CIK in Treating Patients With Bladder Cancer

A Randomized Controlled Study of Cytokine-induced Killer Cells (CIK) Treatment in Patients With Staging Ⅰ-Ⅲ of Urinary Bladder Carcinoma

Chemotherapy is the main treatment method for patients with Bladder Cancer. However, Relapse remains the major cause of treatment failure.Biological therapies such as CIK stimulate the immune system and stop tumor cells from growing. A series of studies reported that cytokine-induced killer cells (CIK) have a broad anti-tumor spectrum. The investigators suppose that CIK will improve the prognosis. Combining chemotherapy with biological therapy may kill more tumor cells. In this study, the patients will be treated with CIK cells after chemotherapy. The purpose of this study is to evaluate the efficacy of CIK for Bladder Cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Urinary Bladder Neoplasms
• Intervention / Treatment: Biological: Cytokine-induced Killer Cells

Detailed Description

About 1500 patients with staging I-III of Bladder Cancer, after accepting chemotherapy, will be randomly divided into group A (receive CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 3 cycles of CIK cells treatment (every 12 weeks). Patients in group B will have no anti-tumor therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 1500
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients histologically confirmed carcinoma in of the bladder with urinary cytology;
• Patients with staging I-III of Bladder Cancer;
• Patients who had completed chemotherapy;
• Patients who have a life expectancy of at least 12 weeks;
• Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
• The bone marrow functioned normally (WBC>4.0×10^9/L, Hb>120 g/L, Platelet(PLT)>100×10^9/L);
• The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

• Patients who had upper urinary tract disease (e.g., vesico-ureteral reflux or massive stones) that would make multiple transurethral procedures risk;
• Patients who had urethral strictures that would prevent endoscopic procedures and repeated catheterization;
• Patients who had prior or concurrent upper urinary tract tumors;
• Patients who had distant metastases by imaging studies;
• Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
• Patients who were lactating;
• ECOG perform status ≥ 2;
• Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment;
• Patients who are pregnant or nursing;
• Patients with active tuberculosis (highly positive skin tests allowed if no active disease);
• Patients with disease that would preclude general anesthesia;
• Patients with active intractable or uncontrollable infection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Non-CIK; After accepting chemotherapy, patients will regularly follow up.
Experimental: CIK; After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year.	Biological: Cytokine-induced Killer Cells; chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment; Other Names: CIK

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
progression-free survival(PFS)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival(OS)	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
age	by years	1 week
gender	men or women	1 week
Performance status	WHO standard	1 week
number of sites of extranodal involvement	evaluated by CT scan	1 week
Stage at diagnosis	Tumor Node Metastasis (TNM) stage, Tumor:CIS,T1,T2,T3,T4 according to the depth of tumor invasion. Lymph node involvement: N0,N1,N2. Metastasis: M0,M1	1 week

Collaborators and Investigators

• Sponsor: The First People's Hospital of Changzhou

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2030

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 3, 2015

Study Record Updates

• Last Update Posted (Estimate): February 22, 2016
• Last Update Submitted That Met QC Criteria: February 18, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: BLAD001