Patients with malignant effusions or ascites or advanced cancer
Conditions
Interventions
Use of autologous lymphocytes activated with autologous tumor antigens and dendritic cells
Sponsors
Yamaguchi Yoshiyuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically-defined solid tumors with evaluable lesions, failure or absence of standard therapy 2) Age 20 or more 3) Performance Status (P.S.) 0-2, at outpatient visit basis 4) Estimated prognosis >= 3 months 5) Evaluable organ functions WBC>4,000/mm3, 2,000/mm3 Platelet>100,000/mm3 Hg>10.0g/dl ALT/AST<upper limit x 2 t-Bilirubin<1.5mg/dl Creatinine<1.5mg/dl 6) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Hematologic malignancy, interstitial pneumonia, autoimmune disease 2) Uncontrollable complications including infection, diabetes, hypertension, ischemic heart disease, cerebral infarction, jaundice 3) EGFR-TKI, Immunocheckpoint inhibitors 4) Steroid or immunosuppressive agents 5) No assessable lesions General symptoms including dyspnea, jaundice, edema, effusions, clamp, paralysis, fracture, difficult for out-patient 6) Difficulty to visit hospital (in-patients, oxygen requirement, wheelchair, dementia, edema, effusions, clamp, paralysis, fracture) 7) Active HBV, HCV, HTLV, HIV infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival of each cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival including prior treatments, objective response rate, safety, QOL, biomarkers | — |
Countries
Japan
Contacts
Public ContactTomoyuki Miki
Kawasaki Medical School Hospital
Outcome results
None listed