Status:
COMPLETED
Evaluate the Safety and Effectiveness of Intranasal Administration of Temozolomide in Patients With Glioblastoma
Lead Sponsor:
Center Trials & Treatment Europe
Conditions:
Glioma, Malignant
Gliosarcoma
Eligibility:
All Genders
21-70 years
Phase:
PHASE1
Brief 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 ...
Detailed 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 impor...
Eligibility Criteria
Inclusion
- 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
Exclusion
- History of hypersensitivity to TMZ or any of its excipients
- The subject has had major surgery within 28 days prior to starting study treatment, or had non-water-tight dural closure during previous surgery, or has unhealed wounds from previous surgery
- The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- The subject is pregnant or breastfeeding
- The subject suffered a stroke according to the results of the first MRI upon admission
- Anti-cancer Agents: Subjects who are currently receiving other anticancer agents are not eligible. Subjects must have fully recovered from the effects of prior chemotherapy (haematological and bone marrow suppression effects), generally at least 3 weeks from the most recent administration (6 weeks for nitrosoureas). Subjects may not have received more than 1 cycle of Irinotecan and Temozolomide as previous relapse therapy
- Subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04091503
Start Date
December 20 2019
End Date
October 28 2022
Last Update
April 25 2023
Active Locations (3)
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1
Central Contact
Banja Luka, Bosnia and Herzegovina, 78000
2
Central Contact
Plovdiv, Bulgaria, 4004
3
Central Contact
Tbilisi, Georgia, 0008