Intra-arterial Chemotherapy for the Treatment of Progressive Diffuse Intrinsic Pontine Gliomas (DIPG)....
Diffuse Intrinsic Pontine Glioma (DIPG)The goal of this pilot study is to determine if intra-arterial (IA) chemotherapy is safe in the treatment of progressive diffuse intrinsic pontine gliomas (DIPG). IA administration of the chemotherapeutic agent enhances the regional distribution of the drug, thereby increasing the local delivered dose while minimizing systemic toxicity. It also provides a treatment option for these patients at the time of tumor recurrence.
Immune Modulatory DC Vaccine Against Brain Tumor
Diffuse Intrinsic Pontine Glioma or GlioblastomaThis study is designed to treat patients who have been diagnosed with brain cancer, including glioblastoma (GBM) and diffuse intrinsic pontine glioma (DIPG). The treatment uses immunomodulatory vaccine generated by autologous dendritic cells (DCs) pulsed with genetically modified tumor cells or tumor-related antigens including neoantigens to inject into patients. Vaccine-induced T cell responses have been associated with improved survival. The study will evaluate the safety and potential benefit of the novel immunomodulatory DC vaccines.
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor...
Diffuse Intrinsic Pontine GliomaThe purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication
Diffuse Intrinsic Pontine GliomaDiffuse Intrinsic Pontine Gliomas (DIPG) appear almost exclusively in children and adolescents, representing 15 to 20% of posterior fossa tumours. Even if it is one of the most common malignant brain tumours, there are only 30 to 40 new cases per year in France. Their clinical presentation is stereotyped with a short clinical history and a unique MRI appearance that was usually considered as sufficient to establish the diagnosis. The prognosis of DIPG is always unfavourable; median overall survival is 9 to 10 months in general and most patients will die within two years after diagnosis (Kaplan 1996,Hargrave 2006). Malignant gliomas infiltrating the brainstem represent the greatest challenge of paediatric oncology; despite numerous collaborative studies performed, patients' survival has not significantly increased in thirty years (Hargrave 2009). There is no validated prognostic factor. There is currently no validated treatment except radiotherapy. Several targeted agents have been tested in DIPG (Pollack 2007 Haas-Kogan 2008, Geoerger, 2011), without knowing whether the target was present in the tumour. A critical review of the paradigms of these trials tells us that there are long term survivors in these studies that is to say patients who may have benefited from the tested therapy, but they are few. So far, the new therapies that have been tried were evaluated one after the other in search of a treatment that would be effective for all patients, measuring the treatment effect on median survival. They were all rejected as ineffective. However the investigators can challenge the endpoint to evaluate efficacy in these trials as the existence of long term survivors (> 18 months, for example) and their number should not been ignored, especially if targeted therapies are considered. The investigators propose a paradigm shift in the choice of treatment; the issue raised would be to give to each patient the treatment associated with the highest likelihood of efficacy based on the specific biological tumour profile. The development of targeted therapies for malignant gliomas infiltrating the brainstem has been hampered by the absence of biological data. It is therefore crucial to better understand the biology of these tumours. Despite the safety of the biopsy in brainstem tumours, most teams of paediatric neurosurgery limit the use of stereotactic biopsy only for clinically or radiologically unusual forms. Until recently, there has been no systematic genetic study at diagnosis to date and the few available data were confounded by the inclusion of autopsies or clinically and radiologically unusual cases (Louis, 1993; Gilbertson 2003; Okada, 2008; Zarghooni 2010; Broniscer, 2010; Wu, 2012 and Schwartzentruber, 2012). French teams gathered in the French Society of Paediatric Oncology and the European consortium "Innovative Therapies in Children with Cancer (ITCC)" decided a few years ago to perform biopsies of these tumours for diagnostic confirmation and to ensure the presence of certain therapeutic targets prior to a possible inclusion in a trial evaluating a targeted therapy (Geoerger, 2009; Geoerger, 2010). Part of this experiment was reported by the team of the Necker Hospital in Paris, confirming the low rate of complications of stereotactic biopsy procedure (Roujeau, 2007). The biopsy specimen analysis allowed practicing immunohistochemical, genomic (CGHarray), gene expression (transcriptome) and direct sequencing of candidate genes studies. In this study, the majority of patients will receive a treatment assumed to specifically target a biological abnormality identified on the biopsy. More importantly, patients will not receive a drug for which the identified target is absent. In this first step of the protocol, the patients will thus be allocated to one of the three treatment groups as follows: If the tumor overexpresses EGFR without PTEN loss of expression, patients may receive erlotinib or dasatinib allocated by randomization (R1 randomisation). If the tumor shows loss of PTEN expression without EGFR overexpression, patients may receive everolimus or dasatinib allocated by randomisation (R2 randomisation). If the tumor shows both EGFR overexpression and loss of PTEN expression, patients may receive erlotinib, everolimus or dasatinib by randomisation (R3 randomisation). If the tumor shows neither EGFR overexpression nor loss of PTEN expression (a very rare situation in our experience), patients will receive dasatinib (no randomisation). If the biopsy assessment is not contributive, the treatment will be allocated by randomisation between erlotinib, everolimus and dasatinib (R3 randomisation).
