Brief Summary
This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.
Protocol Interventions
Drug: Dabrafenib, Drug: Trametinib, Procedure: Magnetic Resonance Imaging (MRI), Procedure: Specimen Collection, Procedure: Optional Lumbar puncture
Brief Summary
This is an open-label, comprehensive, iterative investigation of evaluating the use of induction chemotherapy, high-dose chemotherapy, and focal radiation therapy in children with newly diagnosed Embryonal Tumor With Multilayered Rosettes (ETMR).
Protocol Interventions
Radiation: Radiotherapy (RT), Drug: Chemotherapy Drug, Cancer – Physician’s Choice, Procedure: Non-Investigational Surgical Resection, Drug: Temozolomide, Procedure: Tumor Tissue Sample, Procedure: Blood Sample, Procedure: Cerebrospinal Fluid (CSF) Sample
Brief Summary
This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to repair deoxyribonucleic acid damage caused by cancer treatments, such as radiation therapy. This may help overcome resistance to therapy seen in these cancers and therefore lead to increased death of cancer cells. Radiation therapy uses high energy x-rays or particles to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.
Protocol Interventions
Drug: ATM Kinase Inhibitor AZD1390, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Radiation: Radiation Therapy, Other: Survey Administration
Brief Summary
The purpose of this study is to evaluate the efficacy of digoxin in treating relapsed non-SHH, non-WNT medulloblastoma in pediatric and young adult patients.
Protocol Interventions
Drug: Digoxin
Brief Summary
This phase II trial studies how well lower dose radiotherapy after chemotherapy (Carboplatin & Etoposide) works in treating children with central nervous system (CNS) germinomas. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Researchers want to see if lowering the dose of standard radiotherapy (RT) after chemotherapy can help get rid of CNS germinomas with fewer long-term side effects.
Protocol Interventions
Radiation: 3-Dimensional Conformal Proton Radiation Therapy, Radiation: 3-Dimensional Conformal Radiation Therapy, Procedure: Biospecimen Collection, Drug: Carboplatin, Drug: Etoposide, Procedure: Intensity-Modulated Proton Therapy, Radiation: Intensity-Modulated Radiation Therapy, Procedure: Lumbar Puncture, Procedure: Magnetic Resonance Imaging, Other: Questionnaire Administration
Brief Summary
This is a multisite, phase I/II clinical trial in children and young adults with newly-diagnosed high-grade glioma (HGG), diffuse midline glioma (DMG) and recurrent HGG/DMG, Medulloblastoma (MB), or ependymoma (EPN) to determine the safety, immunogenicity, and efficacy of a CMV-directed peptide vaccine plus checkpoint blockade.
Protocol Interventions
Biological: PEP-CMV vaccine, Biological: Tetanus booster, Biological: Nivolumab, Drug: Temozolomide
Brief Summary
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB).
PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51.
Funding Source – FDA OOPD
Protocol Interventions
Biological: PEP-CMV, Drug: Temozolomide, Biological: Tetanus Diphtheria Vaccine
Brief Summary
This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive). Natural killer (NK) cells are immune cells that recognize and get rid of abnormal cells in the body, including tumor cells and cells infected by viruses. NK cells have been shown to kill different types of cancer, including brain tumors in laboratory settings. Giving NK cells from unrelated donors who are screened for optimal cell qualities and determined to be safe and healthy may be effective in treating supratentorial malignant brain tumors in children and young adults.
Protocol Interventions
Biological: Universal Donor (UD) Transforming growth factor beta imprinting (TGFβi) Natural Killer (NK) Cells, Procedure: Implantation, Procedure: Magnetic Resonance Imaging (MRI), Other: Quality-of-Life Assessment