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Brain and Spine Tumors Clinical Trials

A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil) to Reduce Cancer-Related Fatigue in Patients with Glioblastoma Multiforme
Aims:
The purpose of this study is to determine if taking the drug armodafinil will improve problems with fatigue in patients with glioblastoma and to evaluate the effects of taking armodafinil as compared to placebo on cancer related fatigue and on cognitive function.
Principal Investigator:
Ryan T. Merrell, MD
IRB Approval Number:
EH13-248
Contact:
Please call 847.570.2025 with questions regarding the study.
Open to Enrollment:
Yes

Expanded Access (Compassionate Use) Treatment Protocol Rindopepmut (CDX110)
Aims: This protocol has been developed to offer expanded access to rindopepimut to patients who do not qualify for enrollment into an open trial of rindopepimut or where the closest open clinical trial site is geographically inaccessible.
Principal Investigator: Ryan Merrell, MD
IRB Approval Number: EH12-370
Contact: Please call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes

Yellow 560 Microscope for Intraoperative Visualization of Fluorescein Stained High Grade Gliomas
Aims: The purpose of this study is to assess the use of a yellow, fluorescent dye in combination with a specialized microscope during brain surgery for the removal of a specific type of tumor called a high-grade glioma. Objectives include measuring patient outcomes and measuring the extent of tumor removal.
Principal Investigator: Julian Bailes, MD
IRB Approval Number:
EH13-331
Sponsor:
NorthShore University HealthSystem
Contact:
Please call 847.570.4224 with questions regarding the study.
Open to Enrollment:
Yes

A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy
Aims: The primary objective is to determine the overall survival of subjects treated with ICT-107 and SOC (RT and temozolomide) vs. placebo control and SOC (RT and temozolomide
Principal Investigator: Ryan Merrell, MD
IRB Approval  Number: EH15-230
Contact: Please call 847.570.2025 with questions regarding the study.
Open to Enrollment: Yes

A Randomized, Placebo Controlled Phase 2b/3 Study of ABT-414 with Concurrent Chemoradiation and Adjuvant Temozolomide in Subjects with Newly Diagnosed Glioblastoma (GBM) with Epidermal Growth Factor Receptor (EGFR) Amplification (Intellance 1)
Aims: The primary objective of Phase 2b is to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs Progression Free Survival (PFS) among subjects with newly diagnosed GBM harbouring EGFR amplification. The primary objective of Phase 3 is to determine whether the addition of ABT-414 to concomitant radiotherapy and temozolomide plus adjuvant temozolomide prolongs Overall Survival (OS) among subjects with newly diagnosed GBM harbouring EGFR amplification.
Principal Investigator: Ryan Merrell, MD
IRB Approval Number: EH16-003
Contact: Please call 847.570.2025 with questions regarding the study.
Open to Enrollment: Yes

Compassionate Use of ABT-414 for the Treatment of Glioblastoma Multiforme
Aims: The purpose of this study is to provide the drug currently being studied in an ongoing research study to patients who do not meet criteria to participate in the main study.
Principal Investigator: Ryan Merrell, MD
IRB Approval Number: EH16-225
Contact: Please call 847.570.2025 with questions regarding the study.
Open to Enrollment: Yes