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Brain & Spine Tumors 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
NorthShore Project Number:
EH13-248
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
NorthShore Project Number:
EH13-331
Sponsor:
NorthShore University HealthSystem
Contact:
Please call 847.570.4224 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
NorthShore Project Number: EH16-225
Contact: Please call 847.570.2025 with questions regarding the study.
Open to Enrollment: Yes

A Phase 2/3 Randomized, Open-Label Study of Toca 511, A Retroviral Replicating Vector, Combined with Toca FC versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma
Aims: The purpose of this study is to compare the overall survival of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumor resection for recurrence of glioblastoma or anaplastic astrocytoma.
Principal Investigator: Ryan Merrell, MD
NorthShore Project Number: EH15-156
Contact: Call 847.570-2025 with questions regarding the study.
Open to Enrollment: Yes

A Study of Exploratory Biomarkers in EGFR-Amplified Patient-Derived Xenograft (PDX) Models from Subjects with Glioblastoma Multiforme (GBM) Clinical Study Protocol F15-712
Aims: The purpose of this study is to collect tumor tissue from patients who will receive ABT-414 on the Compassionate Use protocol for use in pre-clinical tumor models.
Principal Investigator: Ryan Merrell, MD
NorthShore Project Number: EH17-148
Contact: Call 847.570.2025 with questions regarding the study.
Open to Enrollment: Yes

Phase I Study of Safety and Tolerability of Acetazolamide With Temozolomide
Aims: This is a Phase I study that examines the rate of dose limiting side effects in patients with malignant astrocytoma treated with combination acetazolamide (ACZ) and temozolomide (TMZ). Eligible patients must have histologically proven newly diagnosed, O6-methylguanine-DNA methyltransferase (MGMT) methylated WHO grade III or IV astrocytoma and be planning to undergo treatment with standard adjuvant TMZ (after completing treatment with TMZ and ionizing radiation).
Principal Investigator: Ryan Merrell, MD
NorthShore Project Number: EH18-083
Contact: Call 847.570.2025 with questions regarding the study.
Open to Enrollment: Yes

Phase 3b Study for Management of Occular Side Effects in Subjects with EGFR-amplified Glioblastoma Receiving Depatuxizumab Mafodotin (ABT-414)
Aims: This study will evaluate the effect of several ophthalmologic prophylactic treatment strategies for the management of ocular side effects in participants with epidermal growth factor receptor-amplified glioblastoma who are being treated with depatuxizumab mafodotin (ABT-414). The study will include 2 phases during the treatment period: chemoradiation therapy (radiation plus temozolomide [RT/TMZ]) and adjuvant therapy (TMZ). All participants will receive depatuxizumab mafodotin during both phases of the treatment period plus 1 of 3 prophylactic ophthalmologic treatments (standard steroids, standard steroids with vasoconstrictors and cold compress, and enhanced steroids with vasoconstrictors and cooling compress).
Principal Investigator: Ryan Merrell, MD
NorthShore Project Number: EH18-096
Contact: Call 847.570.2025 with questions regarding the study
Open to Enrollment: Yes