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Neuroblastoma Maintenance Therapy Trial

Multiple Cancer Types

Difluoromethylornithine (DFMO) will be used in an open label, single agent, multicenter, study for patients with neuroblastoma in remission. In this study subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg / m2 250 mg / m2 BID (strata 1, 2, 3, and 4) OR 2500 mg / m2 BID (stratum 1B) on each day of study. This study will focus on the use of DFMO in high risk neuroblastoma patients that are in remission as a strategy to prevent recurrence.
Endocrine, Neuroblastoma (Pediatrics), Neuroendocrine, Pediatrics
II
Pastakia, Devang
NCT02679144
VICCPED16157

Multiparametric MRI as a Non-Invasive Biomarker of the Tumor Microenviroment in Breast Cancer

Breast

Breast
N/A
Kennedy, Laura
NCT04803084
VICCBRE20104

Managed Access Program (MAP) to provide alpelisib (BYL719) for patients with PIK3CA-Related Overgrowth Spectrum (PROS)

Pediatrics

Pediatrics
N/A
Zarnegar-Lumley, Sara
NCT04085653
VICCPED1985

An Open Label, Expanded Access Protocol using 131I-Metaiodobenzylguanidine (131I-MIBG) Therapy in Patients with Refractory Neuroblastoma, Pheochromocytoma, or Paraganglioma

Multiple Cancer Types

Neuroblastoma (Pediatrics), Pediatric Solid Tumors
N/A
Kitko, Carrie
NCT01590680
VICCPED1249

A Study to Compare Treatment with the Drug Selumetinib Alone versus Selumetinib and Vinblastine in Patients with Recurrent or Progressive Low-Grade Glioma

This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma.
Not Available
III
Esbenshade, Adam
NCT04576117
COGACNS1931

Nivolumab with or without Azacitidine in Treating Patients with Recurrent Resectable Osteosarcoma

Multiple Cancer Types

This phase I / II trial studies the best dose and side effects of azacitidine and how well it works with or without nivolumab in treating patients with osteosarcoma that has come back (recurrent) and can be removed by surgery (resectable). 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. Drugs used in chemotherapy, such as azacitidine, 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 nivolumab and azacitidine together may work better compared to nivolumab alone in treating patients with osteosarcoma.
Phase I, Sarcoma
I/II
Borinstein, Scott
NCT03628209
VICCPED2012

A Study to Compare Standard Chemotherapy to Therapy with CPX-351 and / or Gilteritinib for Patients with Newly Diagnosed AML with or without FLT3 Mutations

Multiple Cancer Types

This phase III trial compares standard chemotherapy to therapy with liposome-encapsulated daunorubicin-cytarabine (CPX-351) and / or gilteritinib for patients with newly diagnosed acute myeloid leukemia with or without FLT3 mutations. Drugs used in chemotherapy, such as daunorubicin, cytarabine, and gemtuzumab ozogamicin, 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. CPX-351 is made up of daunorubicin and cytarabine and is made in a way that makes the drugs stay in the bone marrow longer and could be less likely to cause heart problems than traditional anthracycline drugs, a common class of chemotherapy drug. Some acute myeloid leukemia patients have an abnormality in the structure of a gene called FLT3. Genes are pieces of DNA (molecules that carry instructions for development, functioning, growth and reproduction) inside each cell that tell the cell what to do and when to grow and divide. FLT3 plays an important role in the normal making of blood cells. This gene can have permanent changes that cause it to function abnormally by making cancer cells grow. Gilteritinib may block the abnormal function of the FLT3 gene that makes cancer cells grow. The overall goals of this study are, 1) to compare the effects, good and / or bad, of CPX-351 with daunorubicin and cytarabine on people with newly diagnosed AML to find out which is better, 2) to study the effects, good and / or bad, of adding gilteritinib to AML therapy for patients with high amounts of FLT3 / ITD or other FLT3 mutations and 3) to study changes in heart function during and after treatment for AML. Giving CPX-351 and / or gilteritinib with standard chemotherapy may work better in treating patients with acute myeloid leukemia compared to standard chemotherapy alone.
Leukemia, Pediatric Leukemia, Pediatrics
III
Zarnegar-Lumley, Sara
NCT04293562
COGAAML1831

Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer

Multiple Cancer Types

This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating patients with stage IV non-squamous non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as pemetrexed and carboplatin, 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. It is not yet known whether giving first-line pembrolizumab followed by pemetrexed and carboplatin with or without pembrolizumab works better in treating patients with non-squamous non-small cell cancer.
Lung, Non Small Cell
III
York, Sally
NCT03793179
ECOGTHOEA5163

Testing the Ability to Decrease Chemotherapy in Patients with HER2-Positive Breast Cancer Who Have No Remaining Cancer at Surgery after Limited Pre-operative Chemotherapy and HER2-Targeted Therapy

Breast

This clinical trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, 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. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the bodys immune system. Pertuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
Breast
II
Abramson, Vandana
NCT04266249
ECOGBREEA1181

Immunotherapy (Nivolumab or Brentuximab Vedotin) Plus Combination Chemotherapy in Treating Patients with Newly Diagnosed Stage III-IV Classic Hodgkin Lymphoma

Multiple Cancer Types

This phase III trial compares immunotherapy drugs (nivolumab or brentuximab vedotin) when given with combination chemotherapy in treating patients with newly diagnosed stage III or IV classic Hodgkin lymphoma. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as doxorubicin, vinblastine, and dacarbazine, 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. The addition of nivolumab or brentuximab vedotin to combination chemotherapy may shrink the cancer or extend the time without disease symptoms coming back.
Pediatric Lymphoma, Pediatrics
III
Friedman, Debra
NCT03907488
COGPEDS1826