Phase II clinical trial of personalized peptide vaccination in patients with advanced/metastatic urotherial cancer previously treated with M-VAC chemotherapy

UMIN ID: UMIN000001061

Registered date:10/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Urotherial cancer
• Date of first enrollment: 2008/03/01
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): (1st treatment:total 12 times, every week) Day 1: Select peptide candidates (up to 4), to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide). Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78: Inject subcutaneously the same peptides as those of the 1st injection at the same dose. Day 85: Final evaluation. The 1st treatment (total 12 times, every week) is finished, but the 2nd treatment would be continued according to the patient's request. The schedule will be determined based on the reactivity to peptides. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be changed.

Outcome(s)

• Primary Outcome: Evaluation (clinical responses) of anti-tumor effects of peptide vaccination.
• Secondary Outcome: 1.Evaluation of immunological responses (cytotoxic T lymphocytes (CTL), CTL precursors, anti-peptide IgG) before and after peptide vaccination. 2.Subjective effects (pain due to metastatic lesion, symptoms based on urinary disturbance due to primary lesion, PS, progression of cancer / change of body weight according to improvement) and evaluation of quality of life based on FACT examination sheet. Evaluation of long-term prognosis (progression free survival and total survival). 3.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• 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). 2) Patients with multiple cancers 3) Patients with the past history of severe allergic reactions. Patients who are judged inappropriate for the clinical trial by doctors.

Related Information

• Primary Sponsor: Kurume University School of medicine, Department of Immunology
• Secondary Sponsor: The Ministry of Health, Labor and Welfare, Japan
• Source(s) of Monetary Support: The Ministry of Education, Culture, Sports, Science, and Technology, Japan