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

UMIN ID: UMIN000013325

Registered date:04/03/2014

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: rhabdomyosarcoma
• Date of first enrollment: 2014/10/01
• Target sample size: 33
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 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

Outcome(s)

• Primary Outcome: 2 year relapse rate
• Secondary Outcome: 2 year progression free rate safety over all survival immunological monitering

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 30years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Osaka university graduate school of medicine Pediatrics
• Source(s) of Monetary Support: The Japanese Ministries of Education, Culture, Sports, Science and Technology