Currently Recruiting Clinical Trials - High Grade Glioma (WHO Grades III and IV) - Short List

by Stephen Western
Astrocytoma Options.com

Search brain tumor clinical trials by tumor type, age, country, state, zip code, and more HERE

This page is not a complete listing, but represents a selection of some of the most interesting trials with a focus on immunotherapy.

High grade glioma includes World Health Organization (WHO) grades III astrocytoma, oligodendroglioma, oligoastrocytoma and grade IV gliobastoma and gliosarcoma.

New Trials (added here in the last month)

Added June 25, 2015
Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation. Nashville TN. Estimated primary completion date: September 2018.
NCT02481154
Agios news release

Fluorescence-guided resection and improved intra-operative tumour visualization

Fluorescence-guided Surgery for Low- and High-grade Gliomas (BALANCE). Phase III. Phoenix, Arizona, USA. Estimated primary completion date: December 2015.
NCT01502280

A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Tumors of the Brain. San Francisco, California, USA. Estimated primary completion date: August 2015.
NCT01116661

A Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas. Atlanta, Georgia. Not yet recruiting in Ann Arbor and Detroit MI, and Saint Louis MO. Estimated primary completion date: September 2015.
NCT01445691

A Phase 1 and 2 Study of 5-aminolevulinic Acid (5-ALA) to Enhance Visualisation and Resection of Malignant Glial Tumors of the Brain. Springfield, Illinois. Estimated primary completion date: June 2015.
NCT01128218

Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas. Baltimore, Maryland, USA. Estimated primary completion date: December 2015.
NCT01502605

Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection. Phase I. Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire. Estimated primary completion date: July 2019.
NCT02191488

A Phase 1 Dose Escalation/Expansion Study of BLZ-100 Administered by Intravenous Injection in Adult Subjects With Glioma Undergoing Surgery. Cedars-Sinai Medical Center (Los Angeles, CA), and Brisbane Australia. Estimated primary completion date: September 2015.
NCT02234297

5-ALA in Recurrent Glioma. Phoenix, Arizona, USA. A single-center, non-randomized, single-arm study. Estimated primary completion date: July 2015. Recurrent only
NCT02119338

MRI-Guided Focused ultrasound

MRI-guided focused ultrasound therapy is generally being tested for brain tumours that are internally located and inaccessible to surgical resection.

MR-guided Ultrasound-Neurosurgery for the Treatment of Malignant Brain Tumors. Phase I. Zurich, Switzerland. Estimated primary completion date: December 2015. For patients with a malignant glioma or a recurrent glioma, that do not accept a conventional tumor resection or where a conventional tumor resection is not indicated. Targeted tumor volume has in all directions a distance of at least 2.5 cm from the inner table of the skull.
NCT01698437

Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors. Phase I. Seattle WA and Boston MA. Estimated primary completion date: December 2014. Last verified November 2014.
NCT00147056

ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors. A safety and feasibility study. Toronto, Canada. Estimated primary completion date: December 2015. Recurrent or progressive tumours only. This treatment will be offered as an option for those patients where neither surgery or repeat radiotherapy is advised by the multidisciplinary team. The targeted tumor tissue is located in the cerebral hemispheres, > 2.5 cm from the inner table of the skull.
NCT01473485

Newly diagnosed

Vaccines

Targeting IDH1R132H in WHO Grade III-IV IDH1R132H-mutated Gliomas by a Peptide Vaccine - a Phase I Safety, Tolerability and Immunogenicity Multicenter Trial (NOA-16). 8 locations in Germany. Study start date: June 2015. Estimated primary completion date: August 2018. Vaccination begins either 4-6 weeks post-radiotherapy, or during the fourth monthly cycle of follow-up temozolomide.
NCT02454634

Pre-surgery Imaging

A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection. Vancouver BC. Estimated primary completion date: December 2015.
NCT01248754

Proton radiation therapy

Proton Radiation Therapy for Low Grade and Favorable Grade 3 Gliomas. Phase II. The "favorable" descriptor in the title refers to grade III patients with either IDH1 mutation or codeletion of chromosomes 1p and 19q. This is a single-centre study being conducted at the Massachusetts General Hospital in Boston. Proton therapy is a form of radiation which reduces damage to surrounding tissues. Patients receive a total of 54 Gy of radiation over a course of six weeks. Estimated enrollment is 40 patients and estimated primary completion date is May 2015.
NCT01358058

