Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
National Cancer Institute (NCI)
Background: * Worldwide, hepatocellular carcinoma (HCC) is the fifth most common malignancy with a median survival of 6-9 months. The Study of Heart and Renal Protection (SHARP) study established Sorafenib as a standard consideration in this disease and set the bar for future studies of systemic therapy. There is no standard therapy for patients whose disease has progressed despite Sorafenib therapy. * TRC105 is a chimeric, anti-angiogenic monoclonal antibody that binds CD105, a transmembrane receptor overexpressed by proliferating endothelial cells. TRC105 binds to CD105-expressing endothelial cells and mediates growth inhibition, apoptosis and antibody-dependent cell-mediated cytotoxicity (ADCC). Objectives: Primary: -To evaluate time to tumor progression (TTP) for TRC105 in HCC. Secondary: * To evaluate safety of TRC105 in HCC. * To evaluate the immunogenicity of TRC105 as measured by human antichimeric antibody (HACA) and human antimouse antibody formation. * To evaluate anti-tumor response as determined by standard and European Association for the Study of the Liver (EASL) -modified Response Evaluation Criteria in Solid Tumors (RECIST) response criteria. * To perform correlative studies assessing potential biomarkers of response to TRC105. Eligibility: * Histologically or cytologically confirmed diagnosis of HCC. * Childs-Pugh A or B (7 points) cirrhosis only is allowed. * Patients must have disease that is not amenable to potentially curative resection. * Patients must have progressed on or been intolerant of prior sorafenib therapy. * No history of bleeding varices (unless subsequent liver transplant). All patients must have had endoscopic evaluation within 6 months of starting study. * No history of bleeding varices in previous 1 year (unless subsequent liver transplant). No anti-coagulation (except low-dose aspirin). Design: * This is a single-arm phase II study of TRC105 in patients with HCC. * TRC105 will be administered as an intravenous infusion every two weeks. Patients will be re-staged every 8 weeks. * The primary endpoint of the study will be Time to Tumor Progression (TTP). The primary purpose of this study is to evaluate the ability of TRC105 as a second line treatment to improve upon the time to progression (TTP) of patients with refractory HCC.
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
