Neoplasms

All Conditions

Nervous System Diseases

Musculoskeletal Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Glioblastoma

Glioma

Neurilemmoma

Brain Neoplasms

Central Nervous System Neoplasms

Medulloblastoma

Meningioma

Nervous System Neoplasms

Spinal Cord Neoplasms

Pinealoma

Astrocytoma

Ependymoma

Craniopharyngioma

Adamantinoma

Neuroma, Acoustic

Germ Cells Tumors

Schwannoma

Pineocytoma

Acoustic Neuroma

Pineoblastoma

Oligoastrocytoma

tozuleristide 24 or 36 mg administered intravenously 1-24 hours prior to surgery

tozuleristide

imaging device attached to surgical microscope

Canvas imaging system

Standard of care surgical resection of tumor

Surgical resection of tumor

Clinical Trial Navigator

Ray Chu, MD

Chirag Patil, MD

Jeremy Rudnick, MD

Jethro Hu, MD

Serguei Bannykh, MD, PhD

John Yu, MD

The purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the Canvas imaging system during surgical resection of primary central nervous system (CNS) tumors: Primary gadolinium enhancing (high grade) CNS tumors, primary non-gadolinium enhancing CNS tumors, and primary vestibular schwannoma.

The primary objectives of the study is to see how well tozuleristide and the Canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade CNS tumors; and among the tumors that demonstrate tozuleristide fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue.

The secondary objectives of the study include evaluating the safety of tozuleristide and the Canvas imaging system, and to determine if the presence of remaining fluorescence at the time of surgery corresponds to remaining tumor evident on post-operative MRI images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (MRI).

Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System

A Phase 2 Study of Fluorescence Detection of Adult Primary Central Nervous System Tumors in Subjects Receiving Tozuleristide and Imaged With the Canvas System

Recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5

Blaze Bioscience Inc.

John Yu

Director, Surgical Neuro-Oncology

Symptoms and General Pathology

Recurrence

Disease Attributes

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Activated T cells (ATC) administered intravenously at one timepoint

Activated T cells

Kortnee Calkins

Justin Darrah, MD

The purpose of this study is to examine the use of activated T cells (ATCs) to assess the safety and tolerability of autologous activated T cells, as measured by the number of Grade 3 or higher toxicities, the number of serious adverse events, and treatment-related toxicities, according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version 5, to find the maximum tolerated dose. The secondary objectives include evaluating the rate of overall survival, rate of progression-free survival, health-related quality of life parameters, overall response rate, immune response, and tumor stem cell antigen expression.

Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma

A Phase I Trial of Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma

Recorded and graded according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5

Measured by change in the Functional Assessment of Cancer Therapy - Brain (FACT-Br) survey score. The FACT-Br total score has a range of 0-200 and higher scores indicate better quality of life

Percentage of patients showing either partial response or complete response, in patients with subtotal resection, will be measured using Magnetic Resonance Imaging (MRI) and Immunotherapy Response Assessment in Neuro-Oncology (iRANO) Response Criteria

Assessed by cytotoxic T cell activity in vitro pre- vs post-infusion.

Assessed by quantitative PCR for expression of CD133, housekeeping genes, and tumor associated antigens (including HER2, TRP-2, gp100, MAGE-1, IL13Rα2, AIM-2).

Kairos Pharma

Jeremy Rudnick, M.D

Co-Director, Neuro-Oncology

Behaviors and Mental Disorders

Disease Progression

Brain Diseases

Central Nervous System Diseases

Quality of Life

Supramaximal resection: maximal resection of the contrast-enhancing and non-contrast-enhancing part of the tumor (FLAIRectomy)

Maximal safe resection of the contrast-enhancing part of the tumor

Supramaximal resection. Tumor resection continues until either the FLAIR abnormalities have been resected based on the neuronavigation (after updating the navigation intraoperatively), or when subcortical tracts are identified with intraoperative stimulation.

Supramaximal resection

Maximal safe resection. Tumor resection continues until maximal safe resection has been achieved as by the neurosurgeon's opinion.

