A placebo controlled phase III double blind study of ITK-1 -The efficacy and safety evaluation of ITK-1 in Temozolomide refractory Glioblastoma patients with HLA-A24 positive
Phase 3
- Conditions
- Glioblastoma
- Registration Number
- JPRN-UMIN000006970
- Lead Sponsor
- Kurume University Cancer Vaccine Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
1)Infratentorial tumor, gliomatosis cerebri, meningeal dissemination 2)Hypersensitivity to mineral oil or mannitol oleate or contrast medium for MRI 3)Severe complications 4)Active multiple cancers 5)Received ITK-1 in the m for MRI past 6)Entry to the other clinical trial within 2 months prior to entry to this study 7)Difficult to participate in this trial because of psychiatric symptoms 8)Pregnant or breast-feeding patients 9)Any other cases who are judged as being ineligible for this study by physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method 1. Survival rate at 12 months 2. Objective tumor response 3. Objective tumor response(Macdonald's Criteria) 4. Progression-free survival 5. 6-month progression-free survival 6. Anti-peptide antibody titer 7. Cytotoxic T lymphocyte activity 8. Frequency of adverse reactions and adverse events