Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma.

Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma. - Phase II clinical trial of WT1 peptide-based vaccine combined with Temozoromide for patients with glioblastoma.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026965

Enrollment

Registered

2017-04-12

Start date

2017-09-01

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

We use three kinds of WT1 peptides. The patient is intradermally injected with the mixture of WT1 peptides emulsified with Montanide ISA51 adjuvant.The WT1 vaccination was scheduled to be started at t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as malignant glioma 2. Informed about his diagnosis 3. WT1 expression in malignant cells 4. Dissemination negative 5. HLA-A*2402 or HLA-A*0201 positive 6. Require no evaluable diaseas 7. Aged 20 and over, and 79 and under 8. Performance Status (ECOG) 0-2 9. Followed by Operation, Radiation and Temozolomide 10. Meet the following criteria for organ functions 1)Neutrophil more than 1,000/microliter, Platelet more than 50,000/microliter, Hemoglobin more than 8g/dl 2) Serum creatinine less than 2.0 mg/dL 3) Serum bilirubin less than 2.0 mg/dL 4) Serum AST/GOT less than 100IU/L 5) Serum Albumin more than 2.5g/dl 6) Arterial oxygen saturation more than 94% in room air 11. Survival period is expected more than 3 months 12. Informed consent has been obtained

Exclusion criteria

Exclusion criteria: 1. There is deep-seated active infection. 2,3 There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial. 4. Dependent on total parenteral nutrition(TPN) 5. There are other malignancies. 6. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD). 7. Post allogeneic hematopoietic stem cell transplantation 8. Pregnant or lactating woman 9. Allergic histry for dacarbazine 10. Responsible doctors judged the patient inappropriate for the trial

Design outcomes

Primary

Measure	Time frame
Progression free survival time	—

Secondary

Measure	Time frame
1) Safety 2) Overall survival time	—

Countries

Japan

Contacts

Public ContactTsuboi Akihiro

Osaka University Graduate School of Medicine Department of Cancer Immunotherapy

tsuboi@cit.med.osaka-u.ac.jp06-6879-3676

Outcome results

None listed

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