Active clinical trials for "Glioblastoma"

This non-interventional study aims to investigate change over time in cognitive function, sleep quality, and activity in daily life as important determinants of QoL in a large cohort of GBM patients in Germany treated with TTFields in routine clinical care using low-threshold, electronic PRO and modern automated tracking data analyses. The gained results will allow even better understanding of TTFields therapy in daily life of GBM patients and consequently, better informing patients about what to expect when starting this therapy, increasing therapy compliance in the long-term.

This is a multi-center, double-blind, 2:1 randomized phase III trial to determine whether the addition of AV-GBM-1, a therapeutic, patient-specific dendritic cell vaccine, to standard therapy increases OS of patients with a recent diagnosis of primary GBM. The intent is to enroll approximately 726 patients for tumor collection to enroll 690 who are eligible for treatment at the time of randomization and who have granted consent for participation. Because of the lack of toxicity, there are no restrictions related to performance status or blood tests at the time of treatment. The key endpoint is OS from date of first injection after RT/TMZ; secondary endpoints are PFS from date of first injection, and OS and PFS from date of randomization prior to RT/TMZ. Date of PFS will be determined by the principal investigator at each site.

Tailored approaches targeting crucial oncogenes and pathways have shown successful results in a number of cancer types and offer exciting perspective in neuro-oncology. IDH (Isocitrate dehydrogenase) wild-type (IDHwt) glioblastoma (GBM) (10%) present a unique and homogenous energetic metabolism which is specifically dependent on the oxidative phosphorylation (OXPHOS) rather than on the aerobic glycolysis. OXPHOS+ IDHwt GBMs overexpress mitochondrial markers and can be specifically inhibited by mitochondrial inhibitors in vitro and in vivo. Metformin is an oral inhibitor of mitochondrial complex I and is a widely used drug in diabetic and non-diabetic patients, safe and well tolerated in association with radiotherapy and chemotherapy. Basing on drastic effect, the investigators have observed in vivo (reduction of >50% of tumor growth) and hypothesize that metformin could be specifically efficient to treat up-front patients affected by OXPHOS+ GBM, in association with the standard first-line treatment with radiotherapy and temozolomide (RT-TMZ). The investigators set up a dedicated molecular analysis including RNA assay and expression of OXPHOS markers for formalin-fixed paraffin-embedded tumors (FFPE), which allows to detect OXPHOS+ GBM at diagnosis. Here a phase II, open label, non-randomized multicenter trial including five French neurooncology centers (H. Foch-Suresnes, Pitié-Salpêtrière-Paris, Saint Louis-Paris, Lyon, Marseille) and one in Italy (Istituto Besta, Milan) is proposed. Newly diagnosed IDH wild-type GBM patients with the OXPHOS+ signature will be eligible for inclusion in this trial. The investigators expect to screen 640 patients and to include 64 patients over a period of 24 months with 24 months of follow-up.

The aim of the present study is the prospective controlled use of physical activity in a collective of patients with glioblastoma after surgery and concomitant radiation/chemotherapy and during adjuvant cytotoxic therapy. The research question is whether physical exercise is feasible and whether patients benefit physically and mentally from the activities performed. For this purpose, specific training units under the supervision of a certified trainer and sports scientist as well as standardized sports medical test procedures are implemented. Beyond the instructed training, general physical activity phases are recorded electronically using a pedometer/activity tracker, which is worn at all times. It will be examined whether the individual training program improves physical fitness increases quality of life/life satisfaction throughout the intervention can be detected in blood due to increased concentrations of brain-derived neurotrophic factor 1 (BDNF-1) (voluntary) The measurements should be taken before and 8, 16 and 24 weeks after the start of training.

The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.

MicroRNAs (miRNA) are molecular biomarkers that post-transcriptionally control target genes. Deregulated miRNA expression has been observed in diverse cancers. In high grade gliomas, known as glioblastomas, the investigators have identified an oncogenic miRNA, miRNA-10b (mir-10b) that is expressed at higher levels in glioblastomas than in normal brain tissue. This study tests the hypothesis that in primary glioma samples mir-10b expression patterns will serve as a prognostic and diagnostic marker. This study will also characterize the phenotypic and genotypic diversity of glioma subclasses. Furthermore, considering the critical function of anti-mir-10b in blocking established glioblastoma growth, the investigators will test in vitro the sensitivity of individual primary tumors to anti-mir-10b treatment. Tumor, blood and cerebrospinal fluid samples will be obtained from patients diagnosed with gliomas over a period of two years. These samples will be examined for mir-10b expression levels. Patient survival, as well as tumor grade and genotypic variations will be correlated to mir-10b expression levels.

This is a first-in-human study of CM93, an oral investigational drug, in adults with Epidermal Growth Factor Receptor-modified glioblastoma. The study is designed in three parts consisting of a dose-escalation phase, a dose-expansion phase and a window-of-opportunity surgical trial. The trial objectives are to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical effects of CM93 in this patient population.

The purpose of this clinical trial is to evaluate the addition of NG101m adjuvant therapy to standard of care treatment of glioblastoma multiforme. All subjects will receive NG101m capsules along with the standard treatment of temozolomide and radiation.

This trial is a translational, open-label, multicentric, prospective cohort study of 900 patients aiming to describe the PD-1 (programmed death) expression in T cells (T lymphocytes) in different solid tumors. The study will be conducted on a population of patients with local and/or metastatic malignant solid tumor and who are followed within a standard of care procedure or clinical trial. Patients with any of the following tumor types may be enrolled in the trial: Head and neck cancer, Ovarian cancer, Cervical cancer, Pre-invasive CIN III cervical cancer (Cervical Intra-epithelial Neoplasia III cervical cancer), Other solid tumor types (including glioblastoma, NSCLC (Non-small cell lung cancer), anal cancer) Each tumor type will be considered as an independent cohort. For each included patient, biological specimen (tumor sample, blood samples and ascites samples if applicable) will be collected. Study participation of each patient will be 5 years.

This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.