouth and reduced ability to fully open the mouth); - Observe changes in genetic and molecular markers of oral mucositis; - Observe the usage of extra health resources (e.g., unplanned ER visits, feeding tube use, etc.) of study patients; - Assess the overall quality of life in study patients with oral mucositis.
This study is the first time that a new experimental drug called [18F]-SKI-249380 is being used in people. [18F]-SKI-249380 is not a therapeutic drug. [18F]-SKI-249380 is a drug that will be used with PET scanners to 'see' where [18F]-SKI-249380 goes in the body, after its injected. The researchers believe that scans with [18F]-SKI-249380 might be able to find tumors in patients. This study is being done to see how long [18F]-SKI-249380 stays in the blood, when it is given to people in tiny amounts by an injection into a vein in their arm, and to see where [18F]-SKI-249380 goes in the body. If the results of this trial are good, then the study doctors plan to use [18F]-SKI-249380 in another trial to see if scans with [18F]-SKI-249380 are better for finding tumors compared to the standard types of scans that doctors use.
This is a study to investigate the potential clinical benefit of refametinib when given in combination with sorafenib as first line treatment in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least partial response according to an objective criteria to evaluate tumor size based on contrast enhancement [modified response evaluation criteria in solid tumors (mRECIST)] assessed by external independent radiologists. Refametenib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib in combination with sorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib in combination with sorafenib improves the response rate in this patient population compared to historical results observed with the sorafenib only.
This is a study to investigate the potential clinical benefit of refametinib in patients with unresectable or metastatic HCC carrying a RAS mutation. The study will be conducted in 2 stages. Approximately 95 patients (15 at Stage 1/ 80 at Stage 2) will be accrued to this study to receive treatment. Stage 2 of the trial will only be conducted if at least 5 out of 15 patients at Stage 1 show at least confirmed partial response (PR) according to modified response evaluation criteria in solid tumors (mRECIST) assessed by central image review. Refametinib is an oral (i.e. taken by mouth) protein kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, refametinib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning. The primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. The aim is to show that the therapy with refametinib improves the response rate in this RAS mutation patient population.
This is a phase 2 study to see how useful, safe, and tolerable an investigational drug called ENMD-2076 is in treating patients with ovarian clear cell carcinomas. ENMD-2076 is an oral drug that works by blocking certain enzymes called Aurora A and tyrosine kinase from working. These enzymes are needed for cells to divide including cancer cells. ENMD-2076 also works by stopping the growth of new blood vessels which would provide the tumor with nutrients for it to grow. It is believed that by blocking Aurora A and tyrosine kinase enzymes from working and stopping new blood vessels from growing, the tumors may stop growing or shrink.
The presence of portal vein tumor thrombosis (PVTT)in patients with HCC is one of the most significant prognostic factors for poor prognosis, without treatment, their survival is less than 3 months. In the HCC patients who combined with PVTT, RT showed 50% of local control and about 10 months survival duration. Despite the standard treatment of the HCC combined with PVTT is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in those patients. Investigators previously reported the retrospective study that the scheduled interval TACE followed by RT for HCC combined with PVTT and 60% of the patients showed objective response without significant elevation of complication. It is reported that hyperthermia considered as the most valuable radiosensitizer in cancer treatment, theoretically. Based on those studies, we start this prospective study to evaluate the objective response and adverse event in the combination treatment of RT and hyperthermia after Transarterial chemoembolization (TACE) in the unresectable HCC patients who combined with PVTT.
