Currently Recruiting Clinical Trials - Low Grade Glioma - 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.

Clinical trials for adult grade II glioma patients are few and far between. A search on the clinicaltrials.gov database turns up only a few results. In this section I'll be covering trials for adult WHO grade II astrocytoma, oligodendroglioma, and oligoastrocytoma.

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. Los Angeles CA, Nashville TN, Houston TX. 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). Randomized Phase III. Phoenix, Arizona, USA. Estimated primary completion date: December 2014. For newly diagnosed patients only.
NCT01502280

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

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. For newly diagnosed and recurrent cases.
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

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.

Safety and Feasibility of Transcranial MRI-Guided Focused Ultrasound Surgery in the Treatment of Brain Tumors. Phase I. Seattle WA. Estimated primary completion date: December 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. 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

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

Newly Diagnosed

Proton therapy

Note: these trials are for newly diagnosed or recurrent patients who haven't had prior 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. 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

A Phase II Study of Proton Radiotherapy for Pediatric Brain Tumors Requiring Partial Brain Irradiation. Boston, MA. Estimated primary completion date: January 2020. Ages 1-25.
NCT01288235

Recurrences

Immune therapies

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

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

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, Baltimore MD, New York NY, Nashville TN, Dallas TX, San Antonio TX, and Villejuif France. Estimated primary completion date: May 2016.
NCT02073994

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-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



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