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Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Small Cell Lung Cancer

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Trial Information

Maintenance Immunotherapy With Autologous Cytokine-induced Killer Cells for Small Cell Lung Cancer


Inclusion Criteria:



- Histologically or cytologically proven small cell lung cancer

- Patients currently receiving 4-6 cycles of chemotherapy regimen with VP-16 and a
platinum-based drug as first-line therapy in the absence of disease progression

- Age between 18-75

- Performance status ≤2

- No uncontrolled metabolic disease, infection, and neurological disorders

- No congestive heart failure, severe arrhythmia, and coronal atherosclerosis heart
disease

- Life expectancy more than three months.

- Without contraindication of immunotherapy with autologous cytokine-induced killer
cells

- No other malignancies

- Signed study-specific consent form prior to study entry

Exclusion Criteria:

- Patients receiving other anti-tumor therapy (like thermotherapy)

- Pregnant or lactating women

- Allergy or unacceptable toxicity of immunotherapy with autologous cytokine-induced
killer cells

- Uncontrolled mental disorder

- Patient having acute hepatitis virus infection, active tuberculosis, or other acute
infectious diseases

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Guosheng Feng, MD

Investigator Role:

Study Chair

Investigator Affiliation:

People's Hospital of Guangxi

Authority:

China: Ethics Committee

Study ID:

CIKSCLC-2012

NCT ID:

NCT01592422

Start Date:

July 2012

Completion Date:

September 2015

Related Keywords:

  • Small Cell Lung Cancer
  • Small cell lung cancer
  • Maintenance therapy
  • Immunotherapy
  • Autologous cytokine-induced killer cell
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

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