Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma
Status:
Unknown status
Trial end date:
2020-11-15
Target enrollment:
Participant gender:
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