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Активно (без набиране) Фаза 1

Personalized NeoAntigen Cancer Vaccine w RT Plus Pembrolizumab for Patients With Newly Diagnosed GBM

Glioblastoma

This research study is studying a new type of vaccine as a possible treatment for patients with glioblastoma. This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the intervention to use for further studies. "Investigational" means that the intervention is being studied and that research doctors are trying to find more about it. It also means that the FDA (U.S. Food and Drug Administration) has not approved the Personalized NeoAntigen Cancer Vaccine for any use in patients, including people with glioblastoma. The purpose of the initial study cohort (Cohort 1) is to determine if it is possible to make and administer safely a vaccine against glioblastoma by using information gained from specific characteristics of the participants tumor. It is known that glioblastomas have mutations (changes in genetic material) that are specific to an individual patient's tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the body fight any tumor cells that could cause the glioblastoma to come back in the future. Three additional cohorts (1a, 1b, \& 1c) were added to the study following completion of accrual to the original study cohort (cohort 1). Each new cohort receives NeoVax and radiation therapy as administered to cohort 1 and will also receive pembrolizumab: cohort 1a patients will start pembrolizumab w/in 2 weeks after start of RT, and continue every 3 weeks for up to 2 years; cohort 1b patients will start pembrolizumab 2-4 weeks after completion of NeoVax priming, and continue every 3 weeks for up to 2 years; cohort 1c patients will receive a single dose of pembrolizumab administered within 2 weeks after start of RT, re-start 2-4 weeks after completion of NeoVax priming, and continue every 3 weeks for up to 2 years. The rationale for adding these new cohorts is: 1) to assess the safety and feasibility of NeoVax when administered with pembrolizumab; and 2) to determine if the timing of anti-PD-1 administration impacts the immunogenicity of NeoVax. An additional sub-study cohort (1d) is being added for patients whose tumor is MGMT-methylated. Cohort 1d will enroll patients with tumors for which the MGMT status is methylated or partially methylated; patients on cohort 1d will receive standard daily temozolomide during radiation and as adjuvant therapy for up to six cycles following completion of radiation therapy. The rationale for adding cohort 1d is to determine the safety and feasibility of NeoVax when administered with pembrolizumab and temozolomide.

Начало: 01.11.2014 Край: 01.02.2028 Възраст: от 18 г.

United States Dana-Farber Cancer Institute NCT02287428

Активно (без набиране)

Frequency and Complications of Major Orthopedic Procedures in Medicare Beneficiaries

Rheumatoid Arthritis Ankylosing Spondylitis

Background: \- Orthopedic procedures are common in the United States. These include joint replacement and spine surgeries. Researchers want to study data about these procedures over time. They want to see if treatment has gotten better. They also want to find ways to change the care that people get before and after they have these procedures. These changes may lower the risk of problems people can have during and after treatment. They may also improve people s results. Objectives: \- To study a series of questions about surgery, medicine, treatments, and outcomes for orthopedic procedures. Eligibility: \- Data from the U.S. Centers for Medicare and Medicaid Services from 1999 to 2015. Design: * Researchers will look at data for people ages 20-100. * No new participants will be used in this study. * The study will last 6 years.

Начало: 24.10.2014 Край: 31.05.2029 Възраст: 20–100 г.

United States National Institute of Arthritis and Musculoskeletal and NCT02281747

Активно (без набиране) Фаза 2

Compassionate Use of Metreleptin in Previously Treated People With Partial Lipodystrophy

