CURRENT RECRUITING TRIALS

GCAR - AGILE (Glioblastoma)

GBM AGILE: An international, seamless phase II/III response adaptive randomization platform trial designed to evaluate multiple regimens in Newly Diagnosed and Recurrent Glioblastoma (GBM)

From clinicaltrials.gov

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

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INTRAGO II (Glioblastoma)

A Multicenter, Randomized Phase III Study on Intraoperative Radiotherapy in Newly Diagnosed Glioblastoma multiforme:–>

From clinicaltrials.gov:

INTRAGO II resembles a multicentric, prospective, randomized, 2-arm, open-label clinical phase III trial which tests if the median progression-free survival (PFS) of patients with newly diagnosed glioblastoma multiforme (GBM) can be improved by the addition of intraoperative radiotherapy (IORT) to standard radiochemotherapy.

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RAMAN SPECTROSCOPY

Development of a guiding device based on Raman spectroscopy for the accurate intraoperative identification of tumoral tissue during surgical resection of brain tumours 

In this clinical study, a probe  developed by the Reveal Surgical will be used in conjunction with a measuring device developed at the Laboratory of Radiological Optics (LRO) at Polytechnique Montreal to develop a new tool to help guide surgeons during brain tumour surgery.  

This tool is based on a technology called “Raman spectroscopy”, which uses light to retrieve information about the brain. The surgeon holds a stylus that shines a small beam of light on the brain, and by analyzing the light that comes back from the brain, the Raman device provides information about the composition of the brain tissue. This composition is different between normal and cancerous brain tissue. Eventually, these readings on the brain with the new Raman device could help the surgeon decide more easily which tissue to remove during surgical resection of brain tumours. 

UPCOMING TRIALS

NovoCure EF41-KEYNOTE D58

Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (EF-41)

This is a multicenter, two-arm, randomized, double-blind, placebo-controlled study of Optune® (Tumor Treating Fields at 200 kHz) together with maintenance Temozolomide (TMZ) chemotherapy agent and pembrolizumab compared to Optune® together with maintenance TMZ and placebo in newly diagnosed Glioblastoma (GBM) patients. The primary objective of the study is to evaluate the Overall Survival (OS).
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Optune® (TTFields, 200 kHz) Concomitant With Maintenance Temozolomide and Pembrolizumab Versus Optune® Concomitant With Maintenance Temozolomide and Placebo for the Treatment of Newly Diagnosed Glioblastoma (EF-41/KEYNOTE D58).

ACTIVE TRIALS

ORBUS (Astrocytoma)

A Phase 3, Randomized, 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

The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

This study will consist of 4 study periods of up to 50 months in total, consisting of:Screening Period – A maximum screening duration of 4 weeks.

Treatment Period – Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.

End of Treatment Visit – A minimum of 4 weeks post last treatment for both arms.

Follow-Up Period – Up to 24 months.

A total of approximately 280 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.

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THE TEAM

Dr. Kevin Petrecca

Dr. Kevin Petrecca

Principal Investigator

Dr. B. Abdulkarim

Dr. B. Abdulkarim

Principal Investigator

Mostafa Ghozlan

Mostafa Ghozlan

Team Lead

THE TEAM

Dr C. Couturier

Dr C. Couturier

Principal Investigator

Dr. Scott Owen

Dr. Scott Owen

Principal Investigator

Rick Sanchez

Rick Sanchez

Clinical Research Coord.