WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study

WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study - WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013325

Enrollment

Registered

2014-03-04

Start date

2014-10-01

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

rhabdomyosarcoma

Interventions

WT1 peptide-based cancer vaccine weekly intradermal injection WT1 peptide mp235: HLA-A*2402 restricted WT1peptide or np126: HLA-A*0201 restricted WT1peptide Adjuvant Montanide ISA51

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed as rhabdomyosarcoma 2. Metastatic alveolar or embryonal histology or unresectable rabdomyosarcoma group III 3. Performance Status 0-2 4. Under 30 years old 5. HLA-A*2402, A*0201 6. Obtained complete remission or negative on PET-CT 7. WT1 positive 8. Adequate organ function 9. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Active bacterial or fungal infection 2. Severe complications 3. MDS, MDS/MPD, MPD 4. Inadequate physical condition, as diagnosed by the primary physician

Design outcomes

Primary

Measure	Time frame
2 year relapse rate	—

Secondary

Measure	Time frame
2 year progression free rate safety over all survival immunological monitering	—

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