Clinical Trials to Treat Adult Glioblastoma
Currently there are 11 trials by NCI for this aggressive disease. Cancer Research and Life foundation has proposed a trial with the agency that aims to treat patients with refractory glioblastoma who have failed other methods of care. In contrast with below list of trials, foundation believes that the technology it is pursuing could be superior in many levels. One foremost superiority is the non toxic nature of the technology. All below trials have moderate to severe list of toxicities from inflammatory disease to death. MTET sponsored by the foundation is currently approved for Glioblastoma as an orphan indication and further has shown extensive safety in both human and animal models, making it a potentially attractive method of treating Glioblastoma specially when other therapies fail.
We look forward to treat patients with advanced brain cancer through phase II/III clinical trials with such superior technology.
Dose-Escalated Photon IMRT or Proton Beam Radiation Therapy versus Standard-Dose Radiation Therapy and Temozolomide in Treating Patients with Newly Diagnosed Glioblastoma
This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT or proton beam radiation therapy is more effective than standard-dose radiation therapy with temozolomide in treating glioblastoma.
Location: 158 locations
Terameprocol in Treating Patients with Recurrent High-Grade Glioma
This phase I trial studies the side effects and best dose of terameprocol in treating patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as terameprocol, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Location: 8 locations
Adavosertib, Radiation Therapy, and Temozolomide in Treating Patients with Newly Diagnosed or Recurrent Glioblastoma
This phase I trial studies the side effects and best dose of adavosertib when given together with radiation therapy and temozolomide in treating patients with newly diagnosed or glioblastoma that has come back. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving adavosertib, radiation therapy, and temozolomide may work better in treating patients with newly diagnosed or recurrent glioblastoma.
Location: 11 locations
Study of the IDO Pathway Inhibitor, Indoximod, and Temozolomide for Pediatric Patients With Progressive Primary Malignant Brain Tumors
This is a first-in-children phase 1 trial using indoximod, an inhibitor of the immune “checkpoint” pathway indoleamine 2,3-dioxygenase (IDO), in combination with temozolomide-based therapy to treat pediatric brain tumors. Using a preclinical glioblastoma model, it was recently shown that adding IDO-blocking drugs to temozolomide plus radiation significantly enhanced survival by driving a vigorous, tumordirected inflammatory response. This data provided the rationale for the companion adult phase 1 trial using indoximod (IND#120813) plus temozolomide to treat adults with glioblastoma, which is currently open (NCT02052648). The goal of this pediatric study is to bring IDO-based immunotherapy into the clinic for children with brain tumors. This study will provide a foundation for future pediatric trials testing indoximod combined with radiation and temozolomide in the up-front setting for patients with newly diagnosed central nervous system tumors.
Location: 2 locations
Temozolomide and Targeted or Standard Brain Radiation Therapy in Treating Patients with Newly Diagnosed Glioblastoma Multiforme
This randomized phase II trial studies how well an increased dose of radiation therapy applied to a specific part of the brain works compared to standard radiation therapy when given with temozolomide in treating patients with a newly diagnosed brain tumor, such as glioblastoma multiforme. The brain contains cells called neural progenitor cells (NPC) that may be important in the brain’s response to injury but may also contribute to tumor recurrence. Subventricular zone radiation therapy targeting these cells may improve the local control and delay the brain tumor from coming back. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether subventricular zone radiation therapy and temozolomide are more effective than standard radiation therapy and temozolomide in treating patients with glioblastoma multiforme.
Location: Johns Hopkins University / Sidney Kimmel Cancer Center, Baltimore, Maryland
Low-Dose Whole-Brain Radiation Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
This phase II trial studies the side effects and how well low-dose whole-brain radiation therapy and temozolomide work in treating patients with newly diagnosed glioblastoma multiforme. Radiation therapy uses high-energy x-rays to kill tumor cells. Low-dose whole-brain radiation therapy may kill the microscopic tumor cells which are outside of the area of the brain that receives partial brain radiation therapy. Drugs used in chemotherapy, such as temozolomide, work to stop the growth of tumor cells by killing the cells. Giving low-dose whole-brain radiation therapy with temozolomide may kill more tumor cells.
Location: University of Maryland / Greenebaum Cancer Center, Baltimore, Maryland
Mibefradil Dihydrochloride and Hypofractionated Radiation Therapy in Treating Patients with Progressive or Recurrent Glioblastoma Multiforme
This phase I trial studies the side effects and best dose of mibefradil dihydrochloride when given together with hypofractionated radiation therapy in treating patients with glioblastoma multiforme that is growing, spreading, or getting worse (progressive), or has come back (recurrent). Mibefradil dihydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Mibefradil dihydrochloride may also make tumor cells more sensitive to radiation therapy. Hypofractionated radiation therapy is a radiation treatment in which the total dose of radiation is divided into large doses over a shorter period of time. Giving mibefradil dihydrochloride with hypofractionated radiation therapy may be a better treatment for patients with glioblastoma multiforme.
Location: Yale University, New Haven, Connecticut
Clinical Trial of IV OKN-007 in a Pilot Cohort of Human Recurrent Malignant Glioma Patients
This is an open label Phase 1b clinical trial of IV administration of OKN-007 in a pilot cohort of human recurrent malignant glioma patients. All patients will have been previously treated with the standard-of-care treatment which includes surgical resection, radiation and chemotherapy, and in some cases treatment for recurrent disease with investigational agents or bevacizumab (Avastin). Patients with unequivocal recurrence (first or greater) established by MRI with and without contrast (e.g., Gd-DTPA (Gadolinium-diethylene triamine pentacetic acid) and meeting inclusion and exclusion criteria, will be eligible for OKN-007 treatment on this protocol.
Location: See Clinical Trials.gov
AQ4N in Combination With Radiotherapy and Temozolomide in Subjects With Newly Diagnosed Glioblastoma Multiforme
Phase 1b of the study, will evaluate the safety and tolerability of AQ4N treatment at three different dose levels. Phase 2a of the study, will further evaluate the safety, tolerability, and in addition efficacy of AQ4N treatment at a tolerated dose selected from Phase 1b.
Location: See Clinical Trials.gov
EGFRBi-Armed Autologous T Cells in Treating Patients with Recurrent or Refractory Glioblastoma
This phase I / II trial studies the side effects and best dose of epidermal growth factor receptor bispecific antibody (EGFRBi)-armed autologous T cells and how well it works in treating patients with glioblastoma that have come back or does not respond to treatment. EGFRBi-armed autologous T cells coated with antibodies (proteins used by the immune system to target and kill foreign objects such as cancer cells) may have great ability to seek out, attach to, and destroy glioblastoma cells.
Location: Wayne State University / Karmanos Cancer Institute, Detroit, Michigan
Nelfinavir Mesylate, Radiation Therapy, and Temozolomide in Treating Patients With Glioblastoma Multiforme
This phase I trial is studying the side effects and best dose of nelfinavir mesylate (NFV) when given together with radiation therapy and temozolomide in treating patients with glioblastoma multiforme. Nelfinavir mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving nelfinavir mesylate together with radiation therapy and temozolomide may kill more tumor cells.
Location: University of Pennsylvania / Abramson Cancer Center, Philadelphia, Pennsylvania
https://www.cancer.gov/about-cancer/treatment/clinical-trials/adult-glioblastoma