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Astrocytoma clinical trials

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NCT ID: NCT03657576 Recruiting - Clinical trials for Glioblastoma Multiforme of Brain

Trial of C134 in Patients With Recurrent GBM

C134-HSV-1
Start date: September 23, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this project is to obtain safety information in small groups of individuals, scheduled to receive escalating doses of C134, a cancer killing virus (HSV-1) that has been genetically engineered to safely replicate and kill glioma tumor cells. Safety will be assessed at each dose level before proceeding to the next dose level. A special statistical technique called the Continual Reassessment Method (CRM) will be used to determine when higher doses of virus can be administered. Other objectives of the study include characterization of the activity of C134 after inoculation into the tumor and of the local and systemic immune responses to C134. Patients will also be followed with MRI scans for potential clinical response to C134. The clinical strategy takes advantage of the virus' ability to infect and kill tumor cells while making new virus within the tumors cells; a critical enhancement of this effect is accomplished by the induction of an anti-tumor immune response; both effects are produced by the IRS-1 gene that was placed into the virus by genetic engineering. An additional important component of the research are systematic assessments of the quality of life on treated patients.

NCT ID: NCT03633552 Recruiting - Clinical trials for Glioblastoma Multiforme of Brain

Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma

Start date: March 3, 2018
Phase: Phase 3
Study type: Interventional

This is a phase III, non-blinded, blocked randomized clinical trial. The study is conducted on 62 newly diagnosed patients with brain glioblastoma multiforme and anaplastic astrocytoma referring to the oncology clinics during March 2018 and March 2019. The patients will be randomized to 6-cycle and 12-cycle adjuvant Temozolomide groups using block randomization method (1:1).

NCT ID: NCT03603405 Recruiting - Glioblastoma Clinical Trials

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Start date: February 28, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).

NCT ID: NCT03596086 Recruiting - Clinical trials for Glioblastoma Multiforme

HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

Start date: December 11, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.

NCT ID: NCT03370926 Recruiting - Clinical trials for Glioblastoma Multiforme

FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy

IMAGG
Start date: October 31, 2016
Phase: N/A
Study type: Observational

Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema. To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.

NCT ID: NCT03243461 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

International Cooperative Phase III Trial of the HIT-HGG Study Group (HIT-HGG-2013)

HIT-HGG-2013
Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

The HIT-HGG-2013 trial offers an innovative high-quality diagnostics and science program for children and adolescents >3 years, suffering from one of the following types of high grade gliomas: 1. glioblastoma WHO grade IV (GBM) 2. diffuse midlineglioma histone 3 K27M mutated WHO grade IV (DMG) 3. anaplastic astrocytoma WHO grade III (AA) 4. diffuse intrinsic pontine glioma (DIPG) 5. gliomatosis cerebri (GC) For 1.-3. diagnosis has to be confirmed by neuropathological survey, for 4. and 5. diagnosis has to be confirmed by neuroradiological survey. In addition to standard treatment (radiotherapy and temozolomide chemotherapy) the effect of valproic acid which is traditionally used for treatment of seizure disorder, will be investigated. The aim of the trial will be to investigate whether this drug may increase the effects of radio- and chemotherapy, resulting in a better survival of the treated patients. Scientific studies provided evidence for anti-tumoral effects of valproic acid: the drug seems to be a so-called histondeacetylase inhibitor (HDAC inhibitor), controlling important genetic processes of tumor growth. Studies in cell culture, animals and first clinical trials in adults as well provided evidence for efficacy of valproic acid in the treatment of glioblastoma. Due to this we hope children and adolescents suffering from GBM, DMG, AA, DIPG und GC will benefit from the treatment, too. The aim of the HIT-HGG-2013 trial will be to compare the effects of Valproic acid with data of the HIT-HGG-2007 trial (children and adolescents with same diseases, only treated with simultaneous temozolomide radiochemotherapy). In the present study, it was originally planned to investigate the therapeutic efficiency and safety of valproic acid and the autophagy inhibitor chloroquine, both in addition to temozolomide therapy. Since distribution of Resochin junior (chloroquine phosphate) was terminated, recruitment of new patients was stopped on August 8, 2019. For continuation of the trial, the chloroquine arm was closed but the patients already recruited in this arm will be followed up.

NCT ID: NCT03152318 Recruiting - Glioblastoma Clinical Trials

A Study of the Treatment of Recurrent Malignant Glioma With rQNestin34.5v.2

rQNestin
Start date: July 18, 2017
Phase: Phase 1
Study type: Interventional

This research study is evaluating an investigational drug, an oncolytic virus called rQNestin34.5v.2. This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to define the appropriate dose of the investigational drug as a possible treatment for this diagnosis of recurrent or progressive brain tumor.

