Urotherial cancer
Conditions
Interventions
(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
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.
Sponsors
Kurume University School of medicine, Department of Immunology
The Ministry of Health, Labor and Welfare, Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be diagnosed as urotherial cancer pthologically at the inithial treatment. The patients must be suffering from advanced/metastatic urotherial cancer after M-VAC (methotrexate, vinblastine, doxorubicine and cisplatin) chemotherapy. 2)Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 3)Patients must have IgG reactive to at least one of peptide candidates. 4)When patients had received pre-therapies, including chemotherapy, immunotherapy, and radiation therapy, the vaccine therapy must be started at least more than 4 weeks after the last therapy. Patients showing anti-tumor effects or adverse effects of pre-therapy must be excluded. 5)Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 6)Patients must be expected to survive more than 3 months. 7)Patients must satisfy the followings: WBC >= 3,000/mm3 Hb >= 8.0g/dl Platelet >= 100,000/mm3 Lymphocyte >= 10,000/mm3 Serum Creatinine <= 1.5 mg/dl Total Bilirubin <= 1.5 mg/dl 8)Patients must be negative for Hepatitis virus B/C. 9)Patients must be more 20 year-old and less 85 year-old. 10)Written informed consent must be obtained from patients.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation (clinical responses) of anti-tumor effects of peptide vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
Kurume University School of Medicine Research Center of Innovative Cancer Therapy, Cancer Vaccine Department Division
Outcome results
None listed