Immunotherapy Using HLA-A24-restricted Survivin-derived Peptide for Patients with Colorectal Cancer and Breast Cancer

UMIN ID: UMIN000000902

Registered date:23/11/2007

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: Advanced or recurrent colorectal cancer and breast cancer
• Date of first enrollment: 2003/03/01
• Target sample size: 30
• 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
Survivin-2B peptide vaccination at a dose of 10mg 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 and change of tumor marker levels.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: Exclusion criteria included (1) the presence of other cancers that might influence the prognosis, (2) immunodeficiency or a history of splenectomy, (3) need of steroid therapy, (4) severe cardiac insufficiency, acute infection, or hematopoietic failure, (5) prior cancer therapy such as chemotherapy, radiation therapy, steroid therapy, or other immunotherapy within the past 4 weeks, (6) ongoing breast-feeding, and (7) unsuitability for the trial based on clinical judgment.

Related Information

• Primary Sponsor: Department of 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