Autologous Cellular Immunotherapy in Patients With Metastatic Bladder Urothelial Carcinoma

This is an interventional treatment trial for Urinary Bladder Neoplasm focused on measuring Immunotherapy Read More

Inclusion Criteria:

1. Be willing and able to provide written informed consent for the trial.
2. Patients with pathologically and radiographically confirmed metastatic bladder urothelial carcinoma that the efficacy was evaluated as PR or CR after 4 cycles of the standard first-line gemcitabine plus cisplatin
3. 18-75 years old
4. CR or PR confirmed by independent radiological examination.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

6. Adequate hematologic and end-organ function:

   Hemoglobin ≥ 9.0g/dl, Absolute neutrophil count (ANC) > 1,500/mm3, platelets ≥ 50,000/ul Total bilirubin (TBIL) ≤ 2mg/dl, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 the upper limit of normal (ULN) for the institution, Alkaline phosphatase (ALP) ≤ 4 the upper limit of ULN, Prothrombin time (PT) > 50% or prothrombin time-international normalized ratio (PT-INR) < 2.3, Serum creatinine (CREA) ≤ 1.5 the upper limit of ULN.

7. Qualified scanning (CT or MRI) was performed in 4 weeks before the study.

Exclusion Criteria:

1. Patients who were evaluated as stable disease (SD) or progressive disease (PD) after 4 cycles of chemotherapy.
2. Subjects with pathologically bladder urothelial carcinoma of mixed other pathological types such as squamous differentiation or sarcoma are not allowed.
3. Prior radiation therapy to the bladder

4. Significant cardiovascular disease:

   Evidence of NYHA (New York Heart Association) functional class III or IV heart disease.

   Unstable coronary artery disease (CAD) is not allowed, while Myocardial Infarction (MI) 6 months of starting study is allowed.

   Cardiac arrhythmias requiring antiarrhythmic drugs except β-blockers or digoxin are not allowed.

   Uncontrolled hypertension.

5. History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
6. Severe infection (NCI CTCAE Version 3.0 grade > 2).
7. Subjects with epilepsy requiring steroid or antiepileptic drugs.
8. History of allotransplantation.
9. History or any evidence of hemorrhage.
10. Subjects undergoing renal dialysis.
11. Prior or undergoing cancers that primary sites are different from the cancer of this study. Exceptions to this are Cervical carcinoma in situ (CIS), Cured basal cell carcinoma and Cured cancers over 3 years before the study.
12. Ascites that is not controlled by diuretic treatment.
13. History of encephalopathy.
14. Subjects with gastrointestinal hemorrhage in 30 days before the study.
15. Subjects with history of esophageal variceal hemorrhage and it is no effective treatment to prevent the recurrence of hemorrhage.
16. Major surgery was performed in 4 weeks before the study.
17. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
18. Concurrent treatment on another clinical trial or treatment on another clinical trial in 4 weeks before the study.
19. Pregnancy or breast-feeding.
20. There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.
21. Any condition that would interfere with or endanger the safety and compliance of subjects.