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-

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- - A placebo controlled phase III double blind study of ITK-1

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006970

Enrollment

110

Registered

2012-01-04

Start date

2011-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma

Interventions

ITK-1 group : Peptide vaccine (3mg/1.5mL) with selected 2 to 4 are injected subcutaneously once weekly in total 12 times at the first course. At the second to sixteen course, peptide vaccine is admini

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written Informed Consent (If signing in consent form is difficult for the patient due to paralysis, signing by the family in place of the patient in permitted) 2)HLA-A24 positive 3)Showing immune response to 2 or more out of 12 ITK-1 peptides 4)Diagnosed Glioblastoma histopathologically 5)Disease progression confirmed regardless of treated with standard radiotherapy and had received temozolomide 6)Measurable lesions (>=5*5mm) 7)ECOG performance status of 0-2 (3 is acceptable if limited to neural symptoms) 8)Expected to survive more than 3 months 9)Adequate organ function

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactAkira Yamada

Kurume University Research center of Innovative Cancer Therapy

akiymd@med.kurume-u.ac.jp0942-31-7744

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026