sarcoma
Conditions
Interventions
Select vaccine peptide(Up to 4)from 31 candidate peptides, to whichi peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with adjuvant and subcutaneously injec
Sponsors
Kurume University Cancer Vaccine Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subjects must satisfy the following conditions. 1)Patients must be diagnosed as advanced sarcoma. 2)Patients must have evaluative lesion on imaging 3)Patients must be at a score level 0 or 1 of ECOG performance status. 4)Patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 5)Patients must be expected to survive more than 3 months. 6)Patients must satisfy the followings: WBC is more than 2500/mm3 Lymphocytes is more than 900/mm3 Hb is more than 8.0g/dL Platelet is more than 50000/mm3 Serum Creatinine is less than 2.0mg/dL Serum Total Bilirubin is less than 2.5mg/dL 7)Patients must be more than 18 years old 8)Written informed concent must be obtained from patients. 9)Parients must be positive for HLA-A2,A24,A26,A3,A11,A31 or A33
Exclusion criteria
Exclusion criteria: The following patients must be excluded. 1)Patients with sereve symptoms(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disease of coagulation and so on.) 2)Patients with the past history of severe allergic reactions. 3)(Females) Patients who are during pregnancy, lactation expectant and desiring future fertility. (Males) Patients do not accept contraception during the 1st vaccination to 70 days after last vaccination. 4)Patient who have active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years),excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 5)Patients who are judged inappropriate for the clinical trial by doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical effect(Overallsurvival,Progression free time) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safty,Immunoresponse | — |
Countries
Japan
Contacts
Public ContactShigeru Yutani
Kurume University Cancer Vaccine Center
Outcome results
None listed