Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Urothelial Cancer (Phase I clinical study)

UMIN ID: UMIN000001499

Registered date:11/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced or recurrent urothelial cancer
• Date of first enrollment: 2004/11/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Survivin-2B peptide vaccination at a dose of 0.1mg every 2 weeks
Survivin-2B peptide vaccination at a dose of 1.0mg every 2 weeks

Outcome(s)

• Primary Outcome: Evaluation of adverse effect
• Secondary Outcome: Evaluation of immunological and clinical responses. Immunological responses are investigated by DTH, tetramer staining, and ELISPOT assay. Clinical responses are evaluated by RECIST criteria.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria included (1) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the previous 4 weeks, (2) the presence of other cancers that might influence the prognosis, (3) immunodeficiency or a history of splenectomy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure and (5) unsuitability for the trial based on clinical judgment.

Related Information

• Primary Sponsor: Department of Urology, Sapporo Medical University School of Medicine
• Secondary Sponsor: Department of Pathology, Sapporo Medical University School of Medicine
• Source(s) of Monetary Support: Japan Science and Technology Corporation Innovation Plaza Hokkaido, Sapporo, Japan