Neoplasms

All Conditions

Nervous System Diseases

Musculoskeletal Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Glioblastoma

Glioma

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Brain Neoplasms

Central Nervous System Neoplasms

Medulloblastoma

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Nervous System Neoplasms

Spinal Cord Neoplasms

Pinealoma

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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

BLZ-100

Sarah Leary, MD, MS

Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have spread from the original tumor site, resulting in incomplete removal of the tumor and reduced patient survival. In some sites, such as the brain, it is critical to avoid damage to normal tissue around the tumor to prevent adverse effects of surgery on function. The investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as they operate. This is a safety study to assess the safety of BLZ-100 in pediatric patients with central nervous system tumors.

Subjects who provide voluntary written informed consent, or have it provided by their legally acceptable representative, will be screened for eligibility. Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to participate.

Subjects will be required to arrive at the hospital for dosing at least 1 hour before the planned surgical excision. Following dosing, subjects will be monitored for safety and surgical excision will occur at least 1 hour after study product administration.

Study of BLZ-100 in Pediatric Subjects With CNS Tumors

A Phase 1 Dose-escalation and Expansion Study of BLZ-100 in Pediatric Subjects With Primary Central Nervous System Tumors

Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.

BLZ-100 levels in blood will be analyzed by chemical means and these data will be used to calculate pharmacokinetic parameters.

Fluorescence signal in sections of excised tumor and adjacent normal tissue will be measured using an infrared imaging system.

For subjects enrolled in the expansion cohort, an extent of resection assessment will be made by the surgeon and confirmed by post-operative MRI according to standard of care procedures.

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Mouth Neoplasms

Squamous Cell Carcinoma of Head and Neck

Lip Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Oral Cancer

Lip and Oral Cavity Cancer

Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.

Near Infrared Imaging

Therapeutic Conventional Surgery

Tozuleristide

Emily Marchiano

This phase I/II trial studies the side effects of tozuleristide in imaging oral cavity squamous cell cancer and high-grade oral cavity dysplasia during surgery. Tozuleristide is an imaging agent that specifically binds to tumor cells. When exposed to near-infrared light, tozuleristide causes tumor cells to fluoresce (light up), so that surgeons may better distinguish tumor cells from healthy cells during surgery.

OUTLINE:

Beginning 1 hour before surgery, patients receive tozuleristide intravenously (IV) over 1-5 minutes. Patients then surgical resection per standard of care and undergo near infrared (NIR) imaging with standard of care device.

A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery

Intraoperative Visualization of Oral Cavity Squamous Cell Carcinoma and High-Grade Dysplasia With Tozuleristide, a Fluorescent Tumor Marking Agent

Adverse events will be summarized as the number and percentage of patients with each type of adverse event, per Criteria for Adverse Events version 5.0.

Will be estimated by a repeated measure logistic regression modeling the probability of positive tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A general estimating equation (GEE) method will be used to estimate the regression parameters.

Will be estimated by a repeated measure logistic regression modeling the probability of negative tumor. The model includes an exchangeable working correlation structure to account for potential correlations of biopsies within subject for the tumor-positive tissue biopsies. A GEE method will be used to estimate the regression parameters. The repeated measures logistic regression will model the probability of tumor-negative biopsies.

To investigate the accuracy of tozuleristide fluorescent imaging in identifying tumor and achieving negative margins during excision of oral cavity squamous cell carcinoma and high-grade dysplasia.

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
Study of BLZ-100 in Pediatric Subjects With CNS Tumors	NCT02462629	Central Nervous...	BLZ-100	1 Month - 30 Years	Blaze Bioscience Inc.
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
Study of BLZ-100 in Pediatric Subjects With CNS Tumors	NCT02462629	Central Nervous...	BLZ-100	1 Month - 30 Years	Blaze Bioscience Inc.
A Fluorescent Tumor Marking Agent, Tozuleristide, for Imaging Oral Cavity Squamous Cell Cancer and High-Grade Oral Cavity Dysplasia During Surgery	NCT05316688	Oral Cavity Squ... Stage I Lip and... Stage II Lip an... Stage III Lip a... Stage IVA Lip a...	Near Infrared I... Therapeutic Con... Tozuleristide	18 Years -	University of Washington

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