Glioblastoma
Conditions
Interventions
investigational material(s)
Generic name etc : ITK-1
INN of investigational material : ITK-1
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materi
Sponsors
Kurume University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Acquisition of consent of participating in clinical trial participation (However, if signature of the subject himself / herself is difficult due to neurologic symptoms, the author may confirm the consent of the subject himself / herself) 2)HLA-A24 positive 3)Antibody reacts to two or more of 12 types of ITK-1 peptides 4)Diagnosis of glioblastoma by histopathological examination 5)Relapse or re-increase after standard treatment (radiotherapy and temozolomide) treatment 6)Measurable lesion (lesion with two longest diameters in the vertical direction of 5 mm or more each) 7)Performance status (PS, ECOG) 0 to 2 (PS3 with nerve symptoms only is possible) 8)Investigational responsibility (shared) Doctors judge that life expectancy of 12 weeks or more can be expected from the time of book registration 9)Laboratory test values satisfy the following criteria White blood cell count > 3,000 / mm 3 Hemoglobin amount > 8.0 g / dL Platelet count > 75,000 / mm 3 Serum creatinine < twice the facility reference upper limit Total bilirubin < 1.5 times the facility reference upper limit AST, ALT < 2.5 times the facility reference upper limit
Exclusion criteria
Exclusion criteria: 1) Undertent tumor, cerebral gliomatosis, meningeal dissemination 2) Mineral oil, mannitol oleate, hypersensitivity to MRI contrast medium 3) Serious complications 4) Overlapping Cancer During Treatment 5) In the past administered ITK-1 6) Participate in other clinical trials within 2 months of starting the trial 7) lacking ability to agree on mental symptoms 8) Pregnant women, lactating women and pregnancy wish 9) Other investigational responsibilities (shared) Doctors deem it inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety Overall survival Comparison between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety 1. 12-month survival rate 2. Tumor shrinkage effect 3. Overall anti-tumor effect 4. progression-free survival 5. 6 months progression-free survival 6, anti-peptide antibody titer 7. Cytotoxic T cell activity 8. Frequency of occurrence of side effects and adverse event frequency Comparison between groups | — |
Countries
Japan
Outcome results
None listed