Currently Recruiting Trials – High Grade Glioma

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

Page last updated April 25, 2017

New trials (added here in the last month)

Added April 25, 2017
A Phase I study of neural stem cell based virotherapy in combination with standard radiation and chemotherapy for patients with newly diagnosed malignant glioma. Chicago IL. Estimated primary completion date: March 2019.
NCT03072134

Added April 25, 2017
Phase I Study in Humans Evaluating the Safety of Rectus Sheath Implantation of Diffusion Chambers Encapsulating Autologous Malignant Glioma Cells Treated With Insulin-like Growth Factor Receptor-1 Antisense Oligodeoxynucleotide (IGF-1R/AS ODN) in 32 Patients With Newly Diagnosed Malignant Glioma. Philadelphia PA. Estimated primary completion date: December 2018.
NCT02507583

Added February 15, 2017
A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy (STELLAR). Multiple centers in the USA, Germany and Italy. Estimated primary completion date: June 2019. A prior phase 3 trial which recruited patients in the 1990s and published in 2003 tested PCV chemotherapy with or without eflornithine for anaplastic gliomas post-radiotherapy and showed a trend towards improved PFS and overall survival in the eflornithine group. For anaplastic astrocytomas, median PFS and OS was improved by more than two years in that trial. The current trial should provide a more fine-tuned outcome analysis with the aid of genetic markers (such as IDH1 mutation) which were not available to the former trial.
Orbus Therapeutics website
NCT02796261

Fluorescence-guided resection and improved intra-operative tumour visualization

A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients With Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study. Phase II. University of California San Diego CA, New York NY. Estimated primary completion date: December 2017.
NCT02632370

Fluorescence-guided Surgery for Low- and High-grade Gliomas (BALANCE). Phase III. Phoenix, Arizona, USA. Estimated primary completion date: January 2018.
NCT01502280

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 2018.
NCT01128218

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

5-ALA in Recurrent Glioma. Phoenix, Arizona, USA. A single-center, non-randomized, single-arm study. Estimated primary completion date: June 2017. Recurrent only.
NCT02119338

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

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 2017.
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: June 2021.
NCT01966809

Vaccines – recurrent

AVeRT: Anti-PD-1 Monoclonal Antibody (Nivolumab) in Combination With DC Vaccines for the Treatment of Recurrent Grade III and Grade IV Brain Tumors. Duke University, Durham NC. Estimated primary completion date: May 2018. For Avastin (bevacizumab) naïve patients only (no prior bevacizumab)
NCT02529072

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 (ΔactA/ΔinlB) 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

VXM01 Phase I Pilot Study in Patients With Operable Recurrence of a Glioblastoma to Examine Safety, Tolerability, Immune and Biomarker Response to the Investigational VEGFR-2 DNA Vaccine VXM01. Heidelberg, Germany. Estimated primary completion date: August 2017.
NCT02718443

T-cells – recurrent

Phase I Study of Cellular Immunotherapy Using Central Memory Enriched T Cells Lentivirally Transduced to Express an IL13Rα2-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

Virotherapy

Measles Virus Derivative (MV-CEA) in Patients With Recurrent Glioblastoma Multiforme [or malignant glioma]. Mayo Clinic, Rochester, Minnesota, United States. Phase I. Estimated primary completion date: June 2017. Bevacizumab not allowed less than 12 weeks prior to registration.
NCT00390299

Checkpoint inhibitors

Phase I Trial of Hypofractionated Stereotactic Irradiation (HFSRT) Combined With Nivolumab in Patients With Recurrent High Grade Gliomas. Tampa FL. Estimated primary completion date: April 2019.
NCT02829931

A Proof-of-Concept, Pilot Study of Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype. Memorial Sloan Kettering Cancer Center: Basking Ridge NJ, Commack NY, New York NY, West Harrison NY. Estimated primary completion date: January 2017.
NCT02658279

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

Immuno Gene Therapy

A Phase 1 Study of M032 (NSC 733972), a Genetically Engineered HSV-1 Expressing IL-12, in Patients With Recurrent/Progressive Glioblastoma Multiforme, Anaplastic Astrocytoma, or Gliosarcoma. University of Alabama. Estimated primary completion date: July 2017.
NCT02062827

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. Los Angeles CA, Stanford CA, Chicago IL, Boston MA. Estimated primary completion date: December 2017. 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.
News item
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: December 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 (ΔactA/ΔinlB) 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. Los Angeles CA, Nashville TN, Houston TX. 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

An Open-label, Non-randomized, Multicenter Phase I Study to Determine the Maximum Tolerated or Recommended Phase II Dose of Oral Mutant IDH1 Inhibitor BAY 1436032 and to Characterize Its Safety, Tolerability, Pharmacokinetics and Preliminary Pharmacodynamic and Anti-tumor Activity in Patients With IDH1-R132X-mutant Advanced Solid Tumors. Phase I. Recruiting in Santa Monica CA [USA], Denmark, and Germany. Not yet recruiting in Los Angeles CA. Estimated primary completion date: July 2018.
NCT02746081

Gene therapy

A Phase I Study of Cytosine Deaminase-Expressing Neural Stem Cells in Combination With Oral 5-Fluorocytosine and Leucovorin for the Treatment of Recurrent High-Grade Gliomas. Duarte, California, USA. Estimated primary completion date: October 2018.
NCT02015819

A Phase I Study of Intracranially Administered Carboxylesterase-Expressing Neural Stem Cells in Combination With Intravenous Irinotecan in Patients With Recurrent High-Grade Gliomas. Duarte, California. Estimated primary completion date: March 2019.
NCT02192359

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

Not yet recruiting

The Toca 7 Study: A Phase 1b Study of the Safety of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC in Subjects With Newly Diagnosed High Grade Glioma Receiving Standard of Care. Study start date: March 2016. Last verified December 2015.
NCT02598011