Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Rare Diseases

Recurrence

Glioma

Glioblastoma

Astrocytoma

Central Nervous System Neoplasms

Nervous System Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neuroepithelioma

Amino Acids

All Drugs and Chemicals

Tyrosine

Maximilian Niyazi, MD, MSc

Patients with recurrent glioblastoma who are planned to receive a second course of radiation are to be included into this monocentric cohort trial. Due to multiple pre-treatments simultaneous combined positron emission tomography (PET) with O-(2-\[18F\]fluoroethyl)-l-tyrosine (FET) as well as magnetic resonance imaging (MRI) is used for treatment planning and follow-up imaging as it allows for a better distinction between treatment-related changes and viable tumor tissue.

For glioblastoma (GBM) patients it has been proven that a \[18F\]FET-PET scan is very helpful especially in target volume definition and after the treatment, in turn, the combination of MRI and \[18F\]FET-PET is diagnostically most useful to distinguish between radiation necrosis and a real progressive disease.

The response to therapy is based on the newly formulated Revised Assessment in Neuro-Oncology (RANO) criteria. Kinetic and static \[18F\]FET-PET scans are useful to supplement this modality and its own prognostic value concerning relapsing patients will be examined.

The special feature of this study is the use of both modalities in parallel, allowing simultaneous acquisition of morphological changes, functional and molecular imaging.

Secondary methodological issues are dealt with, such as the relationship between contrast uptake, perfusion and \[18F\]FET uptake. In this regard, the hybrid imaging may serve for hypothesis generation, as in parallel in a unique way of contrast enhancement and tracer kinetics can be investigated (simultaneous contrast-enhanced analysis and tracer application).

In particular, FET kinetics are examined in more detail (for example, differences between increasing and decreasing kinetics) to find ways of how to use certain MRI sequences for better visualization of viable tumor tissue and vice versa .

Combined O-(2-[18F]Fluoroethyl)-L-tyrosine (FET) Positron Emission Tomography (PET) and Simultaneous Magnetic Resonance Imaging (MRI) Follow-up in Re-irradiated Recurrent Glioblastoma Patients

Untersuchungen Zur Verlaufskontrolle Bei Re-Bestrahlung Von Glioblastompatienten Mittels Kombinierter [18F]FET-PET-Kernspintomographie

Ludwig-Maximilians - University of Munich

Principal Investigator

Disease Attributes

Oligodendroglioma

Vorasidenib

Servier Pharmaceuticals LLC

Jonathan Dewey, MD

This is an expanded access program to provide vorasidenib for treatment of patients 12 years or older with IDH1- or IDH2-mutated glioma.

This expanded access program is designed to provide access to vorasidenib for patients with IDH1- or IDH2-mutated glioma who are not eligible for other vorasidenib clinical trials, and who in the opinion of the treating oncologist would potentially benefit from treatment with vorasidenib.

Safety assessments (including vital signs, hematology, and serum chemistry) occur every two weeks for the first two cycles (28 day each cycle), then monthly for the duration of treatment. Treatment with vorasidenib will continue until, in the clinical judgement of the treating physician, the patient is no longer benefiting from the treatment, vorasidenib is approved and available by prescription, or the study is terminated.

Requests by treating physicians to file a single patient investigational new drug application as part of the expanded access program for vorasidenib will be considered on a case-by-case basis.

Vorasidenib Expanded Access Program

The Expanded Access Use of Vorasidenib in Patients With IDH1 or IDH2 Mutated Glioma

Servier Pharmaceuticals, LLC

Servier

Skin and Connective Tissue Diseases

Brain Neoplasms

Dermatitis, Phototoxic

Neoplasm, Residual

Dermatitis

Brain Diseases

Central Nervous System Diseases

Dermatitis, Irritant

Dermatitis, Contact

Skin Diseases

Photosensitivity Disorders

Skin Diseases, Eczematous

Neoplastic Processes

Central Nervous System Depressants

Pharmaceutical Solutions

Dermatologic Agents

Anesthetics

Aminolevulinic Acid

Photosensitizing Agents

Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

5-Aminolevulinic Acid (5-ALA) Gliolan®

During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.

Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

Alberto Valarezo Chuchuca, MD

The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

Overall survival is defined as time from initiation to death of any cause

The questionnaire provides an additional set of disease-specific questions pertaining to brain neoplasms. It consists of 46 items that refer to general issues of quality of life and specific to tumor location. Possible scores range from 0 to 108, with higher scores indicating better quality of life.

