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Last page update: September 24, 2017

This page has been divided into two major sections – newly diagnosed and recurrent/progressive. The trials for recurrences are found on the bottom half of the page. Additional trials for glioblastoma also found on Currently Recruiting Trials – High Grade Glioma

New Trials (added here in the last month)

Added September 24, 2017
An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma. Phase 2, single group, open-label. San Francisco CA, Santa Monica CA, Boca Raton FL, New York NY, Durham NC, Cleveland OH, Columbus OH, Dallas TX, San Antonio TX. Estimated primary completion date November 2018.
NCT02858895

Added September 24, 2017
A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma. Single group, open label. Lille France. Estimated primary completion date: December 2019.
NCT03048240

Newly diagnosed

Vaccines and Cell therapies – Newly diagnosed

A Randomized, Double Blind Phase II Trial of Radiation Therapy Plus Temozolomide and Pembrolizumab With and Without HSPPC-96 in Newly Diagnosed Glioblastoma (GBM). NIH Bethesda Maryland. Estimated primary completion date: May 2018.
NCT03018288

Randomized, double-blinded
Evaluation of Overcoming Limited Migration and Enhancing Cytomegalovirus-specific Dendritic Cell Vaccines With Adjuvant Tetanus Pre-conditioning in Patients With Newly-diagnosed Glioblastoma. Duke University. Estimated primary completion date: March 2019. Randomized phase 2 trial. In addition to receiving CMV-specific dendritic cell vaccinations patients will be randomized to receive pre-conditioning with either tetanus/diptheria toxoid or autologous unpulsed dendritic cells in saline. A third, unblinded group will undergo basiliximab infusions and tetanus/diptheria preconditioning in addition to the CMV-specific dendritic cell vaccine.
NCT02366728

Placebo-controlled
A Phase II Randomized, Blinded, and Placebo-controlled Trial of CMV RNA-Pulsed Dendritic Cells With Tetanus-Diphtheria Toxoid Vaccine in Patients With Newly-Diagnosed Glioblastoma (ATTAC-II) . University of Florida, Gainesville. Estimated primary completion date: June 2023.
NCT02465268

Peptide Targets for Glioblastoma Against Novel Cytomegalovirus Antigens (PERFORMANCE). Phase 1. Duke University. Estimated primary completion date: March 2018.
NCT02864368

A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients. MD Anderson – Houston TX. Estimated primary completion date: June 2020.
For newly diagnosed GBM post-radiotherapy and temozolomide, and for recurrent GBM.
NCT02661282

Placebo-controlled
A Phase 3 Randomized Double-blind, Controlled Study of ICT-107 With Maintenance Temozolomide (TMZ) in Newly Diagnosed Glioblastoma Following Resection and Concomitant TMZ Chemoradiotherapy. Recruiting in California (3 locations), Connecticut (2 locations), Atlanta GA, Kentucky (2 locations), Minneapolis MN, New Jersey (2 locations), New York (4 locations), Ohio (2 locations), Oklahoma City OK, Pennsylvania (2 locations), Portland OR, Charleston SC, Knoxville TN, Texas (3 locations), Charlottesville VA, Seattle WA, Milwaukee WI. Estimated primary completion date: December 2019. Trial suspended in June 2017 (“Company at this time unable to secure sufficient financial resources to complete”)
NCT02546102

A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma. St. Louis MO. Study start date: October 2015. Estimated primary completion date: May 2017.
NCT02510950

A Phase II Study of the Safety and Efficacy of SVN53-67/M57-KLH (SurVaxM) in Survivin-Positive Newly Diagnosed Glioblastoma. Buffalo NY, Cleveland OH. Estimated primary completion date: April 2017.
NCT02455557

Adjuvant Dendritic-Cell Immunotherapy Plus Temozolomide Following Surgery and Chemoradiation in Patients With Newly Diagnosed Glioblastoma (ADDIT-GLIO). Antwerp, Belgium. Estimated primary completion date: December 2017.
NCT02649582

An Open Label, Randomised, Phase II Study to Investigate the Efficacy and Safety of ALECSAT Treatment as an add-on Therapy to Radiotherapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma. Recruiting in Göteborg, Sweden. Estimated primary completion date: January 2020. ALECSAT is an acronym for Autologous Lymphoid Effector Cells Specific Against Tumor cells.
NCT02799238

