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Filter by:To carry out exploratory studies to determine if activity of this regimen correlates with tumor and patient associated markers of the EGF-R/mTOR pathway These markers may correlate with activity of this regimen and provide exploratory insights in to the mechanism of this treatment approach. Expression of the pathway components including EGF-R and phosphorylated EGF-R (p-EGF-R), ERK and p-ERK, Akt and p-Akt(T308 and S473), p70s6k and p-p70s6k, S6 and p-S6, HIF-1-alpha, p27 and 4E-BP1 will be assessed. Mutation and FISH analysis for EGF-R expression will also be performed on tumor samples. Biopsies will be obtained at the following times: pre-treatment, and after 4 weeks (one cycle) of treatment. If available, original diagnostic tissue may be submitted in place of the pre-treatment biopsy.
Patients with hematologic malignancies will receive myeloablative chemotherapy followed by stem cell rescue with bone marrow or hematopoietic peripheral blood stem cells collected by apheresis from a filgrastim- (G-CSF)-mobilized haploidentical related-donor, ie, hematopoietic peripheral blood stem cell transplant (HSCT).
Introduction. Despite adequate steroid therapy, a subpopulation of approximately 10% of asthmatics develops severe persistent airflow obstruction. It is now widely agreed that the latter is the consequence of a remodeling process of the airways, characterized by an increase in airway smooth muscle mass, mucus gland hypertrophy, increased thickness of the subepithelial basement membrane, extracellular matrix protein deposition, angiogenesis, fibroblast and myofibroblast accumulation. These phenomena are responsible for airway wall thickening and for decreased airway caliber leading to persistent airflow obstruction. Endothelin-1 (ET-1) is a small peptide, synthesized in the lung by airway epithelial and smooth muscle cells, as well as inflammatory cells. ET-1 induces bronchoconstriction, mediates eosinophils recruitment during allergic inflammation and contributes to airway remodeling by inducing fibroblasts and smooth muscle cells differentiation and proliferation. In a recent work from Inserm Unit 700, it has been shown that ET-1 was overexpressed in epithelial cells from severe asthmatic patients as compared to patients with less severe disease, and that ET-1 expression was strongly correlated with airway obstruction (measured by FEV1) and on bronchial biopsies with airway smooth muscle areas. In another study, we have shown that a polymorphism of the receptor for ET-1 was strongly associated with the degree of airway obstruction in a population of asthmatic patients. All these data suggest that inhibition of the ET-1 pathway could be a potential therapeutic option in patients with steroids refractory asthma and irreversible airway obstruction. Bosentan, a specific inhibitor of ET-1 receptors which is actually used in patients with pulmonary hypertension, improves survival and inhibits vascular remodeling. Aim and strategy. To study the impact on airway remodeling and clinical status of an antagonist of the endothelin receptors (Sitaxentan 100mg/day) over a 12-month period, in a prospective randomised placebo-controlled trial involving two parallel groups of 25 severe asthmatic patients with irreversible airflow obstruction (FEV1≤ 70% of predicted) . Various hallmarks of airway remodeling will be analyzed on bronchial biopsy specimens by immunohistochemistry and morphometry. These findings will be correlated with the results of pulmonary function tests. Twenty-five patients will be included in each group. Remodeling will be measured on bronchial biopsies performed during fiberoptic bronchoscopy at inclusion and after one year, by assessing smooth muscle area, submucosal fibroblasts count and basement membrane thickness. Every 3 months, bronchial obstruction (FEV1), clinical status, asthma exacerbations, steroids use, need for emergency care, asthma symptoms and quality of life will be assessed. Evaluation of airway inflammation will be assessed every 3 months by exhaled NO and induced sputum cytology. This proof of concept study will validate ET-1 as a new molecular target for treating airway remodeling in patients with severe asthma.
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
RATIONALE: Lenalidomide may stop the growth of cancer by blocking blood flow to the tumor. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving lenalidomide together with rituximab may be an effective treatment for B-cell non-Hodgkin lymphoma. PURPOSE: This phase I/II trial is studying the side effects and best dose of lenalidomide when given together with rituximab as maintenance therapy in treating patients with B-cell non-Hodgkin lymphoma.
This phase II trial is studying how well rituximab works in preventing acute graft-versus-host disease (GVHD) in patients undergoing a donor stem cell transplant for hematologic cancer. Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving a monoclonal antibody, rituximab, together with anti-thymocyte globulin, tacrolimus, and mycophenolate mofetil before and after the transplant may stop this from happening
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.
This study is being conducted to examine outcome measurements on patients who undergo surgery to removed a damage lumbar spine disc versus those that chose not to have surgery. These outcomes are based on patient responses to quality of life and pain questionnaires.
The current trial will explore the safety of flibanserin in combination with Selective Serotonin Reuptake Inhibitors or Norepinephrine Serotonin Reuptake Inhibitors in a representative population of women with depressive and possible concurrent anxiety symptomatology.