Non-invasive bladder cancer
Conditions
Interventions
Patients undergo leukapheresis for the harvest of peripheral blood mononuclear cells (PBMCs). PBMCs are stimulated with 2-methyl-3-butenyl-1-pyrophosphate for 14 days. Patients then receive intravesic
Sponsors
Tokyo Women's Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with cystoscopic diagnosed as bladder cancer who is scheduled transurethral-resection of bladder tumor (TUR-BT). 2) Patients who is able to receive 4 times of intravesical administration of the expanded gamma delta T cells before the TUR-BT. 3) ECOG performance status 0-1 and age > 20-years old. 4) Leukocyte count ≥ 3,000/mm³ ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Serum bilirubin ≤ 1.5 mg/dL AST/ALT ≤ 2.5 times normal Serum creatinine ≤ 1.7 mg/dL LDH ≤ 1.5 times normal PT/APTT/FDP≤ 1.5 times normal 5) 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: 1) No hypercalcemia that require medication, No C-reactive protein with an infectious disease that requires medication, No active infection with hepatitis virus or HIV, No current treatment with steroids and immunosuppressive drugs, 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 2) Other patients judged to be ineligible by the attending investigators were also excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy: Adverts events are accessed by CTCAE ver.4.0. Efficacy is accessed by cystoscopy examination and immunohistochemical staining of the bladder cancer. | — |
Countries
Japan
Contacts
Public ContactHirohito Kobayashi
Tokyo Women's Medical University Department of Urology
Outcome results
None listed