Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma
Summary
The purpose of this pilot study is to determine the safety, tolerability, and the maximum tolerated dose intranasal administration of temozolomide (TMZ) as a single agent in Treatment on the patients with GBM.
Intranasal administration is a new method of treating brain tumours for the direct administration of drugs, inhibitors or viruses, with minimal involvement of the BBB. The investigators know the orally prescribed standard chemotherapy temozolomide (TMZ) is widely used to treat glioma tumours.
Received evidence of safety and efficacy in a full cycle of preclinical trials (on GLP Standart) and tests of calculated doses of intranasal administration of TMZ in healthy volunteers.
Intranasal administration of temozolomide is considered as GBM therapy, which provides direct access to a therapeutic dose of the drug into the brain (to the neoplastic process) with low toxicity
Description
The investigators are trying to evaluate a clinically potentially effective intranasal way of delivering TMZ to the brain, taking into account the anatomical structure of os ethmoidal.
The most important factor in the effectiveness of the drug is the achievement of an adequate amount of the active agent in its unbound state with albumin on the blood of a patient and the exposure time to the tumour process. Failure to comply with this requirement (difficulties in overcoming the BBB) was identified as the main obstacle to the successful treatment of all types of brain tumours. Translation to improved clinical outcomes in a patient with GBM has not yet been realized. The investigators will use modified temozolomide (without changing the chemical formula) to exclude as much as possible Anosmia, Hyposmia and other violation of the identification of odours with participants.
Study Design
Conditions
Glioma, Malignant
Intervention
Intranasal Modified Temozolomide
Location
Central Contact
Banja Luka
Bosnia and Herzegovina
78000
Status
Not yet recruiting
Source
Center Trials & Treatment Europe
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT04091503
- ClinicalTrials.gov processed this data on September 19, 2019
Published on BioPortfolio: 2019-09-20T03:46:39-0400
Clinical Trials
Radiation With Concomitant and Then Sequential Temozolomide in Malignant Glioma
To determine the safety and efficacy of Gliadel 3.85% wafers plus surgery and radiation with Temozolomide
Temozolomide in Treating Patients With Recurrent Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide ...
Temozolomide in Treating Patients With Recurrent or Progressive Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of temozolomide ...
Phase I Study of Safety and Tolerability of Acetazolamide With Temozolomide
We hypothesize that ACZ can be safely administered concomitantly with TMZ in patients with malignant glioma and that this regimen improves patient survival without increasing toxicity to a...
Temozolomide in Treating Patients With Recurrent Glioblastoma Multiforme or Other Malignant Glioma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPO...
PubMed Articles
Effects of Far-infrared Ray on Temozolomide-treated Glioma in Rats.
Malignant glioma is a rapidly progressive primary brain cancer. The aim of the study was to investigate the effect of far-infrared ray (FIR) on temozolomide (TMZ)-treated glioma in rats.
Glioma is one of the most lethal malignancies and molecular regulators driving gliomagenesis are incompletely understood. Although temozolomide (TMZ) has been applied for malignant gliomas as a canoni...
Malignant Transformation of Molecularly Classified Adult Low Grade Glioma.
Malignant transformation (MT) of adult grade II glioma (low-grade glioma [LGG]) is associated with adverse survival. We sought to describe the incidence, outcomes, and risk-factors for MT of molecular...
Dysregulation of numerous lncRNAs has been recently confirmed in glioma; however, the majority of their roles and mechanisms involved in this notorious disease remain largely unclear. This study aims ...
Glioma is the most common primary malignant tumor in the central nervous system. Because of the resistance of glioma to chemoradiotherapy and its aggressive growth, the survival rate of patients with ...
Medical and Biotech [MESH] Definitions
Pontine Glioma
A malignant BRAINSTEM neoplasm of the PONS. They are more commonly found in children than adults.
Food, Genetically Modified
Food derived from genetically modified organisms (ORGANISMS, GENETICALLY MODIFIED).
Administration, Intranasal
The administration of drugs through the nasal passage.
Pleural Effusion, Malignant
Presence of fluid in the PLEURAL CAVITY as a complication of malignant disease. Malignant pleural effusions often contain actual malignant cells.
Optic Nerve Neoplasms
Benign and malignant neoplasms that arise from the optic nerve or its sheath. OPTIC NERVE GLIOMA is the most common histologic type. Optic nerve neoplasms tend to cause unilateral visual loss and an afferent pupillary defect and may spread via neural pathways to the brain.
More From BioPortfolio on "Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma"
Quick Links
Advanced Search |
Login |
Subscribe |
RSS 
BioPortfolio Twitter Channels (200+ Accounts)
LinkedIn