Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers

Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers - Phase I clinical trial of WT1 peptide vaccine therapy for pediatric cancers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011030

Enrollment

Registered

2013-07-01

Start date

2013-07-01

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

Pediatric cancers

Interventions

Seven doses of HLA-A*24- or A*02-restricted WT1 peptide (1-3mg) emulsified with 0.5-2KE of adjuvant will be intradermally injected on bilateral axillary and inguinal areas every 2 weeks. WT1 peptide d

s body weight (1mg of WT1 peptide for body weight (BW) &lt

10kg, 2mg for 10kg &lt

BW &lt

20kg, 3mg for BW &gt

30kg). Injection schedule can be changed within 3 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with pathologically proven pediatric cancers. 2. Patients treated with operation, chemotherapy, and radiotherapy accoding to standard clinical guidelines. 3. Patients who did not received any specific immunotherapy before enrollement of this trial. 4. Patients with HLA-A*02 or A*24 and having neither allergies to OK-432 nor to penicillin. 5. Patients aged 19 years or under at the time of informed concent. 6. Karnofsky performance status (KPS) are over 60%. 7. Estimated survival duration is over 3 months. 8. Function of major organs is maintained, with the following inclusion criteria. A) Leukocyte count>=3,000/mm3 B) Lymphocyte count>=500/ mm3 C) Platelet count>=100,000/mm3 D) Hemoglobin concentration >=10.0g/dL E) AST/ALT <2.5 x ULN F) Serum creatinine <=1.5 x ULN G) APTT/PT-INR <=1.5 x ULN

Exclusion criteria

Exclusion criteria: 1. Patients with severe organ dysfunction, infection under treatment, blood abonormalities or bleeding tendency. 2. Patients with leukemia or lymphoma are excluded.

Design outcomes

Primary

Measure	Time frame
Safety (Ratios of adverse events)	—

Secondary

Measure	Time frame
Overall survival, The ratio of the patients who completed the course, WT1 specific CTL rate in peripheral blood mononuclear cells (PBMCs), Lymphocyte subsets, WT1-specific interferon-gamma production of PBMCs	—

Countries

Japan

Contacts

Public ContactShigetaka Shimodaira

Center for Advanced Cellular Therapy Clinical Trial Research Center

shimodai@shinshu-u.ac.jp0263-37-3220

Outcome results

None listed

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