Diabetes Lipodystrophy Hyperlipidemia

Background: \- Partial lipodystrophy can cause high blood fat levels and resistance to insulin. This can lead to health problems including diabetes. Researchers have found that the drug metreleptin improves health in people with this disease. Objective: \- To test the safety and effectiveness of metreleptin. Eligibility: * People age 6 months and older with partial lipodystrophy who * have received metreleptin through NIH studies and shown improvement AND * cannot get metreleptin other ways. Design: * Participants will come to NIH approximately every 6 months during year one, then every 1 2 years. Financial assistance may be available for travel within the U.S. * At visits, participants will get a supply of metreleptin to take home for daily injections, or it can be shipped to them inside the U.S. They will have: * plastic catheter placed in an arm vein. * blood tests, urine collection, and physical exam. * oral glucose tolerance test, drinking a sweet liquid. * ultrasound of the heart, liver, uterus, and ovaries. A gel and a probe are placed on the skin and pictures are taken of the organs. * echocardiogram, which takes pictures of the heart with sound waves. * Resting Metabolic Rate taken. A plastic hood is worn over the head while the oxygen they breathe is measured. * Participants will have up to 3 DEXA scan x-rays per year. * Participants may have: * annual bone x-rays. * liver biopsies every few years. A needle will be inserted into the liver to obtain a small piece. Participants will sign a separate consent for this. * Participants must be seen regularly by their local doctors and have blood tests at least every 3-6 months at home.

Начало: 14.10.2014 Край: 31.07.2027 Възраст: 6–98 г.

United States National Institute of Diabetes and Digestive and Kidney NCT02262806

Активно (без набиране)

A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer

Acute Lymphoblastic Leukemia Brain Tumor Hodgkin Lymphoma

Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed to destroy malignant cell lines, and normal tissue is not always spared. While early treatment- related organ specific toxicities are not always apparent, many childhood cancer survivors report symptoms that interfere with daily life, including exercise induced shortness of breath, fatigue and reduced capacity to participate in physical activity. These symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most commonly described in older adults; it indicates persons who are highly vulnerable to adverse health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors have at least one severe chronic health condition 30 years from diagnosis, why childhood cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons, and why they have mortality rates more than eight times higher than age-and-gender matched members of the general population. Frailty is a valuable construct because it can be distinguished from disability and co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability that identify individuals most at risk for adverse health outcomes. These investigators have recently presented data indicating that impaired fitness is present in survivors of childhood acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because frailty, characterized by a cluster of five measurements of physical fitness, is predictive of chronic disease onset, frequent hospitalization, and eventually mortality in both the elderly and in persons with chronic conditions. Using a frailty phenotype as an early predictor of later chronic disease onset will allow identification of childhood and adolescent cancer survivors at greatest risk for adverse health. An early indicator of those at risk for adverse health will allow researchers to test, and clinicians to provide, specific interventions designed to remediate functional loss, and prevent or delay onset of chronic health conditions. The investigators goals include characterizing physical frailty over a five year time span in a population of young adult survivors of childhood cancer, as well as assessing the association between frailty and the increase in the number and severity of chronic health conditions.

Начало: 08.10.2014 Край: 01.06.2027 Възраст: 18–45 г.

United States St. Jude Children's Research Hospital NCT02256137

Активно (без набиране)

Genetic Testing in Screening Patients With Stage IB-IIIA Non-small Cell Lung Cancer That Has Been or Will Be Removed by Surgery (The ALCHEMIST Screening Trial)

Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage II Lung Non-Small Cell Cancer AJCC v7 Stage IIA Lung Cancer AJCC v8 Stage IIB Lung Cancer AJCC v8 +3

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Начало: 26.09.2014 Край: 28.09.2026 Възраст: от 18 г.

Guam, Puerto Rico, United States National Cancer Institute (NCI) NCT02194738

Активно (без набиране)

Molecular Profiling in Tissue Samples From Patients With Cancer Who Are Exceptional Responders to Treatment

Malignant Neoplasm

This pilot research trial studies molecular profiling in tissue samples from patients with cancer who got better with treatment that didn't work for most other patients with the same disease. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to how well patients respond to treatment.

