CIK in Treating Patients With Bladder Cancer

Urinary Bladder Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02489890
• Other study ID #: BLAD001
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 24, 2015
• Last updated: February 18, 2016
• Start date: February 2016
• Est. completion date: July 2030

Study information

• Verified date: February 2016
• Source: The First People's Hospital of Changzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: July 2030
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder Neoplasms

Intervention

Biological:
• Cytokine-induced Killer Cells
chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First People's Hospital of Changzhou

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	age	by years	1 week	No
Other	gender	men or women	1 week	No
Other	Performance status	WHO standard	1 week	No
Other	number of sites of extranodal involvement	evaluated by CT scan	1 week	No
Other	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	No
Primary	progression-free survival(PFS)		1 month	No
Secondary	overall survival(OS)		1 month	No