Phase II Clinical trial of personalized peptide vaccine for cancer patients

UMIN ID: UMIN000001482

Registered date:05/11/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: malignant tumor
• Date of first enrollment: 2008/11/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Peptides (maximum 4) among 27 (for HLA-A2, -A24, -A26, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides. Each emulsified peptide (3 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Blood samples for hematology and biochemistry are taken the beginning of vaccination.

Outcome(s)

• Primary Outcome: Evaluation of the peptide specific antibody before and after vaccination.
• Secondary Outcome: Analyze the correlation between enhancemt of peptide specific antibody and all over survival. Adverse events of peptide vaccination are evaluated based on the CTCAE v3.0 (JCOG).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc). 2) Patients with the past history of severe allergic reactions. 3) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 4) Patients who are judged inappropriate for the clinical trial by doctors.

Related Information

• Primary Sponsor: Kurume University Cancer Vaccine Center
• Secondary Sponsor: Sendi public welfare hospital
• Source(s) of Monetary Support: none,The Ministry of Education, Culture, Sports, Science, and Technology, Japan