View clinical trials related to Glioblastoma.
Filter by:The objectives of the trial are: To assess safety, tolerability and activity of nelfinavir given neo-adjuvant and concomitant to chemoradiotherapy with temozolomide in patients with a newly diagnosed glioblastoma multiforme. To describe the possible effect of nelfinavir on functional imaging To describe the activity of nelfinavir in vivo on blocking the AKT pathway.
The purpose of this research study is to learn if your own immune cells can be activated and multiplied in order to help your body fight off the tumor cells in your brain. The safety of this procedure will also be studied. This procedure, called CMV-autologous lymphocyte transfer or CMV-ALT is investigational which means that it is not approved by the US Food and Drug Administration (FDA) and is still being tested in research studies. Autologous lymphocyte transfer or ALT means that you will receive your own immune cells back (and not from another donor) as a treatment after they have been activated and grown to large numbers in a clinical lab. It is believed that the body's immune (protection) system can attack tumor cells and kill them. Immune cells called T-lymphocytes (T-cells) can recognize special proteins on the surface of tumors as a signal to attack and fight the cancer. In most patients with advanced cancer, the immune system does not adequately destroy the tumor because the white blood cells or T-cells are not stimulated enough. Before your T-cells can become active against tumor cells, they require strong stimulation. There are special "stimulator" cells in the body called Dendritic Cells (DCs) that can take up proteins released from cancer cells and present pieces of these proteins to T lymphocytes to create this strong stimulation. Dendritic cells taken from your blood will be "pulsed" or loaded with genetic material called RNA (ribonucleic acid), which stimulates the DC to change the RNA into a protein called pp65. This protein is produced by a common virus called Cytomegalovirus (CMV) that 70-80% of us have been exposed to in our lifetime. Recently, we have found that this virus is present in many malignant brain tumors. Brain tumors are very aggressive and, for reasons we do not yet understand, are difficult for the body to attack. The CMV virus is a target in the tumor that, if attacked by your immune systems cells, may prevent your tumor from growing. We have found that we can grow immune cells to very large numbers from the blood of people who have evidence of prior exposure to this virus. You will therefore be tested to determine if you have pre-existing antibodies to this virus in order to participate in this study. We will use your DCs to activate and grow immune cells from your blood to large numbers in a clinical laboratory. These CMV-specific immune cells, called CMV-ALT, will be returned to your body when they have become activated. It is hoped that these cells will seek out and kill tumor cells that express the CMV viral protein and not attack normal cells. The transfer of immune cells that stimulates your immune system is called adoptive immunotherapy. We will evaluate two doses of immune cells in this study (Dose 1 and Dose 2). Depending on when you are enrolled in this study you will receive either Dose 1 or 2. The first six patients enrolled on this study will receive Dose 1 (the lower dose) and the next six patients will receive Dose 2 (the higher dose). We do not know at this time if either dose is more effective or safer to administer which is why we are testing both doses. Dose 2 will be a larger number of immune cells if the treatment is found to be safe in the first six patients treated during this study. In this study we will also see, in some randomly selected patients, if giving an injection of the DC pulsed with pp65 RNA into the skin improves the function of the CMV-ALT treatment or not. You will receive three injections under the skin of either some of the same DC that were used to stimulate your immune cells in the clinical laboratory or three injections of saline (salt solution) under the skin starting with the infusion of the CMV-ALT. It is unknown if a DC injection will be beneficial to the immune cells or not so the responses will be compared in patients who receive DC versus saline injection with their CMV-ALT. After these three injections, blood will be collected to compare the responses between patients that received saline to those that received DC injections.
CENTRIC is a Phase 3 clinical trial assessing efficacy and safety of the investigational integrin inhibitor, cilengitide, in combination with standard treatment versus standard treatment alone in newly diagnosed glioblastoma subjects with a methylated O6-methylguanine-deoxyribonucleic acid methyltransferase (MGMT) gene promoter in the tumor tissue. The MGMT gene promoter is a section of deoxyribonucleic acid (DNA) that acts as a controlling element in the expression of MGMT. Methylation of the MGMT gene promoter has been found to be a predictive marker for benefit from temozolomide (TMZ) treatment.
The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201 with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly diagnosed GBM and assess overall survival as the primary outcome measure. Information on each phase of the study will be listed when each phase opens for enrollment. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
The primary purpose of the study is to evaluate the efficacy and safety of early postsurgery temozolomide chemotherapy followed by the standard temozolomide regimen, compared to the standard regimen alone, for the treatment of patients with newly diagnosed glioblastoma multiforme.
The purpose of this study is to establish a Brain and Spinal Tumor Tissue/Specimen repository to serve as a resource for current and future scientific studies.
The purpose of this study is to evaluate the safety of combination therapy of radiotherapy and temozolomide ("concomitant radiotherapy phase"), and then temozolomide monotherapy ("monotherapy phase"), in patients with newly diagnosed glioblastoma multiforme. Progression free survival and response rate will also be calculated.
The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.
This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.
Cotara® is an experimental new treatment that links a radioactive isotope (iodine 131) to a targeted monoclonal antibody. This monoclonal antibody is designed to bind tumor cells and deliver radiation directly to the center of the tumor mass while minimizing effects on normal tissues. Cotara® thus literally destroys the tumor "from the inside out". This may be an effective treatment for glioblastoma multiforme, a malignant type of brain cancer.