Currently Recruiting Clinical Trials - Low Grade Glioma
Braintumor Website

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.

Page last updated: September 24, 2017

New Trials (Added here in the last month)

Added September 24, 2017
Phase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors. Single group, open-label. Locations in Los Angeles, Santa Monica, Denmark, and Germany. Not yet recruiting in Japan. Estimated primary completion date: December 2018.
NCT02746081

Added September 24, 2017
A Single-Center, Open-Lable, Randomized Phase II Study of NovoTTF-200A (Optune) Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas. Santa Monica, California. Estimated primary completion date: 2021.
NCT02507232

Added September 24, 2017
Expanded Access to VAL-083. “This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria.
NCT03138629

Newly Diagnosed

Pilot Randomized Neo-adjuvant Evaluation of Agonist Anti-CD27 Monoclonal Antibody Varlilumab on Immunologic Activities of IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG). University of California San Francisco. Estimated primary completion date: January 2018.
NCT02924038

Pilot Randomized Neo-adjuvant Evaluation of Poly-ICLC-Assisted Tumor Lysate Vaccines [GBM6-AD lysate protein and poly-ICLC] in Adult Patients With WHO Grade II Glioma. University of California San Francisco. Estimated primary completion date: September 2018. For newly diagnosed or recurrent grade II glioma (astrocytoma, oligodendroglioma, oligoastrocytoma).
NCT02549833

A Single-Center, Open-Lable, Randomized Phase II Study of NovoTTF-200A (Optune) Alone and Combined With Temozolomide in Patients With Low-Grade Gliomas. Santa Monica, California. Estimated primary completion date: 2021.
NCT02507232

Proton therapy

A Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients With IDH Mutant, Low to Intermediate Grade Gliomas. Randomized, open-label. Philadelphia PA. Estimated primary completion date: 2022.
NCT03180502

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 2017.
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

Pilot Randomized Neo-adjuvant Evaluation of Agonist Anti-CD27 Monoclonal Antibody Varlilumab on Immunologic Activities of IMA950 Vaccine Plus Poly-ICLC in Patients With WHO Grade II Low-Grade Glioma (LGG). University of California San Francisco. Estimated primary completion date: January 2018.
NCT02924038

Pilot Randomized Neo-adjuvant Evaluation of Poly-ICLC-Assisted Tumor Lysate Vaccines [GBM6-AD lysate protein and poly-ICLC] in Adult Patients With WHO Grade II Glioma. University of California San Francisco. Estimated primary completion date: September 2018. For newly diagnosed or recurrent grade II glioma (astrocytoma, oligodendroglioma, oligoastrocytoma).
NCT02549833

A Pilot Study to Evaluate the Effects of Imiquimod and Tumor Lysate Vaccine Immunotherapy for Adults With High Risk or Recurrent/Post-Chemotherapy WHO Grade II Gliomas. Pittsburgh PA. Estimated primary completion date: September 2016. High-risk in this trial is defined as any of the following: age 40 or over; imcomplete resection; preoperative tumor diameter over 4 cm.
NCT01678352

RESIST: Patients With IDH1 Positive Recurrent Grade II Glioma Enrolled in a Safety and Immunogenicity Study of Tumor-Specific Peptide Vaccine. Duke University, Durham, North Carolina. Estimated primary completion date: May 2017.
NCT02193347

Targeting mutant IDH1 or IDH2

Phase I Study of BAY1436032 in Isocitrate Dehydrogenase-1 (IDH1)-Mutant Advanced Solid Tumors. Single group, open-label. Locations in Los Angeles, Santa Monica, Denmark, and Germany. Not yet recruiting in Japan. Estimated primary completion date: December 2018.
NCT02746081

Study of Orally Administered AG-881 in Patients With Advanced Solid Tumors, Including Gliomas, With an IDH1 and/or IDH2 Mutation. Recruiting in Los Angeles CA, San Francisco CA, Miami FL, Boston MA, New York NY, Durham NC, Nashville TN, Dallas TX, 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. USA, Australia, Belgium, Canada, Germany, Netherlands, Singapore, Spain. Suspended as of August 2017.
NCT02381886

PARP inhibitors

A Phase 2 Study of the PARP Inhibitor Olaparib (AZD2281) in IDH1 and IDH2 Mutant Advanced Solid Tumors. Not yet open as of September 2017. Phase 2, single group. Yale University, Connecticut. Start date: March 2018.
NCT03212274

Other

Expanded Access to VAL-083. “This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to VAL-083 (dianhydrogalactitol) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient’s medical history and program eligibility criteria.
NCT03138629




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