33 results for "Pediatric"

Pediatric Type 2 Diabetes Mellitus and the effects of Lixisenatide

This study is to establish a safe dose for lixisenatide in children and adolescents of different age-groups and to understand whether lixisenatide has beneficial effects on Type 2 Diabetes Mellitus in children and adolescents.

At present, metformin and insulin are the only drugs with regulatory approval in most countries for the treatment of pediatric diabetes. Because approximately half of youth with Type 2 Diabetes Mellitus fail to maintain glycemic control when treated with metformin either alone or in conjunction with lifestyle interventions, insulin therapy is often required soon after diagnosis. Thus, there is a need for more treatment options for children and adolescents with Type 2 Diabetes Mellitus.

Pediatric Type 2 Diabetes Mellitus and the effects of Alogliptin

This study is evaluating effectiveness and safety of a medication in children and teenagers diagnosed with Type 2 Diabetes who are experiencing poor glucose and HbA1c control.

Premature Infants at Risk of Bronchopulmonary Dysplasia and the effects of Sildenafil

This study is testing a medication to learn more about the safety, potential side effects, dosing, and effectiveness when given to premature infants who are at risk for developing a condition called Bronchopulmonary Dysplasia (BPD). Additionally, this study is testing the medication to reduce the risk of developing BPD in premature infants.

While some doctors may use this medication to treat infants with BPD, the Food and Drug Administration (FDA) has not approved it for this use because the ability of the medication to effectively treat BPD has not been demonstrated in this population. The medication is approved, by the FDA, for use in adults to treat a disease that causes high blood pressure in the lungs. However, whether this medication helps premature infants at risk for BPD is not known. The results of this study could help us find the safest and most helpful doses of the medication to give to premature infants to prevent BPD.

AALL1331: Pediatric B-Cell Acute Lymphoblastic Leukemia and the Effects of Blinatumomab

This randomized phase III trial compares how well blinatumomab works compared with standard combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that has returned after a period of improvement (relapsed). Monoclonal antibodies, such as blinatumomab, can block cancer growth by finding cancer cells and helping to kill them or carrying cancer-killing substances to them. It is not yet known whether standard combination chemotherapy is more effective than blinatumomab in treating relapsed B-cell acute lymphoblastic leukemia.

AHEP1531: Cisplatin and Combination Chemotherapy for Hepatoblastoma or Liver Cancer After Surgery

This partially randomized Phase II/III trial studies how well Cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as Cisplatin, Doxorubicin, Fluorouracil, Vincristine sulfate, Carboplatin, Etoposide, Irinotecan, Sorafenib, Gemcitabine and Oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy after surgery may kill more tumor cells.

APEC1621: Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders and Targeted Therapy

This screening and multi-sub-study phase II trial studies how well treatment that is directed by genetic testing works in pediatric patients with solid tumors, non-Hodgkin lymphomas, or histiocytic disorders that have progressed following at least one line of standard systemic therapy and/or for which no standard treatment exists that has been shown to prolong survival. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with genetic changes or abnormalities (mutations) may benefit more from treatment which targets their tumor's particular genetic mutation, and may help doctors plan better treatment for patients with solid tumors or non-Hodgkin lymphomas.

AGCT1531: Active Surveillance, Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Germ Cell Tumors

This partially randomized phase III trial studies how well active surveillance, bleomycin, carboplatin, etoposide, or cisplatin work in treating pediatric and adult patients with germ cell tumors. Active surveillance may help doctors to monitor subjects with low risk germ cell tumors after their tumor is removed. Drugs used in chemotherapy, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

ACCL1333/CV185-155: ALL or Lymphoma (T or B Cell) and the Effects of Apixaban for Thromboembolism Prevention

To compare the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on the composite endpoint of adjudicated non-fatal deep vein thrombosis (DVT, including asymptomatic and symptomatic), pulmonary embolism (PE), and cerebral venous sinus thrombosis (CSVT); and venous thrombosis (VTE) -related-death during 25-28 days of open-label treatment in pediatric subjects (1 to < 18 years) with newly diagnosed ALL or lymphoma (T or B cell), a functioning Central Venous Access Device(CVAD) and receiving pegylated L-asparaginase during chemotherapy induction and to assess the effect of prophylactic oral or enteric apixaban versus no administration of systemic prophylactic anticoagulant during induction chemotherapy, on adjudicated major bleeding events during 25-28 days of open-label treatment.

