Pediatric cancer patients
Conditions
Interventions
For the pediatric cancer patients who underlying diseases are controlled and hope for recurrence prevention, we give selected four peptide vaccine once a month for six times.
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pediatric cancer patients (children or adults who are diagnosed as having malignancy when they were under 15-year old) 2) Patients must be at a score level of 0-1 of performance status (PS). 3) Patients must be positive for HLA-A2,HLA-A24, HLA-26, HLA-A3,HLA-A11,HLA-A31,or HLA-A33 super types. 4) Patients must have IgG reactive to at least two of the candidate peptides restricted to the patients HLA types. 5) Patients must satisfy the following : WBC >and= 2,500/mm3 Lymphocytes >and= 900/mm3 Hb >and= 8.0g/dl platelets >and= 80,000/mm3 serum creatinine <and= 2xupper limit of normal total bilirubin <and= 2x upper limit of normal 6) Patients must be between 4 and 30 year-old. 7) Patients must be expected to survive more than 3months. 8) Assent documents for 4-15 year-old patients and written informed consents for more than 16 year-old patients must be obtained.Moreover, informed consents are obtained from their caregivers. 9) Patients must be referred from cancer specialists.
Exclusion criteria
Exclusion criteria: The following patients must be excluded: 1) Patients with severe symptoms (active and severe infections, circulatory diseases, respiratory diseases, kidney diseases, immunodeficiency, disturbance of coagulation). 2) Active double cancer (synchronous double cancer and meta-chronous double cancer within three disease-free years), excluding carcinoma in situ (lesions equal to intra-epithelial or intra-mucosal cancer), judging to have been cured with local treatment. 3) Patients with the past history of severe allergic reactions. 4) Patients who hope for pregnancy 5) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 6) Patients who are judged inappropriate for entry to this trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the recurrence of the original tumor,judgement after six months from the beginning of the peptide vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| assessment of immune response by measurement of peptide specific IgG before and after peptide vaccination | — |
Countries
Japan
Contacts
Public ContactKeiko Oda
Kurume University Cancer vaccine center
Outcome results
None listed