WT1 peptide vaccination for pediatric patients: phase I/II study.

UMIN ID: UMIN000013252

Registered date:25/02/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pediatric malignant tumor, hematological malignancy
• Date of first enrollment: 2006/04/24
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The patient is intradermally injected with 0.5-3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination is scheduled to be performed 12 times at weekly intervals( phase 1). The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria after 12th WT1 vaccination (phase 2). If no SAE, the vaccination is continued bi-weekly or monthly.

Outcome(s)

• Primary Outcome: The frequency of side effect. The effectivness
• Secondary Outcome: WT1specific immunological reaction

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 20years-old
• Gender: Male and Female
• Exclude criteria: 1) active infectious diseases 2) Severe Complications, including Heart failure, Renal faiure, Hapatic failure, ileus, uncontrolable DM, and so on 3) Other severe problems unsuitable for this study active infectious diseases

Related Information

• Primary Sponsor: Osaka University Graduate School of Medicine
• Source(s) of Monetary Support: Grant-in-Aid from the Ministry of Education, Science and Culture of Japan