Randomized Phase 2 Trial Evaluating the Addition of the IGF-lR Monoclonal Antibody Ganitumab (AMG479, NSC#750008, IND#120449) to Multiagent Chemotherapy for Patients with Newly Diagnosed Metastatic Ewing Sarcoma

Neuroblastoma Classification Biology Studies

Inova Children's Hospital
3300 Gallows Road
Falls Church, VA 22042

A Children's Oncology Group Protocol for Collecting and Banking Osteosarcoma Specimens

The purpose of this study is to identify gene changes that cause DCM and gene differences that influence the development and severity of DCM. These genetic studies may identify a change in a gene that has already been linked with DCM, a change in a gene not previously associated with DCM, or these studies may identify a gene or genes that affect the development and severity of the DCM. With this knowledge we hope to have a better understanding of how genes and gene changes cause DCM.

The goal of this study is to evaluate the safety and efficacy of Amitiza (lubiprostone) in children with constipation. Even though traditional treatment of functional constipation in children is available and safe, for many patients it does not provide a satisfying improvement, prompting interest in other therapeutic strategies.

Since lubiprostone has been shown to increase the frequency of spontaneous bowel movements (SBMs) in both adults and children, further evaluation in well controlled studies in children is needed to demonstrate use in a paediatric population. Study requires use of an electronic diary nightly, 6 visits and 5 blood draws.

There are two equally important primary hypotheses, which will be tested in two independent parallel, randomized clinical trials.

One trial will test the primary hypothesis that intensive medical management differs from the combination of CEA and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.

One trial will test the primary hypothesis that intensive medical management differs from the combination of CAS and intensive medical management in preventing the primary endpoint in patients with high-grade asymptomatic carotid stenosis.

In both trials, the primary endpoint is stroke or death within 44 days after randomization or ipsilateral ischemic stroke thereafter at the 4-year time point of follow-up.

C-TRACT is a large, well-designed study of new treatments for vein damage caused by blood clots. The goal of the study is to understand whether new image-guided procedures (endovascular therapy or EVT) reduce the severity of Post-Thrombotic Syndrome (PTS) and improve quality of life. The long-term safety and costs of the EVT procedure(s) will also be considered. Volunteers will be randomly assigned (like the flip of a coin) to either high quality PTS care (lifestyle interventions, compression therapy, and medical therapy) or high quality PTS care AND endovascular therapy (stent placement to re-open blocked veins and, if needed, endovenous ablation to eliminate backflow in veins with leaky valves). After randomization, patients will be asked to return to their clinical research center for study visits at 2 Months, 4 Months, 6 Months, 12 Months, 18 Months, and 24 Months.