Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Oral Cancer

UMIN ID: UMIN000000976

Registered date:10/01/2008

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Advanced or recurrent oral cancer
• Date of first enrollment: 2003/09/01
• Target sample size: 10
• 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: Toxicity
• Secondary Outcome: Clinical and immunological responses. Clinical responses are evaluated by RECIST criteria and change of tumor marker levels. Immunological responses are evaluated by DTH, tetramer staining and ELISPOT assay.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1) prior cancer therapy, such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, 2) presence of other cancers that might influence the prognosis, 3) immunodeficiency or a history of splenectomy, 4) severe cadiac insufficiency, acute infection, or hematopoietic failure, 5) ongoing brest-feeding, 6) unsuitability for the trial based on clinical judgement.

Related Information

• Primary Sponsor: Department of Oral Surgery, 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