Active clinical trials for "Glioma"

Background : In malignant gliomas, hypoxia is associated with tumour angiogenesis and tumour progression. This multidisciplinary preclinical and clinical project aims to validate the use of 18F-FMISO as a hypoxic marker for diagnosis, treatment and follow-up of malignant gliomas. Indeed, non-invasive methods of imagery such as Positron Emission Tomography (PET) and biological methods (after surgical resection) to detect the endogenous expression of factors induced by the hypoxia would allow to identify hypoxic areas. Identifying, with accuracy, the hypoxic areas could allow the clinicians to evaluate the response to the anti-angiogenic agents (preliminary validation in the preclinical project) and to optimize the combination of the anti-VEGF treatments with other conventional therapeutic approaches (radiotherapy, chemotherapy or other molecules). Research project : This research project includes 3 steps : first the investigators will establish the 18F-FMISO production technique for clinical application at CYCERON PET center. The second step consists in the preclinical validation of 18F-FMISO as a hypoxic marker and as a powerful tool for evaluating the therapeutical efficiency of anti-angiogenic treatment (sutent) in experimental rat gliomas. The third step is the clinical trial HypOnco. This research proposal aims to develop and use non invasive imaging methods (18F-FMISO with PET) and biological methods (after surgical resection) to detect hypoxic (HIF1 and HIF2) and angiogenic (VEGF and EPO) regions in different malignant gliomas with different degrees of vascularization (15 patients with grade III gliomas and 15 patients with grade IV glioblastomas). Within the same patient 18F-FMISO as a hypoxic index will be performed. A magnetic resonance imaging examination (MRI) including perfusion sequences and MR spectroscopy will also be assessed for each patient. Following this imaging protocol, surgical resection will be performed allowing us to study expression of endogenous factors induced by hypoxia and angiogenic factors by real time RT-PCR and in immunohistochemistry. The data obtained will enable us to establish : a hypoxic index (18F-FMISO with PET). an index of hypoxic factor expression (HIFs) an angiogenic index (VEGF, EPO, vascular markers) The investigators will characterize the links between these data and also with the following parameters: clinical (age, Karnofsky performance status, survival) MR parameters included perfusion and spectroscopy histological (necrosis, cellular proliferation, atypical cell abnormalities, vascularization). Expected results and clinical advantages To establish the 18F-FMISO production technique To propose the 18F-FMISO as a non-invasive marker for efficacy of antiangiogenic treatment in a preclinical study. To define the relationship between the 18F-FMISO uptake and tumour grade, patient survival, tumour recurrence, expression of hypoxic and angiogenic factors and tumour vascularisation. To provide a hypoxic index in cerebral tumours from 18F-FMISO PET, allowing diagnosis and prognosis improvement for optimal treatment orientation and strategy. In the field of the clinical applications, this tool will allow to : Optimize radiotherapy treatment by identifying with accuracy, using 18F-FMISO PET, the most hypoxic areas which are also the most radio resistant. Evaluate antiangiogenic therapy efficacy

Primary Objectives To compare progression free survival (PFS), the time from randomization to progressive disease,in children with optic pathway glioma (OPG) age ≥ 6 months to < 18 years, who receive combination antineoplaston therapy (ANP therapy) vs. temozolomide (TMZ); study subjects will have 1) received prior treatment with carboplatin or cisplatin, which was terminated secondary to toxicity or progression of OPG, or 2) developed recurrence of OPG after completion of carboplatin or cisplatin therapy. PFS data will be censored on the date of the last tumor assessment documenting absence of progression for study subjects: Who are alive, on study and are progression-free at the time of the analysis; Who discontinue, receive no subsequent therapy and are progression-free at the time of the analysis; Who are given/change therapy other than the study treatment prior to observing progression; Who discontinued (due to personal preference or toxicity) with a change in therapy, withdrew, or was lost to follow-up; For whom documentation of disease progression or death occurs after ≥ 2 consecutive missed tumor assessments. To describe the toxicity profile for ANP therapy vs. TMZ. Secondary Objectives: To compare overall survival (OS) for subjects treated with ANP therapy vs. TMZ; To compare disease stabilization rates for subjects treated with ANP therapy vs. TMZ; To compare complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) rates for subjects treated with ANP therapy vs. TMZ.

This clinical trial studies magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade glioma.

Major advances in cancer genetics over the past decade have revealed that the genes encoding IDHs are frequently mutated in a variety of human malignancies, including gliomas.Pentavalent 99mTc dimercaptosuccinic acid (99mTc (V) DMSA), is a nonspecific tumor targeting SPECT radiotracer, that has been used for imaging of various tumors including lung and breast carcinoma. However, to date, scarce reports discussed the utility of DMSA-V in patients with glioma.SPECT has the advantages of being widely available and not expensive. Multiple SPECT tracers have been explored. Of them Thallium-201 and 99 mTc-MIBI are, possibly, the most extensively discussed.

The aim of this study is to evaluate the correlation between degree of 99mTc-DMSA (V) uptake at SPECT/CT and IDH mutation in patients with brain glioma.

Participation in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This trial will admit a wide range of data on the clinical trial experience of glioma patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future glioma patients.

The overall goal of this study is to determine if quantitative imaging techniques can be used to detect dynamic changes of morphology and different physiologic properties of the tumor during and after completion of radiation treatment and to predict site and time of radiation.

To retrospectively explore the feasibility of multi-dimensional heterogeneity imaging features of MRI in predicting the status of key gene mutations in high-grade gliomas; To prospectively explore the correlation between multi-dimensional heterogeneous MRI image features and prognosis of high-grade glioma patients.

To evaluate 18F-FDOPA PET obtained from PET/CT or PET/MRI imaging in patients with newly diagnosed or recurrent gliomas.