The pediatric patients who are resistant for standard therapy.
Conditions
Interventions
For the standard therapy-resistant pediatric cancer patients, selected 4 personalized peptide vaccine are administered once a week for 6-8 times.
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) standard therapy resistant cancer patients 2) Patients must be at a sore level of 0-1 of performance status (PS). 3) Patients must be positive for HLA-A2, HLA-A24, or HLA-A3 super type. 4) Patients must have IgG reactive to at least two of peptide of the candidate peptides restricted to the patients HLA types. 5) Patients must satisfy the followings : WBC >and= 2,500mm3 lymphocyte >and= 1,000/mm3 Hb >and= 8.0g/dl platelets >and= 80,000/mm3 serum creatinine <and= 2x upper limit of normal total bilirubin ,and= 2x upper limit of normal 6) Patients must be between 6 and 17 year-old. 7)Patients must be expected to survive more than 3 months. 8) Assent documents for 6-15 year-old patients and written informed consents for 16-17 year-old patients must be obtained. Moreover, informed consents are obtained from their caregivers. 9) Patients must be referred from pediatric cancer specialists.
Exclusion criteria
Exclusion criteria: The following patients must be excluded : 1) Patients with severe symptoms (active and severe infections, circulatory disease, respiratory disease, kidney disease,immunodeficiency, disturbance of coagulation). 2) Active double cancer (synchronous double cancer and meta-chronous double cancer within 3 disease-free years),excluding carcinoma in situ (lesions equal to intra-epithelial or intra-mucosal cancer) judged to have been cured with local treatment. 3) Patients with leukemia 4) Patients with the past history of severe allergic reactions. 5) Patients who hope for pregnancy 6) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 7) Patients who are judged inappropriate for entry to this trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of immune response by measurement of peptide specific IgG before and after peptide vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment (Observation of side effects) Clinical effectiveness(overall survival period) | — |
Countries
Japan
Contacts
Public ContactKeiko Oda
Kurume University Cancer vaccine center
Outcome results
None listed