Начало: 24.09.2014 Край: 30.04.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT02243592

Активно (без набиране) Фаза 1

AZD9291 in Combination With Ascending Doses of Novel Therapeutics

Advanced Non Small Cell Lung Cancer

The purpose of this study is to determine the safety, tolerability and preliminary anti-tumour activity of AZD9291 when given together with AZD6094 or selumetinib in patients with EGFR mutation positive advanced lung cancer

Начало: 05.08.2014 Край: 31.12.2026 Възраст: 18–130 г.

Canada, Japan, Poland +5 AstraZeneca NCT02143466

Активно (без набиране)

Functional Snack Foods With Safflower Oil and Soy in Postmenopausal Women Having Metabolic Syndrome

Metabolic Syndrome Overweight

This research study is being done to help researchers develop new dietary options for menopausal women to maintain a healthy weight by developing more nutritious snacks that have health benefits. From this study, the researchers hope to gain understanding on how menopausal women with metabolic syndrome digest and absorb foods with safflower oil on its own and when combined with soy. The research team hypothesize that the two different types of pretzels may be processed by your body differently and that components in the pretzel snacks may be helpful for preventing diseases like obesity and cancer. Safflower oil and soybeans contain many natural chemicals that may benefit human health. However, this relationship is not well understood. This study will look at the impact of the pretzel snacks on your blood fat and glucose levels as well as a group of chemicals found in soy called "isoflavones". Isoflavones are natural chemicals found commonly in soybeans or foods made from them. Participants will be screened to determine if they qualify in meeting the study requirements. Participants cannot have a known allergy to dairy, soy, safflower oil, or wheat protein. Also, participants will be asked to stop eating legumes (beans, peas, soy protein, sprouts and peanuts) and to document the oils they eat for the entire 14 weeks of this study. The study will require five visits to the Ohio State University Clinical Research Center (CRC) which part of the Ohio State University's Center for Clinical and Translational Sciences. Once the investigators have determined that you qualify for this study and you decide to participate, you will be consuming three different pretzels each for one month, starting with a control pretzel. After the control pretzel treatment period, you will be randomly assigned (like the "flip of a coin") to start with one of the two pretzel groups (wheat or soy pretzel with safflower oil) for your first treatment period and then switch to the other safflower oil pretzel at your second treatment period.

Начало: 01.07.2014 Край: 10.04.2027 Възраст: 45–70 г.

United States Ohio State University NCT02199054

Активно (без набиране)

European Active Surveillance Study of LCS12

Contraception

This study is designed to investigate whether LCS12 is associated with an increased risk of unintended pregnancy compared to Mirena and to copper IUDs. The objective is to assess among new users the risks of certain events (e.g. contraceptive failure rate, ectopic pregnancy, uterine perforation, and PID) associated with the use of LCS12 compared with the established hormonal IUD Mirena, and compared with established copper IUDs during standard clinical practice. In addition, drug utilization patterns will be described.

Начало: 17.06.2014 Край: 01.12.2026 Възраст: до 39 г.

Germany Center for Epidemiology and Health Research, Germany NCT02146950

Активно (без набиране) Фаза 1

iC9-GD2-CAR-VZV-CTLs/Refractory or Metastatic GD2-positive Sarcoma and Neuroblastoma

Osteosarcoma Neuroblastoma

The purpose of this study is to find the largest safe dose of GD2-T cells (also called iC9-GD2-CAR-VZV-CTLs) in combination with a varicella zoster vaccine and lymohodepleting chemotherapy. Additionally, we will learn what the side effects of this treatment are and to see whether this therapy might help patients with advanced osteosarcoma and neuroblastoma. Because there is no standard treatment for recurrent/refractory osteosarcoma and neuroblastoma at this time or because the currently used treatments do not work fully in all cases, patients are being asked to volunteer to take part in a gene transfer research study using special immune cells. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that a new gene can be put into T cells that will make them recognize cancer cells and kill them. Investigators now want to see if a new gene can be put in these cells that will let the T cells recognize and kill sarcoma and neuroblastoma cells. The new gene is called a chimeric antigen receptor (CAR) and consists of an antibody called 14g2a that recognizes GD2, a protein that is found on sarcoma and neuroblastoma cells (GD2-CAR). In addition, it contains parts of the CD28 and OX40 genes which can stimulate T cells to make them live longer. Investigators have found that CAR-T cells can kill some of the tumor, but they don't last very long in the body and so the tumor eventually comes back. T cells that recognize the virus that causes chicken pox, varicella zoster virus (VZV), remain in the bloodstream for many years especially if they are stimulated or boosted by the VZV vaccine. Investigators will therefore insert the GD2-CAR gene into T cells that recognize VZV. These cells are called iC9-GD2-CAR-VZV-specific T cells but are referred to as GD2-T cells for simplicity.

