Vaccination trial to synovial sarcoma patients using HLA-A24 restricted SYT-SSX junction peptide, adjuvant, and HLA-A24 anchor substituted peptide

UMIN ID: UMIN000001359

Registered date:01/10/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: synovial sarcoma
• Date of first enrollment: 2004/03/01
• Target sample size: 6
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Total 6 times, every two weeks vaccination including 1mg of peptide and adjuvant.

Outcome(s)

• Primary Outcome: Toxicity and adverse effect between first vaccination and 2 weeks after 6th vaccination.
• Secondary Outcome: delayed type hypersesitivity, frequency of T lymphocyte responsive to HLA-A24 restricted peptide, cytotoxic T-lymphocyte acitivity, anti-tumor effect

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male and Female
• Exclude criteria: prior chemotherapy, steroid therapy, or other immunotherapy within the past 4 weeks, presence of other cancers, immunodefficiency, history of splenectomy, severe cardiac insufficiency, acute infection, hematopoietic failure , anti-coagulant therapy

Related Information

• Primary Sponsor: Sapporo Medical University
• Secondary Sponsor: Japanese Musculoskeletal Oncology Group
• Source(s) of Monetary Support: Japan Socieity for Promotion of Science