ALTE05N1: Long-Term Follow-Up of Patients Who Have Participated in Children's Oncology Group Studies

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

AGCT1532: Accelerated vs Standard BEP Chemotherapy for Intermediate and Poor-risk Metastatic Germ Cell Tumors (P3BEP)

The purpose of this study is to determine whether accelerated BEP chemotherapy is more effective than standard BEP chemotherapy in males with intermediate and poor-risk metastatic germ cell tumors. Bleomycin, Etoposide, Cisplatin (BEP) administered 3-weekly x 4 remains standard 1st line chemotherapy for intermediate- and poor-risk metastatic germ cell tumors (GCTs). Cure rates are over 90% for good-risk disease, 85% with intermediate-risk, and about 70% for poor-risk disease. Previous strategies to improve first-line chemotherapy have failed to improve cure rates and were more toxic than BEP. New strategies are needed for patients with intermediate and poor-risk disease. BEP is accelerated by cycling Cisplatin and etoposide 2-weekly instead of 3-weekly. The Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) is conducting a trial comparing accelerated BEP with standard BEP. The aim of this study is to determine if accelerated BEP is superior to standard BEP as first-line chemotherapy for intermediate and poor risk metastatic GCTs.

ALTE16C1: Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors

This research trial studies saliva, semen, and blood samples to determine effects of chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes fertility problems and to learn more about the long term effects.

AREN1721: Axitinib and Nivolumab in Treating Unresectable or Metastatic TFE/Translocation Renal Cell Carcinoma

This phase II trial studies how well axitinib and nivolumab works in treating participants with TFE/translocation renal cell carcinoma that cannot be removed by surgery or has spread to other places in the body. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving axitinib and nivolumab may work better in treating participants with TFE/translocation renal cell carcinoma.

ALTE1631: Web-Based Physical Activity Intervention in Children and Adolescents with ALL in First Remission

This randomized clinical trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with newly diagnosed Acute Lymphoblastic Leukemia that shows a decrease in or disappearance of signs and symptoms. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.

WF-10217: Work Ability in Young Adult Survivors (WAYS)

To document levels of labor force participation, occupation, educational attainment, and financial toxicity following cancer treatment in YA cancer survivors aged 25-34 years. This observational, cross-sectional study will recruit 200 YA survivors through the Wake Forest National Cancer Institute Community Oncology Research Program (NCORP) Research Base (WF NCORP RB). Data will be collected using a web-based interface and will capture physical, psychosocial and cognitive late effects; work ability; work-related outcomes, including labor force participation, occupation, work place characteristics, and educational attainment; survivor characteristics; and cancer diagnosis/treatment information (from clinical records). We will evaluate the relationships among these measures using the theoretical framework to guide statistical analysis.

AAML1531: AML in Down Syndrome and the Effects of Cytaribine, Daunorubicin Hydrochloride, Thioguanine

This phase III trial studies response-based chemotherapy in treating newly diagnosed acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Response-based chemotherapy separates patients into different risk groups and treats them according to how they respond to the first course of treatment (Induction I). Response-based treatment may be effective in treating acute myeloid leukemia or myelodysplastic syndrome in younger patients with Down syndrome while reducing the side effects.

AALL1631: Imatinib Mesylate and Combination Chemotherapy in Newly Diagnosed Philadelphia Chromosome + ALL

This randomized phase III trial studies how well imatinib mesylate and combination chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving imatinib mesylate and combination chemotherapy may work better in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia.

ANBL1821: Irinotecan Hydrochloride, Temozolomide, and Dinutuximab ± Eflornithine for Relapsed or Refractory Neuroblastoma

This Phase II trial studies how well Irinotecan hydrochloride, Temozolomide, and Dinutuximab work with or without Eflornithine in treating patients with Neuroblastoma that has come back or that isn't responding to treatment. Drugs used in chemotherapy, such as Irinotecan hydrochloride and Temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as Dinutuximab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Eflornithine blocks the production of chemicals called polyamines that are important in the growth of cancer cells. Giving Eflornithine with Irinotecan hydrochloride, Temozolomide, and Dinutuximab, may work better in treating patients with relapsed or refractory Neuroblastoma.

AREN03B2: Study of Kidney Tumors in Younger Patients

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

AALL1621: Acute Lymphocytic Leukemia and the Effects of Low Dose Inotuzumab Ozogamicin

The goal of this clinical research study is to learn if inotuzumab ozogamycin can help to control the disease in participants with acute lymphocytic leukemia (ALL). The safety of this treatment will also be studied.

AALL1131: Chemotherapy in Treating Young Patients with High-Risk B ALL and Ph-like Sensitive Mutations

This randomized phase III trial studies how well combination chemotherapy works in treating young patients with newly diagnosed B acute lymphoblastic leukemia that is likely to come back or spread, and in patients with Philadelphia chromosome (Ph)-like tyrosine kinase inhibitor (TKI) sensitive mutations. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) and giving the drugs in different doses and in different combinations may kill more cancer cells.