Anti PD1 Antibody in Diffuse Intrinsic Pontine Glioma
DIPGDiffuse pontine gliomas are incurable with currently used treatments. based on data stating that progressive tumors inhibit immune system, would try to enhance immune system activity and tumor cell killing. anti PD1 prevents one of the important mechanisms allowing the tumor to supress the immune system thus we hope it will allow for prolonged control of the tumors
Exploratory Study of Effects of Radiation Therapy in Pediatric Patients With Central Nervous System...
Diffuse Intrinsic Pontine GliomaPNET3 moreThis study will analyze the effects of radiation given to children who have tumors of the central nervous system (CNS). Researchers want to learn more about changes in the quality of life that patients may experience as a result of radiation. Patients ages 21 and younger who have a primary CNS tumor and who have not received radiation previously may be eligible for this study. They will have a medical history and physical examination. Collection of blood (about 2-1/2 tablespoons) and urine will be done, as well as a pregnancy test. Patients will complete neuropsychological tests, which provide information about their changes in functioning over time. An expert in psychology will give a number of tests, and the patient's parents or guardian will be asked to complete a questionnaire about the patient's behavior. Also, patients will be given a quality of life questionnaire to complete and vision and hearing tests. The radiation itself is prescribed by patients' doctors and is not part of this study. Magnetic resonance imaging (MRI) will give researchers information about the tumor and brain, through several scanning sequences . MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. Patients will lie on a table that slides into the enclosed tunnel of the scanner. They will need to lie still, and medication may be given to help them to do that. They may be in the scanner for up to 2 hours. As the scanner takes pictures, patients will hear knocking or beeping sounds, and they will wear earplugs to reduce the noise. A contrast agent will be administered, to allow images be seen more clearly. Blood and urine tests will be conducted after the first dose of radiation. MRI scans will be done 2 weeks after patients finish radiation therapy and again at 6 to 8 weeks, 6 months, 12 months, and yearly. Also at those follow-up periods, patients will undergo similar procedures as previously, including blood and urine tests and neuropsychological testing. Patients can remain in this study for 5 years. ...
Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
Glial Tumor of BrainDiffuse Intrinsic Pontine Glioma1 moreThe primary aim of this study is to determine the presence of gemcitabine in childhood diffuse midline gliomas (DMG) (previously classified as diffuse intrinsic pontine glioma [DIPG]) after systemic treatment with the drug.
Expanded Access Use of ONC201 in a Patient With Diffuse Intrinsic Pontine Gliomas
GliomaThis is an intermediate-size expanded access protocol to provide ONC201 to patients with diffuse intrinsic pontine gliomas who cannot access ONC201 through clinical trials.
Expanded Access to OKN-007 for Patients With Diffuse Midline Glioma, H3 K27-altered
Diffuse Midline GliomaH3 K27M-Mutant1 moreTo provide OKN-007 for compassionate use in patients with diffuse midline glioma, H3 K27-altered (DMG), including diffuse intrinsic pontine glioma (DIPG), pediatric and young adult patients with high-grade diffuse midline glioma will be treated under this Intermediate-sized expanded access treatment protocol.