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

Inclusion Criteria

• •Informed consent signed
• •21 years or older
• •Histologically confirmed the diagnosis of Grade 4 astrocytic tumour, which includes glioblastoma, giant cell glioblastoma, gliosarcoma, and glioblastoma with oligodendroglial components
• •The availability of histological material for the possibility of revising histological verification
• •IDH 1 Mutation and IDH2 Mutation are not taken into account when enrolling in that study
• •MGMT promoter methylation MUST BE CONFIRMED
• •Must have a Karnofsky performance status of ≥ 70% and the ability to use intranasal administration
• •Sexually active fertile subjects (male and female) must agree to use accepted methods of contraception during the course of the study and for 3 months after the last intranasal administration of Temozolomide
• •Female subjects of childbearing potential must have a negative pregnancy test at screening.
• •Must be capable of understanding and complying with the protocol requirements