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NCT ID: NCT01666015 Terminated - Cancer Clinical Trials

Exercise in Pediatric Autologous Stem Cell Transplant Patients

SCORE
Start date: June 2012
Phase: N/A
Study type: Interventional

Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized Controlled Trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. The Secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle. Methods Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, NK cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date. Discussion We expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.

NCT ID: NCT01663766 Terminated - Clinical trials for Myelodysplastic Syndrome

Phase I Study of Milatuzumab for Graft Versus Host Disease

Start date: December 2013
Phase: Phase 1
Study type: Interventional

This study will assess the safety and tolerability of milatuzumab (IMMU-115) when added to a standard regimen to prevent Graft vs. Host Disease (GVHD) in patients with hematologic malignancies undergoing stem cell transplant.

NCT ID: NCT01662284 Terminated - Clinical trials for Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer

Study of 124I-NM404 in Advanced Solid Malignancies

Start date: July 2012
Phase:
Study type: Observational

The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.

NCT ID: NCT01659658 Terminated - Clinical trials for Relapsed or Refractory Systemic Light Chain Amyloidosis

Study of Dexamethasone Plus IXAZOMIB (MLN9708) or Physicians Choice of Treatment in Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis

Start date: December 26, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to provide continued access of ixazomib and/or other study medications and to continue collecting relevant safety data to monitor participant's safety, determine whether dexamethasone plus IXAZOMIB improves hematologic response, 2-year vital organ (that is, heart or kidney) deterioration and mortality rate versus a physician's choice of a chemotherapy regimen in participants diagnosed with relapsed or refractory systemic light chain (AL) amyloidosis.

NCT ID: NCT01659099 Terminated - Clinical trials for Diffuse Large B Cell Lymphoma CD20 Positive

GA In NEwly Diagnosed Diffuse Large B Cell Lymphoma

GAINED
Start date: September 2012
Phase: Phase 3
Study type: Interventional

This study is designed to investigate: - the interest of a new monoclonal antibody (GA101)versus rituximab - the interest of PET to identify early responders Patients will receive either rituximab (standard treatment), either GA101 (study treatment), according to the randomization arm. The monoclonal antibody will be associated to a chemotherapy: CHOP or ACVBP according to site's choice.A PET scan will be done before inclusion, after 2 chemotherapy cycles, and after 4 chemotherapy cycles, to identify early patients responders, for who consolidation with ASCT is not required.

NCT ID: NCT01658332 Terminated - Clinical trials for Stage IV Non-small Cell Lung Cancer

Circulating Tumor Cells in Lung Cancer

CIRCUBRONCH
Start date: June 2012
Phase: N/A
Study type: Interventional

TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH) BACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor. PRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV). SECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis. STUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers. Duration of the inclusions: 54 months. Duration of the study: 66 months. PROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood. SAMPLE SIZE : 200 patients STATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.

NCT ID: NCT01658007 Terminated - Clinical trials for Recurrent Adult Lymphoblastic Lymphoma

Pilot Study Of Sirolimus Plus Multiagent Chemotherapy For Relapsed/Refractory Acute Lymphoblastic Leukemia/Lymphoma

SIR-MO-1101
Start date: August 2012
Phase: Early Phase 1
Study type: Interventional

The investigators want to learn about treating relapsed/refractory lymphoblastic leukemia and lymphoma with a drug called sirolimus. The investigators are using sirolimus along with other cancer drugs that are often given to patients with relapsed leukemia and lymphoma. The main purpose of this study is to determine if sirolimus can be given safely in combination with standard drugs used to treat relapsed lymphoblastic leukemia/lymphoma.

NCT ID: NCT01657435 Terminated - Osteoarthritis Clinical Trials

28mm Ceramic-on-Ceramic Total Hip Replacement Study

COC28
Start date: May 1, 2012
Phase:
Study type: Observational

This study is intended to gather medium (0-5 years) and long-term (6-10 years) information regarding the performance and safety of the commercially available Ceramax™ Ceramic on Ceramic Total Hip System. This is a two-phased study consisting of a clinical follow-up phase and a clinical outcomes phase. In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually. In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.

NCT ID: NCT01656577 Terminated - Placebo Clinical Trials

Pexacerfont for Stress-induced Food Craving

Start date: June 2012
Phase: Phase 0
Study type: Interventional

Background: - Stress can cause people to give in to temptations to eat less healthily. People who are on weight loss diets often have problems sticking to their diets when they are stressed. Some tests have shown that the drug pexacerfont can help reduce stress-related seeking of high-calorie foods. However, it has not been tested on reducing food craving. Researchers want to test pexacerfont on people who are on diets to see if it can reduce stress-related food cravings. Objectives: - To see if pexacerfont can help reduce stress-induced food cravings. Eligibility: - Individuals between 21 and 65 years of age who are on a diet to control their weight. Design: - Participants will be screened with a physical exam and medical history. This study requires seven visits over about 35 days. - Participants will take either pexacerfont or placebo pills during the study. They will have three pills every morning. They will record video of themselves taking the pills every day. - Every evening, participants will fill out a questionnaire. It will ask questions about feelings and behaviors related to eating and food craving. - Participants will have regular study visits while taking the pills. The visits will involve questions about stressful situations and food cravings. One visit will involve a mildly stressful math test, followed by tasting of different foods. This test will look at whether pexacerfont can affect food preferences. Participants will provide blood and saliva samples as directed at these study visits. - Participants will have follow-up phone calls 1, 3, and 6 months after the end of the study.

NCT ID: NCT01655875 Terminated - Clinical trials for Pediatric Acute Myeloblastic Leukemia, Relapsed

AMD3100 for Sensitizing in Allogeneic Blood or Marrow Transplant for Chemotherapy Resistant Pediatric Acute Leukemia

BMTAMD3100
Start date: June 2012
Phase: Phase 1
Study type: Interventional

This study is for patients 2-21 years old who have acute leukemia that has not responded well to chemotherapy and will have a bone marrow transplant. This is a pilot (phase 1) study of AMD3100(also called Plerixafor, Mozobil). AMD3100 is given in combination with a standard pre-transplant conditioning regimen (total body irradiation, etoposide and cyclophosphamide). The conditioning regimen is the treatment that is given just before the transplant. This treatment kills leukemia cells as well as healthy bone marrow and immune cells. Researchers want to learn more about how AMD3100 affects acute leukemia cells. Blood and bone marrow samples from study participants will be collected to find out if AMD3100 is making patients' cells more sensitive to the conditioning regimen and to find out how it does this. The first six patients receive three daily doses (240 mcg/kg via IV). If it appears that three doses do not significantly increase the side effects of transplant conditioning, the investigators will give a second group of six patients five daily doses.