NCT ID: NCT03115164 Recruiting - Astrocytoma Clinical Trials

Astrocytoma / Desmoplastic Gamliogliomes (DIA / DIG) - Study of the French Cohort of the Last 20 Years : Clinical, Anatomopathological, Molecular and Radiological Charactersics

DIA/DIG
Start date: August 18, 2016
Phase: N/A
Study type: Observational

Astrocytomas / infantile desmoplastic gangliogliomas (DIA / DIG) are rare brain tumors usually affecting infants. They represent about 0.5% of all pediatric brain tumors. DIA / DIG occurs mainly in the first 2 years of life, with a sex ratio M / F of 1.7 to 1. From a histological point of view, DIA / DIG are neuroepithelial tumors. These tumors may have a purely astrocytic differentiation (DIA) or be composed of tumor cells with astrocytic and neuronal differentiation (DIG). The desmoplastic component is usually adjacent to the meninges and is defined by the increase or modification of connective tissues related to the presence of neoplastic cells with the formation of a collagen-rich extracellular matrix. Due to their benign biological behavior and favorable clinical course, they are classified in benign tumors, ie grade I according to the WHO classification. However, all tumors called DIA / DIG do not behave in a benign manner. Cases of metastatic cerebrospinal and malignant disorders have been described. It appears that about 40% of DIG cases require additional medical treatment such as chemotherapy, radiotherapy and / or new surgery, and 15% of infants and children with GIDD die from the disease. It is possible that what is grouped within the DIA / DIG is a heterogeneous group of tumors, evolution and prognosis very variable. The cytogenetic knowledge of DIA / DIG is very limited and is only available on small numbers of cases. Cytogenetic analyzes of several cases of DIG showed normal karyotypes. More recently, a CGH-Array study of 3 cases of DIA / DIG did not find any significant chromosomal gains or losses. It has been shown, however, that a mutation involving BRAF (BRAF rearrangement or BRAF V600E mutations) was a recurrent element in low grade gliomas, particularly in pediatric patients. It is also suggested that deregulation of BRAF activity in some DIA / DIG may indicate the importance of the MAPK (mitogen-activated protein kinase) pathway in signaling pathways for DIA / DIG development. However, data on the link between the BRAF gene and DIA / DIG remains very limited. Thus, further studies are needed to study the other members of the MAPK pathway in DIA / DIG (eg PI3K / AKT / mTOR). This could provide new therapeutic possibilities involving targeted therapies specific to the MAPK signaling pathway. It appears that DIA / DIG does not all behave in a benign manner and some would undergo a malignant transformation that could be due to chromosomal alterations such as, for example, TP53, PI3K. In addition, because of the limited number of cases, it would be interesting to study the characteristics of patients with DIA / DIG in order to study their characteristics and whether there are clinical, pathological, cytogenetic and / Molecular forms between benign and malignant forms.

NCT ID: NCT02800486 Recruiting - Glioblastoma Clinical Trials

Super Selective Intra-arterial Repeated Infusion of Cetuximab (Erbitux) With Reirradiation for Treatment of Relapsed/Refractory GBM, AA, and AOA

Start date: May 2016
Phase: Phase 2
Study type: Interventional

Primary brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. GBM often has a high expression of EFGR (Epidermal Growth Factor Receptor), which is associated with poor prognosis. Several methods of inhibiting this receptor have been tested, including monoclonal antibodies, vaccines, and tyrosine kinase inhibitors. The investigators hypothesize that in patients with recurring GBM, intracranial superselective intra-arterial infusion of Cetuximab (CTX), at a dose of 250mg/m2 in conjunction with hypofractionated radiation, will be safe and efficacious and prevent tumor progression in patients with recurrent, residual GBM.

NCT ID: NCT02766699 Recruiting - Glioblastoma Clinical Trials

A Study to Evaluate the Safety, Tolerability and Immunogenicity of EGFR(V)-EDV-Dox in Subjects With Recurrent Glioblastoma Multiforme (GBM)

CerebralEDV
Start date: October 25, 2016
Phase: Phase 1
Study type: Interventional

The purpose of the Cerebral EDV study is to determine the safety and tolerability of EGFR(V)-EDV-Dox in order to establish the best dose level to be used in future studies. The study will also examine the body's immune response to EGFR(V)-EDV-Dox and assess if it is effective in the treatment of patients with recurrent glioblastoma multiforme (GBM).