1. Background 1.1. Hepatocellular carcinoma (HCC) HCC is the third most common cause of cancer death globally. It is also the second cause of cancer mortality in Korea, despite the incidence of HCC was fifth. The most important cause of this discrepancy is connected with the fact that the significant portion of the HCC is detected as unresectable status. 1.2. Standard treatment of the HCC At the point of HCC diagnosis, only 30% of the patients could receive standard curative treatment, like resection, liver transplantation, and radiofrequency ablation (RFA). Transcatheter arterial chemoembolization (TACE) has been shown in randomized trials to improve survival compared with symptomatic therapy alone, in the patients without macrovascular involvement, extrahepatic disease and tumor related symptoms. However, in the recent review of TACE, TACE might be contraindicate or not recommended in the patients who showed vascular tumor invasion, more than 10 cm size, poor portal blood flow and/or repeated poor response. Recently, Sorafenib, which is one of the target agents, showed survival advantage on unresectable HCC patients in two randomized study. In those study, sorafenib improved approximately three month overall survival increment, however, the median survival duration was only 10.7 months in experiment group (received sorafenib), and even 6.5 months in Asian-Pacific trial. Additionally, the possibility that sorafenib effect could be reduced in the patients had hepatitis B virus (HBV) was suggested in the subgroup analysis. 1.3 Radiation therapy (RT) for the HCC The use of RT in HCC is increased with the radiation technological advances. In the unresectable patients, RT showed 50 to 60% response rate with the dose response relationship. Recently, stereotactic body radiation therapy (SBRT) showed excellent local control and comparable survival rate in thoracic tumor. In the HCC, SBRT also showed 75 to 100% local control rate without significant elevation of the toxicities. One study reported that 24 to 54 Gy SBRT achieved 87% 1year local control and 17 months overall survival. The standard treatment of unresectable HCC is sorafenib, but Korean Liver Cancer Study Group (KLCSG) recommend RT as an option in localized unresectable HCC. Furthermore, Radiation Therapy Oncology Group (RTOG) started randomized trial to confirm the effect of SBRT in unresectable HCC (RTOG 1112). Investigators previously reported the retrospective result that the higher dose SBRT achieved 2 year overall survival 87.9% and local control 85% in the patient who showed less than 5 cm solitary HCC without portal vein involvement. Based on those studies, we start this prospective study to evaluate the effectiveness and adverse event of SBRT in the patients who had solitary 3 cm or less size HCC without extrahepatic lesion and vascular involvement.
The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with placebo on overall survival in subjects with advanced hepatocellular carcinoma who have received prior sorafenib.
The study aims to investigate patient characteristics of intermediate stage hepatocellular carcinoma patients treated with Nexavar and their distribution to different treatment groups as well as determining efficacy and safety parameters.
The project is based on a case-control study including cirrhotic patients with (200 cases) and without (400 controls) Hepatocellular carcinoma. The determination of sample sizes in proteomic or spectroscopic studies has to be adapted to the high dimensional setting. The proteomic analysis will be conducted by Clinical Innovation Proteomic Platform of Dijon. Two approaches will be used in the proteomic study: A global approach based on the comparison of proteomic spectra profiles obtained after mass spectrometry analysis (MALDI-TOF). The particularity of this study with regard to previous studies is : the procedures used to purify the sub proteomes (Five automated methods including depletion fractionation and purification will be applied), the qualification of the generated data with the introduction of quality controls, the high number of samples included in the study. The second approach BIA-MS (Biomolecular interaction analysis mass spectrometry) is targeted approach allows the capture, quantification and characterization of proteins. The quality controls allow to quantify the various variability sources and to validate that biological variability is higher than technical variability. All the samples will be treated and analyzed with the same protocols, 100 samples will be used to validate the marker and statistical models developed after analysis of the first 500 samples. The infra-red spectroscopy analysis will be conducted by MéDIAN team, CNRS UMR 6237 of Reims university. The first 300 samples after feature selection reference spectra, are classified into different classes by means of mathematical classification methods such as multivariate statistical processes of pattern recognition, neuronal networks, support vector machines and methods of case-based classification or machine learning, genetic algorithms or methods of evolutionary programming. The analysis of a second set of samples (300) will validate the different mathematical classification methods developed. In the global study the investigators will unravel the relationship between proteomic, spectroscopic and metabolic/nutritional data. The description of these relationships will use canonical analysis and multi-block analysis in a more general extent. The goal of these methods is to explore relationships that may exist between several groups of quantitative variables observed on the same set of individuals.