Начало: 01.04.2014 Край: 31.10.2034

United States Baylor College of Medicine NCT01953900

Активно (без набиране)

The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease

Crohn Disease Ulcerative Colitis

The aim of the study is to determine, whether administration of VSL#3 (Original De Simone formulation) probiotic preparation can alter the bile acid metabolism in patients with inflammatory bowel disease.

Начало: 01.02.2014 Край: 01.12.2027

Czechia Charles University, Czech Republic NCT01765439

Активно (без набиране) Фаза 2/3

Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV

Acquired Immune Deficiency Syndrome (AIDS) HIV Infections

The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in children (age ≥ 4 weeks to \< 18 years) with HIV.

Начало: 16.01.2014 Край: 01.03.2027 Възраст: 4–17 г.

Argentina, South Africa, Thailand +4 Gilead Sciences NCT02016924

Активно (без набиране)

Upper Airway Microbial Development During the First Year of Life

Asthma

This study tests the hypothesis that an increase in pathogenic bacteria within the infant airway leads to increased airway inflammation, decreased airway function and ultimately airway obstruction throughout the first one to two years of life.

Начало: 01.01.2014 Край: 31.12.2026 Възраст: 1–1 г.

United States Indiana University NCT01978288

Активно (без набиране) Фаза 2

Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy

Rhabdomyosarcoma

This study will treat participants with newly diagnosed, low, intermediate and high risk rhabdomyosarcoma (RMS) using multi-modality risk-adapted therapy with standard or intensified dose chemotherapy, radiation and surgical resection. Intermediate and high risk participants will receive an additional 12 weeks (4 cycles) of maintenance therapy with anti-angiogenic chemotherapy. PRIMARY OBJECTIVE: * Estimate event-free survival for intermediate risk participants treated with vincristine, dactinomycin and cyclophosphamide with the addition of maintenance anti-angiogenic therapy. SECONDARY OBJECTIVES: * Estimate the false negative rate and incidence of additional positive lymph nodes in participants undergoing sentinel lymph node biopsy followed by limited nodal dissection. * Maintain a high local control rate in participants treated with surgery and/or limited volume proton and photon radiation without dose escalation. * Define the incidence and type of failure in participants who receive risk-adapted local therapy relative to the primary tumor volume. * Establish the feasibility of delivering 4 cycles of maintenance anti-angiogenic chemotherapy in intermediate and high risk patients following standard chemotherapy. * Estimate the event free survival for high risk patients receiving interval dose compressed therapy and maintenance anti-angiogenic therapy. * Define the incidence of CTC grade 3 and higher toxicities (and specific grade 1-2 toxicities) related to proton beam therapy.

Начало: 04.12.2013 Край: 01.06.2030 Възраст: до 21 г.

United States St. Jude Children's Research Hospital NCT01871766

Активно (без набиране)

Retrospective Review of Cachexia in Lung and Gastrointestinal Cancer Patients

Cachexia

The objective is to perform a retrospective chart review of patients with cachexia related to cancer in patients treated at UT Southwestern Medical Center and Parkland Hospital to evaluate the prognosis and practice patterns in management of cachexia and associated symptoms.

Начало: 26.11.2013 Край: 18.03.2027 Възраст: 18–99 г.

