advanced Renal cell carcinoma
Conditions
Interventions
Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate and aldesleukin for 11 to 14 days. Patients t
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with Stage IV (any T, any N, M1) or local advanced or inoperative RCC 2)Patients who received standard therapy resulted in failure or were not acceptability to molecular target drugs 3)ECOG performance status 0-1 4)Age over 20-years old. 5)Leukocyte count; 2,000/uL; ANC ; 1,200/uL; Platelet count; 70,000/uL; Serum bilirubin; 1.5 mg/dL AST/ALT; 2.5 times normal Serum creatinine; 1.7 mg/dL (exceptunder hemodialysis) LDH; 1.5 times normal PT/APTT/FDP;1.5 times the facilities standard value 8) Patients who voluntarily provided written consent to participate in this trial after having been thoroughly briefed and informed of its nature were eligible for enrollment.
Exclusion criteria
Exclusion criteria: No C-reactive protein with an infectious disease that requires medication, No active infection with hepatitis virus or HIV, No poorly controlled DM or heart failure or arrhythmia, No autoimmune disease and interstitial pneumonia, No other malignancy, No bone of organ transplant recipient, Not pregnant nor nursing, No mental disorder in spite of standard therapy 3) Other patients judged to be ineligible by the attending investigators were also excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the factors of effective cases To analyze the factors of the patients who achieved CR, PR or SD by RECIST criteria | — |
Countries
Japan
Contacts
Public ContactHirohito Kobayashi
Tokyo Women's Medical University Department of Urology
Outcome results
None listed