Immune checkpoint inhibitors

A Phase II, Open-label, Single Arm, Multicenter Study of Avelumab [antibody against PD-L1] With Hypofractionated Radiation in Adult Subjects With Transformed IDH Mutant Glioblastoma. New York NY. Estimated primary completion date: February 2019.
NCT02968940

A Randomized Phase 3 Open Label Study of Nivolumab vs Temozolomide Each in Combination With Radiation Therapy in Newly Diagnosed Adult Subjects With Unmethylated MGMT Glioblastoma (CheckMate 498). Locations in the USA, Australia, Austria, Belgium, Canada, Germany, Netherlands, Poland, Spain, Switzerland, United Kingdom. Estimated primary completion date: March 2019.
NCT02617589

Phase I Study of Temozolomide in Combination With Ipilimumab and/or Nivolumab in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma. San Francisco CA, Atlanta GA, Bethesda MD, Boston MA, New York NY, Cleveland OH, Houston TX. Estimated primary completion date: May 2016.
NCT02311920

Suicide gene and immune-mediated gene therapy hybrid

Combined Cytotoxic and Immune-Stimulatory Therapy for Glioma (Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L gene therapy). Phase I. Ann Arbor, USA. Estimated primary completion date: December 2018.
For newly diagnosed patients who haven’t yet had surgery. This trial is focused on GBM. I was told by the trial contact person that if the patient has a pre-operative biopsy and results come back as anaplastic astrocytoma, the patient would most likely be excluded. On the other hand, if the intraoperative diagnosis of anaplastic astrocytoma is made, the patient would receive the shots regardless. If intraoperative diagnosis is low grade glioma, the patient will not receive the shots. This therapy was highly effective in a syngeneic rat glioma model. This trial is testing a dual gene therapy, using adenoviral vectors to deliver two therapeutic genes to the tumour cells. The adenoviral vectors are infused into the peritumoral area at the time of surgery. One of the therapeutic genes is herpes simplex virus thymidine kinase (HSV1-TK). This is a viral enzyme which converts an inactive prodrug (in this case valacyclovir, administered 1-3 days after adenoviral vector delivery) into a cytotoxic drug which inhibits DNA replication. The second gene, Flt3L, causes maturation and proliferation of dendritic cells and natural killer cells. It is thought that the HSV1-TK/valacyclovir mediated death of tumour cells will expose tumour antigens, activating a subsequent antitumour immune response which will be aided by the Flt3L gene. Standard radiation and chemotherapy will follow the experimental gene therapy. In a July 2017 publication, it was stated that “The trial involves 6 cohorts of 3 patients each, for a total of 18 patients, we have already completed treatment of the first cohort and treated on patient in the second cohort. We are aiming to complete the trial in 2018. Preliminary data of this ongoing trial will be presented during 2018.”
NCT01811992

Fluorescence-guided resection and Photodynamic Therapy

A Pilot Study of the Feasibility of Intraoperative Photodynamic Therapy of Glioblastoma. Single group, open label. Lille France. Estimated primary completion date: December 2019.
NCT03048240

Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial. Cleveland, Ohio, USA. Estimated primary completion date: May 2017.
NCT00752323

More trials of fluorescence-guided resection found on Currently Recruiting Trials for High Grade Glioma.

Recurrent and progressive

Vaccines and cell therapies – recurrent

A Randomized, Multicenter, Phase 2 Study of DSP-7888 Dosing Emulsion in Combination With Bevacizumab Versus Bevacizumab Alone in Patients With Recurrent or Progressive Glioblastoma Following Initial Therapy. Fayetteville, Arkansas. Estimated primary completion date: December 2019. DSP-7888 is a WT1 protein-derived peptide vaccine.
NCT03149003

A Phase I/II Clinical Trial of Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients. MD Anderson – Houston TX. Estimated primary completion date: June 2020.
For newly diagnosed GBM post-radiotherapy and temozolomide, and for recurrent GBM.
NCT02661282

