Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma

PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

December 20, 2019

Primary Completion Date

September 21, 2022

Study Completion Date

October 28, 2022

Conditions
Glioma, MalignantGliosarcomaAstrocytoma of Brain
Interventions
DRUG

Intranasal Modified Temozolomide

"Intranasally Modified Temozolomide is administered to patients at a dose of 75/150/200 mg / M2 for five days continuously. After the 5-day course, patients do not take treatment for two days, and they will be examined on an outpatient basis (blood tests, kidney and liver tests, visually mucous membranes of the mouth, nasal cavity, olfactory rapid tests, including the University of Pennsylvania test, etc.).~After 30 days after the first intranasal administration of Modified Temozolomide (IM-TMZ), all patients undergo an MRI of the brain with perfusion and ultrasound of the abdominal cavity as an outpatient, after which the results are evaluated"

Trial Locations (3)

4004

Central Contact, Plovdiv

78000

Central Contact, Banja Luka

0008

Central Contact, Tbilisi

All Listed Sponsors
lead

Center Trials & Treatment Europe

NETWORK

NCT04091503 - Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma | Biotech Hunter | Biotech Hunter