Maximal safe resection

Jasper Gerritsen, MD PhD

Arnaud Vincent, MD PhD

Mitchel Berger, MD

Brian Nahed, MD

Steven De Vleeschouwer, MD PhD

Christine Jungk, MD PhD

Sandro Krieg, MD MBA

Arthur Wagner, MD PhD

Marike Broekman, MD PhD

Philippe Schucht, MD PhD

A greater extent of resection of the contrast-enhancing (CE) tumor part has been associated with improved outcomes in high-grade glioma patients. Recent results suggest that resection of the non-contrast-enhancing (NCE) part might yield even better survival outcomes (supramaximal resection, SMR). Therefore, this study evaluates the efficacy and safety of SMR with and without mapping techniques in HGG patients in terms of survival, functional, neurological, cognitive, and quality of life outcomes. Furthermore, it evaluates which patients benefit the most from SMR, and how they could be identified preoperatively.

This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be operated with supramaximal resection or maximal resection at a 1:3 ratio. Primary endpoints are: 1) overall survival and 2) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months, and 6 months postoperatively. Secondary endpoints are 1) residual CE and NCE tumor volume on postoperative T1-contrast and FLAIR MRI scans 2) progression-free survival; 3) onco-functional outcome, and 4) quality of life at 6 weeks, 3 months, and 6 months postoperatively.

The study will be carried out by the centers affiliated with the European and North American Consortium and Registry for Intraoperative Mapping (ENCRAM).

This is an international, multicenter, prospective, observational, 2-arm cohort study (registration: clinicaltrials.gov ID number TBA). Eligible patients are operated with supramaximal resection versus maximal resection with a 1:3 ratio with a sequential computer-generated random number as subject ID. Intraoperative mapping techniques and/or surgical adjuncts can be used in both treatment arms to ensure the safety of the resection (to minimize the risk of postoperative deficits). Supramaximal resection is defined as 0 cm3 CE tumor and 5 cm3 or less NCE tumor, whereas maximal resection is defined as 0 cm3 CE tumor and \>5 cm3 NCE tumor (in line with the updated RANO criteria).

Study patients are allocated to either the supramaximal or maximal safe resection group and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, and 6 months postoperatively. Motor function will be evaluated using the NIHSS (National Institute of Health Stroke Scale) scale. Language function will be evaluated using a standard neurolinguistic test-battery consisting of the Aphasia Bedside Check (ABC), Shortened Token test, Verbal fluency, Picture description and Object naming. Cognitive function will be assessed using the Montreal Cognitive Assessment (MOCA). Patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system. Health-related quality of life (HRQoL) will be assessed with the EORTC QLQ C30, EORTC QLQ BN20 and EQ 5D questionnaires. Overall survival and progression-free survival will be assessed. We expect to complete patient inclusion in 4 years. The estimated duration of the study (including follow-up) will be 5 years.

The primary study objective is to evaluate the safety and efficacy of supramaximal resection versus safe maximal resection in HGG patients as measured by overall survival (OS) and postoperative NIHSS deterioration. Secondary study objectives are to evaluate extent of resection of CE and NCE tumor, quality of life, progression-free survival (PFS), onco-functional outcome (OFO), and SAEs after SMR or maximal safe resections as measured by volumetric analyses of contrast-enhanced MRI images with gadolinium combined with FLAIR images, tumor progression on MRI scans, quality of life questionnaires (EORTC QLQ C30, EORTC QLQ BN20, EQ 5D), combining postoperative residual volume with NIHSS outcomes, and recording SAEs respectively.

Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.

The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

The SUPRAMAX-study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)

Time from diagnosis to death from any cause

NIHSS deterioration of 1 point or more at 6 weeks after surgery

NIHSS deterioration of 1 point or more at 3 months after surgery

NIHSS deterioration of 1 point or more at 6 months after surgery

Time from diagnosis to disease progression (occurrence of a new tumor lesions with a volume greater than 0.175 cm3, or an increase in residual tumor volume of more than 25%) or death, whichever comes first

Residual tumor volume of the contrast-enhancing and non-contrast enhancing part, as assessed by a neuroradiologist on postoperative MRI scan (T1 with contrast and FLAIR sequences) using manual or semi-automatic volumetric analyses (Brainlab Elements iPlan CMF Segmentation, Brainlab AG, Munich, Germany; or similar software)