Placebo-controlled
A Randomized, Double-blinded, Placebo-controlled Study of (ERC1671/GM-CSF/Cyclophosphamide) + Bevacizumab vs. (Placebo Injection/Placebo Pill) + Bevacizumab in the Treatment of Recurrent, Bevacizumab naïve Glioblastoma Multiforme Patients. University of California, Irvine. Estimated primary completion date: March 2019. For recurrent/progressive, bevacizumab-naïve glioblastoma multiforme and gliosarcoma.
NCT01903330

Oncolytic Virotherapy Trials – Recurrent

A Phase II, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) With Pembrolizumab (KEYTRUDA®) for Recurrent Glioblastoma or Gliosarcoma (CAPTIVE/KEYNOTE-192)
Recruiting in Salt Lake City UT, Little Rock AR, New York NY, Toronto Canada. Estimated primary completion date: December 2019.
NCT02798406

A Randomized Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (PVSRIPO) Alone or in Combination With Lomustine in Recurrent WHO Grade IV Malignant Glioma Patients. Duke University, North Carolina. Study start date: June 1 2017. Estimated primary completion date: May 2021.
NCT02986178

Immune enhancing drugs – Recurrent

A Phase I Trial of Anti-LAG-3 or Anti-CD137 (Urelumab) Alone and in Combination With Anti-PD-1 in Patients With Recurrent GBM. This is a dose finding study to find the maximum tolerated dose of the anti-LAG3 antibody, urelumab, and the combination of these with nivolumab. Estimated primary completion date: August 2018. Birmingham AL, Los Angeles CA, San Francisco CA, Baltimore MD, New York NY, Winston-Salem NC, Cleveland OH, Philadelphia PA, Pittsburgh PA.
NCT02658981

A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers. Detroit MI, San Antonio TX. Estimated primary completion date: March 2018.
NCT02526017

Gene therapy – Recurrent

Phase II Study of Combined Temozolomide and Targeted P53 Gene Therapy (SGT-53) for Treatment of Patients With Recurrent Glioblastoma. Houston TX. Estimated primary completion date: December 2017.
Prior chemotherapy for recurrent GBM with nitrosourea compounds including Gliadel® wafers or bevacizumab excluded
NCT02340156

Other

An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma. Phase 2, single group, open-label. San Francisco CA, Santa Monica CA, Boca Raton FL, New York NY, Durham NC, Cleveland OH, Columbus OH, Dallas TX, San Antonio TX. Estimated primary completion date November 2018.
NCT02858895

An Open-Label, Phase 1/2A Dose Escalation Study of Safety and Efficacy of NEO100 (Perillyl alcohol) in Recurrent Grade IV Glioma. Currently recruiting in Cleveland OH. Not yet recruiting at University of Southern California (Los Angeles), Seattle WA, Madison WI. Estimated primary completion date: June 2018.
NCT02704858

Phase 2 Study of Sym004 for Adult Patients With Recurrent Glioblastoma. “The purpose of this study is to assess the activity of Sym004, a recombinant antibody mixture that specifically binds to EGFR, in patients diagnosed with recurrent glioblastoma whose tumor is EGFR amplified.” Duke University. Estimated primary completion date: October 2018.
NCT02540161

