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Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma.

Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma. - Phase I clinical trial of WT1 peptide-based vaccine combined with Temozoromide for pediatric patients with malignant glioma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000013257
Enrollment
18
Registered
2014-02-26
Start date
2014-07-01
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

High grade glioma, Diffuse intrinsic pontine glioma

Interventions

The patient is intradermally injected with 0.5-2.0 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN), HLA-A*0201-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMN

Sponsors

Osaka University Graduate School of Medicine Pediatrics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as malignant glioma or diffuse intrinsic glioma 2. Performance status (ECOG) 0-3 3. Meet the following criteria for organ functions Neutrophil more than 1,000/microliter, Platelet more than 25,000/microliter, Hemoglobin more than 6.5 g/dl Serum creatinine less than 2.0 mg/dL Serum bilirubin less than 3 folds of the upper normal limit Serum AST/GOT less than 3 folds of the upper normal limit Serum Albumin more than 2.5g/dl Arterial oxygen saturation more than 94% in room air 4. Informed consent has been obtained from legal guardian. 5. HLA 2402 and or 0201 6. WT1 expression in malignant cells in high grade glioma

Exclusion criteria

Exclusion criteria: 1. There is deep-seated active infection. 2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis. 3. Patients who have complications that are considered inappropriate for the trial. 4. There are other malignancies. 5. There are hematopoietic stem cell disorders such as MDS. 6. Post allogeneic hematopoietic stem cell transplantation 7. Responsible doctors judged the patient inappropriate for the trial

Design outcomes

Primary

MeasureTime frame
Safty

Secondary

MeasureTime frame
progression free survival time all over survival time Immunomonitering

Countries

Japan

Contacts

Public ContactYoshiko Hashii

Osaka University Graduate School of Medicine Pediatrics

areken@ped.med.osaka-u.ac.jp06-6879-3932

Outcome results

None listed

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