Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Astrocytoma of Brain
  • Glioma, Malignant
  • Gliosarcoma
Type
Interventional
Phase
Phase 1
Design
Allocation: RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Parallel AssignmentMasking: Single (Participant)Primary Purpose: Treatment

Participation Requirements

Age
Between 21 years and 70 years
Gender
Both males and females

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 a...

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.

Tracking Information

NCT #
NCT04091503
Collaborators
Not Provided
Investigators
Not Provided