breast cancer
Conditions
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must be satisfactory the following conditions. 1 patients must be diagnosed as breast cancer. The patients must be suffering from cervical cancer after the standard therapy. 2 patients must be positive for HLA-A2,A24,A26 or A3 supertype. 3 patients must have immunoglobulin g reactive to at least two of candidate peptides. 4 patients must be at a score level 0-1 of performance status. 5 patients must be expected to survive more than 3 months. 6 Patients must satisfy the followings WBC is more than 2500 per mm3 Lymphocyte is more than 1000 per mm3 Hb is more than 8 g per dl Platelet is more than 80000 per mm3 Serum creatinine is less than 2 times upper limit of normal Total bilirubin is less than 2 times upper limmit of normal 7 patients must be more 20 year old. 8 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 the past history of severe allergic reactions. 3. Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination. 4. Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of immunological responses (anti-peptide IgG) before and after peptide vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of long-term prognosis (progression free survival and total survival). 2. Adverse effects of peptide vaccination with estramustine / safety of the protocol is evaluated based on the NCI-CTC. | — |
Countries
Japan
Contacts
Public ContactAkira Yamada
kurume university Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Outcome results
None listed