CIK in Treating Patients With Bladder Cancer

NCT02489890 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: BLAD001
• Study Type: interventional
• Target: 1,500
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Urinary Bladder Neoplasms

Outcome Measures

Primary Outcomes (1)

• progression-free survival(PFS)

  1 month

Secondary Outcomes (1)

• overall survival(OS)

  1 month

Other Outcomes (5)

• age

  1 week

• gender

  1 week

• Performance status

  1 week

Study Arms (2)

Non-CIK

NO INTERVENTION

After accepting chemotherapy, patients will regularly follow up.

CIK

EXPERIMENTAL

After accepting chemotherapy, patients will receive at least 3 cycles of Cytokine-induced Killer Cells treatment per year.

Biological: Cytokine-induced Killer Cells

Interventions

Cytokine-induced Killer Cells BIOLOGICAL

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

Also known as: CIK

CIK

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 3, 2015
• Study Start: February 1, 2016
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 22, 2016

Record last verified: 2016-02