Recurrent and progressive

Photodynamic therapy and surgery

A Phase II Study of Photodynamic Therapy (PDT) With Photofrin® (IND 104,613) For Recurrent High Grade Gliomas in Adults. Milwaukee USA. Estimated primary completion date: December 2018.
NCT01966809

Vaccines - recurrent

Dendritic Cell Vaccine For Relapsed Malignant Glioma and Glioblastoma Multiforme in Adult and Pediatric Subjects. Phase I. This is a phase I trial conducted by the University of Miami Sylvester Comprehensive Cancer Center. Vaccine preparation involves dendritic cells loaded with tumor lysate. Patients in this trial will also have imiquimod cream (an immune stimulant) applied topically. Patients must have undergone or undergo a surgical resection to obtain tumor material, and also a leukapheresis procedure to obtain dendritic cells from the patients' blood. The trial is open to patients with recurrent high grade gliomas, including patients originally diagnosed with a grade II glioma, but recurrent as a grade III or glioblastoma (grade IV). Estimated primary completion date: July 2018.
NCT01808820

Phase I Study of Safety and Immunogenicity of ADU-623, a Live-attenuated Listeria Monocytogenes Strain (?actA/?inlB) Expressing the EGFRvIII-NY-ESO-1 Vaccine, in Patients With Treated and Recurrent WHO Grade III/IV Astrocytomas. Portland, Oregon, USA. Estimated primary completion date: October 2016.
For patients who have completed the standard of care (ie radiation, chemotherapy).
NCT01967758

T-cells - recurrent

Tumor-Associated Antigen (TAA)-Specific Cytotoxic T-Lymphocytes Administered to Patients with Solid Tumors. Phase I. Houston, Texas. For patients with solid tumours progressive or recurrent after first-line therapy. Tumours must express one of the following antigens: PRAME, SSX2, MAGEA4, NY-ESO1-1 and/or Survivin. Estimated primary completion date: December 2017.
NCT02239861

Phase I Study of Cellular Immunotherapy Using Central Memory Enriched T Cells Lentivirally Transduced to Express an IL13Ra2-Specific, Hinge-Optimized, 41BB-Costimulatory Chimeric Receptor and a Truncated CD19 for Patients With Recurrent/Refractory Malignant Glioma. Duarte, California. Estimated primary completion date: December 2018.
NCT02208362

Immune-modifying drugs

A Phase I and Open Label, Randomized, Controlled Phase II Study Testing the Safety, Toxicities, and Efficacy of MK-3475 (pembrolizumab, anti-PD-1 antibody) in Combination With MRI-guided Laser Ablation in Recurrent Malignant Gliomas. St. Louis, MO. Estimated primary completion date: June 2018.
Prior treatment with any anti-angiogenic agent (including bevacizumab) excluded.
NCT02311582

A Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) With Pembrolizumab and Bevacizumab in Patients With Recurrent High Grade Gliomas. Tampa FL. Estimated primary completion date: June 2017.
NCT02313272

Study of IDO Inhibitor (indoximod) and Temozolomide for Adult Patients With Primary Malignant Brain Tumors. Tampa FL, Athens GA, Augusta GA, Chicago IL, Iowa City IA, Minneapolis MN, Salt Lake City UT, Fairfax VA, USA. Phase I/II. Estimated primary completion date: December 2015. Phase 1b portion open to progressive (following radiation or chemoradiation) grade III and IV glioma patients. Phase 2 open to temozolomide refractory glioblastoma or gliosarcoma (grade IV) patients.
NCT02052648

Immuno Gene Therapy

Ad-RTS-hIL-12, an Inducible Adenoviral Vector Engineered to Express hIL-12 in the Presence of the Activator Ligand Veledimex in Subjects With Recurrent or Progressive Glioblastoma or Grade III Malignant Gliomas. Estimated primary completion date: December 2016. This therapy uses a virus to deliver a gene for interleukin-12 (a key cytokine for type 1 immune responses) into the tumor, which is controllable by a "gene switch" which can be turned on by the oral administration of veledimex. Essentially this therapy is a means to control levels of interleukin-12 in the tumor, thereby influencing immune responses. "The study is expected to enroll up to 72 subjects at up to 12 leading treatment centers. Among the centers expected to begin enrollment are the Stanford School of Medicine, Dana Farber/Brigham and Women's, the University of Chicago Pritzker School of Medicine, Cedars-Sinai/the David Geffen School of Medicine at the University of California, Los Angeles, and Northwestern Memorial Hospital."
Source
NCT02026271