AHOD1331: Brentuximab Vedotin and Chemotherapy in Treating Stage IIB or Stage IIIB-IVB Hodgkin Lymphoma

This randomized phase III trial studies brentuximab vedotin and combination chemotherapy to see how well they work compared to combination chemotherapy alone in treating children and young adults with stage IIB or stage IIIB-IVB Hodgkin lymphoma. Combinations of biological substances in brentuximab vedotin may be able to carry cancer-killing substances directly to Hodgkin lymphoma cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known if combination chemotherapy is more effective with or without brentuximab vedotin in treating Hodgkin lymphoma.

ANHL12P1: Brentuximab Vedotin or Crizotinib and Chemotherapy in Treating Anaplastic Large Cell Lymphoma

This partially randomized phase II trial studies how well brentuximab vedotin or crizotinib and combination chemotherapy works in treating patients with newly diagnosed stage II-IV anaplastic large cell lymphoma. Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Crizotinib and methotrexate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether brentuximab vedotin and combination chemotherapy is more effective than crizotinib and combination chemotherapy in treating anaplastic large cell lymphoma.

ARST1431: Combination Chemotherapy with or without Temsirolimus for Intermediate-Risk Rhabdomyosarcoma

This randomized phase III trial studies how well combination chemotherapy (vincristine sulfate, dactinomycin, cyclophosphamide alternated with vincristine sulfate and irinotecan hydrochloride) works compared to combination chemotherapy plus temsirolimus in treating patients with rhabdomyosarcoma (cancer that forms in the soft tissues, such as muscle), and has an intermediate chance of coming back after treatment (intermediate risk). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Combination chemotherapy and temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether combination chemotherapy or combination chemotherapy plus temsirolimus is more effective in treating patients with intermediate-risk rhabdomyosarcoma.

APEC14B1: Project - Every Child for Younger Patients with Cancer

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

ACNS1422: Reduced Craniospinal RT and Chemotherapy for Newly Diagnosed WNT-Driven Medulloblastoma

This phase II trial studies how well reduced doses of radiation therapy to the brain and spine (craniospinal) and chemotherapy work in treating patients with newly diagnosed type of brain tumor called WNT)/Wingless (WNT)-driven medulloblastoma. Recent studies using chemotherapy and radiation therapy have been shown to be effective in treating patients with WNT-driven medulloblastoma. However, there is a concern about the late side effects of treatment, such as learning difficulties, lower amounts of hormones, or other problems in performing daily activities. Radiotherapy uses high-energy radiation from x-rays to kill cancer cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, vincristine sulfate, cyclophosphamide and lomustine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving reduced craniospinal radiation therapy and chemotherapy may kill tumor cells and may also reduce the late side effects of treatment.

ANBL1232: Response and Biology-Based Risk Factor-Guided Therapy in Treating Non-High-Risk Neuroblastoma

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

ANBL00B1: Biomarkers in Tumor Tissue Samples for Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

This research trial studies biomarkers in tumor tissue samples from patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

ALTE1621: Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn't get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can't pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.

ALTE11C2: Effects of Dexrazoxane on Biomarkers Associated with Cardiomyopathy After Cancer Treatment (HEART)

This clinical trial studies the effects of dexrazoxane hydrochloride on biomarkers associated with cardiomyopathy and heart failure after cancer treatment. Studying samples of blood in the laboratory from patients receiving dexrazoxane hydrochloride may help doctors learn more about the effects of dexrazoxane hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

Assessing Compliance with Mercaptopurine Treatment in Younger Patients with ALL in First Remission

This randomized phase III trial studies compliance to a mercaptopurine treatment intervention compared to standard of care in younger patients with acute lymphoblastic leukemia in remission. Assessing ways to help patients who have acute lymphoblastic leukemia to take their medications as prescribed may help them in taking their medications more consistently and may improve treatment outcomes.

LOXO-EXT-17005: Phase 1/2 Study of LOXO-195 in Patients with Previously Treated NTRK Fusion Cancers

This is a Phase 1/2, multi-center, open-label study designed to evaluate the safety and efficacy of LOXO-195 when administered orally to patients age ≥ 1 month and older with NTRK fusion cancers treated with a prior TRK inhibitor.

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JAZZ 201: Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

This is a study comparing the Defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

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SYNCARDIA 50cc (TAH-T)

The objective of the study is to evaluate whether the 50cc TAH-t can safely support, and provide probably benefit to, transplant-eligible pediatric patients (aged 10-18 years) and adult patients (aged 19-75 years) at imminent risks of death from biventricular failure without experiencing permanent disabling, stroke-related deficits.