According to the OFO classification, consisting of the combination of presence/absence of functional deterioration with gross-total resection

Quality of life as assessed by the EORTC QLQ C30 questionnaire

Quality of life as assessed by the EORTC QLQ BN20 questionnaire

Quality of life as assessed by the EQ-5D questionnaire

Serious Adverse Events within 6 weeks postoperatively

Haaglanden Medical Centre

Universitaire Ziekenhuizen KU Leuven

University Hospital Heidelberg

Technical University of Munich

Insel Gruppe AG, University Hospital Bern

Massachusetts General Hospital

University of California, San Francisco

Jasper Gerritsen

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Immunomodulating Agents

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks

Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7

Stereotactic Radiation Therapy

Standard of care surgical resection of tumor on Day 10-28

Surgical Resection

Clinical Trial Recruitment Navigator

Stephen Shiao, MD, PhD

Keith Black, MD

Adam Mamelak, MD

Amin Mirhadi, MD

Behrooz Hakimian, MD

Chirag G Patil, MD, MS

The purpose of this study is to assess the safety/tolerability/feasibility of pembrolizumab and radiation therapy before surgical resection in patients with recurrent glioblastoma as defined by treatment-related AEs and the number of patients who do not necessitate a delay in surgical resection, and to assess overall survival. The secondary objectives are to assess progression free survival, and to assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment

Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Phase Ib/II Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma

Safety and tolerability measured by the incidence of adverse events, serious adverse events and grade 3 or above treatment related adverse events as assessed per CTCAE, Version 5.0.

From start of study treatment until death, loss to follow-up, or withdrawal of consent. Subjects who are lost to survival follow-up will not be replaced, and public records may be accessed to assess Overall Survival.

From start of study treatment until confirmation of disease progression (per iRANO Criteria), intolerable toxicities, withdrawal of consent, or up to 2 years or 18 cycles of pembrolizumab, whichever comes first.

To assess the T cell clonality, CD8 T cell activation and Tumor Infiltrating Lymphocyte (TIL) score after treatment. Blood draws for research purposes performed after obtaining consent but prior to neoadjuvant pembrolizumab administration, and at the time of initiation of SRT and at the time of surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	NCT04743310	Central Nervous...	tozuleristide Canvas imaging ... Surgical resect...	18 Years -	Cedars-Sinai Medical Center
Activated Autologous T Cells Against Glioma Cancer Stem Cell Antigens for Patients With Recurrent Glioblastoma	NCT05341947	Recurrent Gliob...	Activated T cel...	18 Years -	Cedars-Sinai Medical Center
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)	NCT06118723	Glioblastoma High-grade Glio... Glioblastoma, I... Glioblastoma, I... Glioblastoma Mu... Astrocytoma, Gr... Astrocytoma, Gr... Astrocytoma, Ma... Brain Neoplasms Brain Neoplasm,... Brain Neoplasms... Brain Neoplasm,...	Supramaximal re... Maximal safe re...	18 Years - 90 Years	Erasmus Medical Center
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)	NCT06118723	Glioblastoma High-grade Glio... Glioblastoma, I... Glioblastoma, I... Glioblastoma Mu... Astrocytoma, Gr... Astrocytoma, Gr... Astrocytoma, Ma... Brain Neoplasms Brain Neoplasm,... Brain Neoplasms... Brain Neoplasm,...	Supramaximal re... Maximal safe re...	18 Years - 90 Years	Erasmus Medical Center
Fluorescence Detection of Adult Primary Central Nervous System Tumors With Tozuleristide and the Canvas System	NCT04743310	Central Nervous...	tozuleristide Canvas imaging ... Surgical resect...	18 Years -	Cedars-Sinai Medical Center
Trial of Anti-PD-1 Immunotherapy and Stereotactic Radiation in Patients With Recurrent Glioblastoma	NCT04977375	Glioblastoma Mu...	Pembrolizumab Stereotactic Ra... Surgical Resect...	18 Years -	Cedars-Sinai Medical Center

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