Anti-EGFRvIII therapies

(EGFRvIII is a mutation associated with "classical" type glioblastoma)

A Phase I/II Study of the Safety and Feasibility of Administering T Cells Expressing Anti-EGFRvIII Chimeric Antigen Receptor to Patients With Malignant Gliomas Expressing EGFRvIII. Bethesda, Maryland, USA. Estimated primary completion date: September 2018.
For patients with recurrent or progressive disease following radiotherapy.
NCT01454596

Phase I Study of Safety and Immunogenicity of ADU-623, a Live-attenuated Listeria Monocytogenes Strain (?actA/?inlB) Expressing the EGFRvIII-NY-ESO-1 Vaccine, in Patients With Treated and Recurrent WHO Grade III/IV Astrocytomas. Portland, Oregon, USA. Estimated primary completion date: October 2016.
For patients who have completed the standard of care (ie radiation, chemotherapy).
NCT01967758

Targeting mutant IDH1 or IDH2

Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation. Nashville TN. Estimated primary completion date: September 2018.
NCT02481154
Agios news release

A Phase I Study of IDH305 in Patients With Advanced Malignancies That Harbor IDH1R132 Mutations. Recruiting in Houston TX, Melbourne Australia, Toronto Canada, and Singapore. Not yet recruiting in Boston MA, New York NY, Parkville Australia, Leuven Belgium, Heidelberg and Jena Germany, Amsterdam and Rotterdam Netherlands, and Barcelona Spain. Estimated primary completion date: November 2017.
NCT02381886

Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation. For recurrent IDH1 mutant tumours, currently recruiting in Scottsdale AZ, Los Angeles CA, Aurora CO, Miami FL, Boston MA, New York NY, Nashville TN, Dallas TX, San Antonio TX, and Villejuif France. Location in Baltimore MD not yet recruiting as of January 20, 2015. Estimated primary completion date: May 2016.
NCT02073994

Orally Administered AG-221 in Subjects With Advanced Solid Tumors, Including Glioma, and With Angioimmunoblastic T-cell Lymphoma, With an IDH2 Mutation. Phase I/II. Currently recruiting in Nashville TN. Not yet recruiting in Scottsdale AZ, Los Angeles CA, Miami FL, Boston MA, Omaha NE, New York NY, Dallas TX, and Villejuif France. Estimated primary completion date: June 2016.
NCT02273739

Gene therapy

See the Toca 511 & Toca FC page for more complete description of this therapy.

Toca 511 & Toca FC: Retroviral Replicating Vector Administered to Subjects With Recurrent Malignant Glioma. Phase I. This trial is similar in all respects to the one outlined above, except patients in this trial do not undergo surgery, instead receiving a transcranial injection of Toca 511 into the tumour with a biopsy needle. This trial is enrolling patients in Duarte CA, Los Angeles CA, San Diego CA, San Francisco CA, Detroit MI, Hackensack NJ, Cleveland OH, Columbus OH, Pittsburgh PA, and Houston TX. Estimated primary completion date: May 2015.
NCT01156584

Toca 511, a Retroviral Replicating Vector, Administered Intravenously Prior to, and Intracranially at the Time of, Subsequent Resection for Recurrent HGG & Followed by Treatment With Extended-Release 5-FC. Phase I. Toca 511 & Toca FC is an innovative and promising therapy described in two trials, above, and on the Toca 511 & Toca FC page on this site. This trial differs from the other two phase I trials in that half of the Toca 511 dose is delivered intravenously, later followed by direct injection into the tumour at the time of surgery. This trial is recruiting at UCLA in Los Angeles, Detroit MI, and Cleveland OH. Estimated primary completion date: October 2015.
NCT01985256

Genetically Modified Neural Stem Cells, Flucytosine, and Leucovorin Calcium in Treating Patients With Recurrent High-Grade Gliomas. Duarte, California, USA. Estimated primary completion date: October 2018.
NCT02015819

Other - Recurrent

Phase I Single-Center, Dose Escalation Study of D2C7-IT Administered Intratumorally Via Convection-Enhanced Delivery for Adult Patients With Recurrent Malignant Glioma. Duke University. Estimated primary completion date: June 2017. D2C7 targets both wild-type EGFR and EGFRvIII.
NCT02303678

This page was created on 01/26/2014 and last updated on 04/21/2019