The average length of stay in hospitals is often used as an indicator of efficiency. The ALOS refers to the average number of days that patients spend in hospital after surgery. It is calculated by dividing the number of bed-days by the number of discharges after procedure. Average length of stay range from 1 day to 4.5 days. Longer than average stays are usually a symptom of poor communication, quality of care, and effectiveness of treatment.

Sociedad de Lucha Contra el Cáncer del Ecuador

Infections

Adenoviridae Infections

Gliosarcoma

Anti-Infective Agents

Antineoplastic Agents

Immunomodulating Agents

Interferons

Interferon-gamma

Antiviral Agents

Single intratumoral injection of DNX-2401

Interferon gamma (IFN-γ) beginning at Day 14

In the randomized group, following brain tumor biopsy and histological confirmation of recurrent glioblastoma/gliosarcoma, a single injection of DNX-2401 was administered directly into the brain tumor with or without subsequent interferon gamma (IFN-γ)

No additional subjects will be randomized. A single intratumoral dose of DNX-2401 will be delivered by cannula.

In the randomized group, a single injection of DNX-2401 was followed by interferon gamma (IFN-γ). No additional subjects will be randomized or receive IFN-γ following DNX-2401

Nam Tran, MD, PhD

Karen Fink, MD, PhD

Vinay Puduvalli, MBBS

Frederick Lang, MD

Glioblastoma (GBM) and gliosarcoma (GS) are the most common and aggressive forms of malignant primary brain tumor in adults and can be resistant to conventional therapies. The purpose of this Phase Ib study is to evaluate how well a recurrent glioblastoma or gliosarcoma tumor responds to one injection of DNX-2401, a genetically modified, conditionally replicative and oncolytic human-derived adenovirus. DNX-2401 is delivered directly into the tumor where it may establish an active infection by replicating in and killing tumor cells.

Enrollment has been completed for the randomized portion of the study with ongoing evaluation of tumor response and safety. No additional subjects will be randomized or receive interferon gamma (IFN-γ).

The non-randomized portion of the study is open for screening and enrollment. Eligible subjects will receive a single intratumoral injection of DNX-2401 into a recurrent glioblastoma or gliosarcoma brain tumor using the Alcyone MEMS Cannula (AMC™) System (cannula). Tumor response and safety will be evaluated.

After receiving DNX-2401, subjects will return to the clinic for study visits at regular intervals for safety monitoring, MRI scans and other assessments for up to 18 months. Thereafter, they will be followed closely for safety and survival.

DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors

A Phase 1b, Randomized, Multi-center, Open-label Study of a Conditionally Replicative Adenovirus (DNX-2401) and Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma (TARGET-I)

Interval tumor size change will be measured

Events are classified using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

Laboratory test results and other assessments will be utilized to determine effects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined O-(2-[18F]Fluoroethyl)-L-tyrosine (FET) Positron Emission Tomography (PET) and Simultaneous Magnetic Resonance Imaging (MRI) Follow-up in Re-irradiated Recurrent Glioblastoma Patients	NCT01579253	Glioblastoma Nervous System ... Central Nervous... Astrocytoma Glioma Neoplasms, Neur... Neuroectodermal... Neoplasms by Hi... Neoplasms, Nerv...		18 Years - 75 Years	Ludwig-Maximilians - University of Munich
Vorasidenib Expanded Access Program	NCT05592743	Glioma Recurrence Disease Attribu... Pathologic Proc... Neoplasms, Neur... Neuroectodermal... Neoplasms, Germ... Neoplasms by Hi... Neoplasms Neoplasms, Glan... Neoplasms, Nerv...	Vorasidenib	12 Years -	Servier
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas	NCT05850377	High Grade Glio... Glioma Glioma, Maligna... Neoplasms, Neur... Neuroectodermal... Photosensitizin... Neoplasm Malign... Brain Neoplasms... Central Nervous... Brain Tumor Tumour, Residua...	5-Aminolevulini... Fluorescence-Gu...	18 Years - 75 Years	Sociedad de Lucha Contra el Cáncer del Ecuador
DNX-2401 With Interferon Gamma (IFN-γ) for Recurrent Glioblastoma or Gliosarcoma Brain Tumors	NCT02197169	Glioblastoma or...	Single intratum... Interferon-gamm...	18 Years -	DNAtrix, Inc.
Vorasidenib Expanded Access Program	NCT05592743	Glioma Recurrence Disease Attribu... Pathologic Proc... Neoplasms, Neur... Neuroectodermal... Neoplasms, Germ... Neoplasms by Hi... Neoplasms Neoplasms, Glan... Neoplasms, Nerv...	Vorasidenib	12 Years -	Servier

Spots Global Cancer Trial Database for neoplasms, neuroepithelial