University of Texas Southwestern Medical Center NCT03606317

Активно (без набиране)

PET Avidity in Cachexia-Inducing Lung and Gastrointestinal Tumors

Cachexia; Cancer

PET has an established role in the initial staging of patients with newly diagnosed lung and gastrointestinal tumors.PET avidity is described with both maximum and mean standardized uptake values.Malignant cells have increased activity on PET, defined as the standardized uptake value (SUV), with increased uptake of FDG in tumor due to elevated levels of GLUT receptors, elevated intracellular levels of hexokinase and increased rates of glycolysis. However, there is a subset of patients with lung and gastrointestinal tumors that are not PET avid.These patients may present with clinically and systemically aggressive disease with a declining performance status and/or weight loss.

Начало: 26.11.2013 Край: 31.12.2027 Възраст: 18–99 г.

United States University of Texas Southwestern Medical Center NCT03568019

Активно (без набиране)

Comprehensive Nano - Post Market Clinical Follow-Up Study

Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Revision +1

This data collection project is intended to provide clinical outcomes data to engineering, marketing as well as fulfill the post market surveillance requirements of various regulatory authorities. The study will be a prospective and one-arm.

Начало: 30.10.2013 Край: 31.07.2030 Възраст: от 18 г.

Austria, Canada, South Korea +1 Zimmer Biomet NCT03423953

Активно (без набиране)

Technology to Assess Vulnerable Older Adults With Cancer and Their Caregivers

Cancer Solid Tumor Hematologic Malignancy

The goal of this study is to determine the feasibility, reliability, and validity of administering the Geriatric Assessment Tool using these two different computer based survey platforms, REDCap and Support Screen. The development of a computer based Geriatric Assessment Tool has the potential to improve research and clinical practice by providing an efficient user friendly means to collect and analyze data for geriatric oncology patients.

Начало: 15.05.2013 Край: 06.01.2027 Възраст: от 65 г.

United States City of Hope Medical Center NCT02041416

Активно (без набиране) Фаза 2

Irinotecan and Temozolomide in Combination With Existing High Dose Alkylator Based Chemotherapy for Treatment of Patients With Newly Diagnosed Ewing Sarcoma

Newly Diagnosed Ewing Sarcoma

The purpose of this study is to find out what effects, good and/or bad, the combination of irinotecan and temozolomide has on Ewing sarcoma. Irinotecan and temozolomide are chemotherapy drugs that are used very often to treat pediatric patients at MSKCC. The investigators have used these two drugs for many years to treat patients with Ewing sarcoma whose cancer has relapsed. For patients with newly diagnosed Ewing sarcoma the current standard of care at MSKCC is a five drug chemotherapy regimen in combination with surgery and/or radiation therapy. This standard regimen is called the EFT regimen. . Some patients with Ewing sarcoma do not have their cancer cured by the chemotherapy and surgery/radiation therapy. This study adds the chemotherapy drugs called irinotecan and temozolomide to the standard EFT regimen. The investigators are trying to improve the success of standard therapy by adding these drugs. The use of irinotecan and temozolomide in this study is experimental because they have not been used before in patients with newly diagnosed Ewing sarcoma. However the investigators have found these drugs to be effective in patients with relapsed Ewing sarcoma. It is not known if adding these two drugs will improve the outcomes of patients treated for Ewing sarcoma.

Начало: 01.05.2013 Край: 01.05.2027 Възраст: 1–40 г.

United States Memorial Sloan Kettering Cancer Center NCT01864109

Активно (без набиране) Фаза 4

Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator

GIST and CML

The purpose of this study is to allow continued use of imatinib in patients who are on imatinib treatment in a Novartis-sponsored, Oncology Clinical Development \& Medical Affairs (CD\&MA) study and are benefiting from the treatment as judged by the investigator.

Начало: 26.03.2013 Край: 24.04.2026 Възраст: до 100 г.

China, Finland, France +8 Novartis Pharmaceuticals NCT01742299

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