Not yet recruiting

NCT00045968 DCVax (Autologous dendritic cells pulsed with tumor lysate) Y States: AR CA CO DC FL IL IN KS MA MI MN MO NJ NY NC OH PA RI SC TN TX WA; London, UK; Dresden, Germany glioblastoma ages 18-70 newly diagnosed 3 yes No September 2015 June 2014 300
ClinicalTrials.gov data Name of therapy Location of trial Tumor type Adult or child Newly diagnosed or recurrent Phase Requires tumor sample? Estimated primary completion date Last verified Estimated enrollment (patients)
NCT00045968 DCVax (Autologous dendritic cells pulsed with tumor lysate) States: AR CA CO DC FL IL IN KS MA MI MN MO NJ NY NC OH PA RI SC TN TX WA. London, UK glioblastoma ages 18-70 newly diagnosed 3 yes September 2014 December 2013 300
NCT01480479 Rindopepimut (EGFRvIII vaccine) States: AL AZ AR CA CT DE FL GA HI IL IA KY LA MD MA MI MN MO NE NH NJ NY NC OH OR PA SC TN TX UT VT VA WA WI. Australia Austria Belgium Brazil Canada Colombia Czech R. France Germany Greece Hungary India Israel Italy Mexico Netherlands NewZealand Peru Spain Switzerland Taiwan Thailand UK glioblastoma adult newly diagnosed 3 surgical resection required November 2016 February 2014 700
NCT01635283 Autologous dendritic cells pulsed with tumor lysate Jonsson Comprehensive Cancer Center (Los Angeles) grade 2 glioma adult either 2 yes December 2016 August 2013 18
NCT01204684 Autologous dendritic cells pulsed with tumor lysate, +/- resiquimod or POLY ICLC Jonsson Comprehensive Cancer Center (Los Angeles) grade III-IV glioma adult either 2 yes September 2014 August 2013 60
NCT01498328 Rindopepimut (EGFRvIII vaccine) plus bevacizumab (trial name ReACT) States: AL AZ CA CO FL GA IL MD MA MI MN MO NV NJ NY NC OH OR PA RI TX UT WA glioblastoma (EGFRvIII positive) adult recurrent 2 no June 2015 February 2014 168
NCT02017717 Nivolumab or Nivolumab Combined With Ipilimumab (Yervoy) Versus Bevacizumab States: CA CT FL GA MD MA NY NC TN. 4 locations in Italy glioblastoma adult recurrent 2 no January 2018 March 2014 260
NCT01814813 Bevacizumab with or without Heat Shock Protein-Peptide Complex-96 (Prophage) States: CA FL IL IN MI MO MT NE NC OH OK SC VA resectable glioblastoma adult recurrent 2 yes April 2016 September 2013 222
NCT01454596 T Cells Expressing Anti-EGFRvIII Chimeric Antigen Receptor NIH Clinical Center, Bethesda, MD glioblastoma, gliosarcome (EGRFvIII positive) 18-66 years recurrent or progressive 1/2 no September 2018 January 2014 160
NCT01920191 Intradermal IMA950 Peptide-based Vaccine plus Poly-ICLC University Hospital (Geneva, Switzerland) glioblastoma (HLA-A2 positive) adult newly diagnosed 1/2 no August 2014 August 2013 16
NCT01808820 Autologous tumor cells pulsed with tumor lysate University of Miami Sylvester Comprehensive Cancer Center grade III-IV glioma over age 13 recurrent 1 yes July 2018 February 2014 20
NCT01792505 Dendritic cells pulsed with tumor lysate, imiquimod cream Cedars-Sinai Medical Center (Los Angeles) malignant glioma adult 1 yes October 2014 February 2013 89
NCT01144247 Intratumoral Alloreactive Cytotoxic T Lymphocytes and Interleukin-2 Jonsson Comprehensive Cancer Center (Los Angeles) malignant glioma or meningioma adult recurrent 1 no; surgery required July 2015 August 2013 15
NCT01250470 SVN53-67/M57-KLH Survivin peptide vaccine Roswell Park Cancer Institute (Buffalo, New York) malignant glioma (survivin-positive) adult recurrent or progressive 1 no September 2014 February 2014 9
NCT01967758 ADU-623 (EGFRvIII vaccine) Providence Cancer Center (Portland, Oregon) grade III astrocytoma, glioblastoma adult after standard of care 1 tissue required for testing October 2016 October 2013 38
NCT02010606 Autologous Dendritic Cells Pulsed With Lysate Derived From an Allogeneic Glioblastoma Stem-like Cell Line Cedars-Sinai Medical Center (Los Angeles) glioblastoma adult either 1 no; post-surgery minimal residual tumor required October 2018 December 2013 40
NCT02049489 Autologous CD-133 DC Vaccine (ICT-121) Cedars Sinai Medical Center, Los Angeles glioblastoma (HLA A2 positive) ages 18-80 recurrent 1 no; post-surgery minimal residual tumor required January 2015 January 2014 20
NCT00890032 Dendritic cells loaded with brain tumor stem cell mRNA Duke University Medical Center, Durham, North Carolina, USA glioblastoma adult recurrent 1 yes September 2015 January 2014 50


This page was created on 03/04/2014 and last updated on 11/26/2016



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