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GBM clinical trials

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NCT ID: NCT02861898 Recruiting - Glioblastoma Clinical Trials

Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma

Start date: June 2016
Phase: Phase 1/Phase 2
Study type: Interventional

Primary brain cancer kills up to 10,000 Americans a year. These 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 EFGR (Epidermal Growth Factor Receptor) which is blocked by Cetuximab (CTX). The investigators have recently completed a separate Phase I clinical trial using superselective intra-arterial cerebral infusion (SIACI) of CTX after blood brain barrier disruption (BBBD) for recurrent GBM (Chakraborty et al, in revision, Journal of Neurooncology). The investigators found that intra-arterial infusion of CTX is well tolerated with few adverse effects. The investigators hypothesize that in patients with newly diagnosed GBM, repeated SIACI of this drug after BBBD will be safe and efficacious for our patients when combined with standard chemoradiation (STUPP protocol). This trial will be a non-randomized open label Phase I/II clinical trial. In addition to standard chemotherapy and radiation therapy (STUPP protocol) the patient will be given CTX intra-arterially after BBBD for a total of three doses at approximately post surgery days 30, 120 and 210.

NCT ID: NCT02717962 Active, not recruiting - Glioblastoma Clinical Trials

Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent Setting

Start date: January 20, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2, two arm, biomarker-driven study is to determine if treatment of O-6-methylguanine-DNA methyltransferase (MGMT) unmethylated glioblastoma with VAL-083 improves overall survival (OS), compared to historical control, in the adjuvant or recurrent setting.

NCT ID: NCT02663271 Terminated - Glioblastoma Clinical Trials

TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma

Start date: December 19, 2016
Phase: Phase 2
Study type: Interventional

Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Novocure has shown that when properly tuned, very low intensity, intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM Therapy) is a portable battery operated device, which produces TTFields within the human body by means of surface transducer arrays. The TTFields are applied to the patient by means of surface transducer arrays that are electrically insulated, so that resistively coupled electric currents are not delivered to the patient. Optune is currently FDA-approved as a single modality treatment for recurrent GBM when both surgical and radiotherapy options have been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM. This research study is being performed to determine whether or not TTFields combined with pulsed bevacizumab treatment increases overall survival in patients with bevacizumab-refractory GBM compared to historical controls treated with continuous bevacizumab alone or in combination with other chemotherapy.

NCT ID: NCT02623231 Not yet recruiting - Depression Clinical Trials

The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients

Cipralex&GBM
Start date: December 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Testing the effect of providing an antidepressant and anxiety-type escitalopram for patients with glioblastoma on patient's quality of life including the effect of treatment on mood and cognition during treatment.Two subgroups will fill questionnaires : - Questionnaire mini mental state exam (mmse) which is the maximum score of 30. A score of below 24 indicates a flaw in the level of dementia - Questionnaire depression / mood PHQ9P(Pa t i e n t H e a l t h Qu e s t i o n n a i r e - 9) - The M. D. Anderson Symptom Inventory (MDASI) - Evaluation of the hospital situation awareness (clinical assessment and questionnaire) - Cognitive assessment which will be carried out by the Department neuropsychological and include: - Executive function (Stroop) - Abstract Reasoning (similarities) - -Auditory and Spatial Attention (Digit span, Spatial span) visual memory and remembering Literature - Memory function - visual and auditory (ROCF, RAVLT) - Language function: Naming and verbal fluency - Mindstreems Neurotrax

NCT ID: NCT02465268 Completed - Glioblastoma Clinical Trials

Vaccine Therapy for the Treatment of Newly Diagnosed Glioblastoma Multiforme

ATTAC-II
Start date: August 9, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine if an investigational dendritic cell vaccine, called pp65 DC, is effective for the treatment of a specific type of brain tumor called glioblastoma (GBM) when given with stronger doses of routine chemotherapy.

NCT ID: NCT02207010 Completed - Glioblastoma Clinical Trials

A Phase 0 Study of AZD1775 in Recurrent GBM Patients

Start date: July 2014
Phase: Early Phase 1
Study type: Interventional

This study would test how much of the new drug, AZD1775, is present in tumor, blood, and skin after one dose of the drug. The purpose of the study is not to treat the tumor, but to see if the drug actually gets into the tumor cells. This study does not replace routine cancer treatment.

NCT ID: NCT02146066 Available - Clinical trials for Glioblastoma Multiforme

Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221

DCVax-L EAP
Start date: n/a
Phase: N/A
Study type: Expanded Access

The study is an open-label expanded access study for patients for whom vaccine was manufactured during the Northwest Biotherapeutics' 020221 DCVax-L for GBM screening process, but who subsequently failed to meet specific enrollment criteria. Patients will receive therapy per investigator discretion (standard of care) as well as active vaccine per the 020221 protocol administration schedule. It is estimated that approximately 99 patients will enroll in this study.

NCT ID: NCT01856933 Completed - Clinical trials for Glioblastoma Multiforme

BrUOG 263: Prostate Specific Membrane Antigen (PSMA) Glioblastoma Multiforme (GBM)

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of Prostate Specific Membrane Antigen (PSMA ADC), as well as its safety and side effects for patients with advanced brain tumors. This study will also study how your body metabolizes (breaks down) PSMA ADC.

NCT ID: NCT01756352 Completed - Clinical trials for Glioblastoma Multiforme

FET-PET for Evaluation of Response of Recurrent GBM to Avastin

Start date: February 2013
Phase: Phase 2
Study type: Interventional

Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). We have defined one primary specific aim, for which we expect to obtain definitive results, and two secondary aims, under which we plan to generate preliminary data to support a future, larger project.

NCT ID: NCT01752491 Active, not recruiting - Glioblastoma Clinical Trials

A Phase I Trial of High-Dose Ascorbate in Glioblastoma Multiforme

Start date: April 1, 2013
Phase: Phase 1
Study type: Interventional

This is a phase 1 (first in man) study testing the safety of adding high dose ascorbate (vitamin C) to standard radiation and chemotherapy for initial treatment of glioblastoma multiforme (GBM).