Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00103116
Recruitment Status : Completed
First Posted : February 8, 2005
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Hirschowitz, University of Kentucky

February 7, 2005
February 8, 2005
November 7, 2013
April 4, 2017
April 4, 2017
October 2004
April 2008   (Final data collection date for primary outcome measure)
Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization [ Time Frame: six months post vaccine ]
Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population.
Not Provided
Complete list of historical versions of study NCT00103116 on Archive Site
Number of Participants Alive Five Years Post Vaccine [ Time Frame: five years post vaccine ]
Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine
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Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)

RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells may make the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage I, stage II, or stage III non-small cell lung cancer.


  • Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC.
  • Determine the potential clinical efficacy of this vaccine in these patients.

OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical).

Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity.

Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lung Cancer
Biological: autologous dendritic cell cancer vaccine

Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure.

Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.

Other Names:
  • DC vaccine
  • autologous DC vaccine
Experimental: Autologous dendritic cell cancer vaccine
Open label nonrandomized
Intervention: Biological: autologous dendritic cell cancer vaccine

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2008
April 2008   (Final data collection date for primary outcome measure)


  • Histologically confirmed non-small cell lung cancer (NSCLC)

    • Meets 1 of the following stage criteria:

      • Completely resected stage I-IIIB disease

        • Underwent surgical resection > 4 weeks but ≤ 4 years ago
      • Unresectable stage IIIA or IIIB disease AND previously treated with definitive radiotherapy or chemotherapy > 6 weeks ago
    • Bronchoalveolar carcinomas allowed
  • Clinically stable disease by chest x-ray or CT scan within the past 6 weeks

    • No progressive disease
  • No malignant pleural or pericardial effusions



  • 18 to 80

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • Hemoglobin ≥ 9.0 g/dL


  • Bilirubin ≤ 2.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • No known history of infectious hepatitis


  • Creatinine ≤ 3 mg/dL
  • Ionized calcium ≥ 0.9 mmol/L (may be replaced)


  • No known New York Heart Association class III-IV congestive heart failure
  • No hemodynamically significant valvular heart disease
  • No myocardial infarction within the past 6 months
  • No active angina pectoris
  • No uncontrolled ventricular arrhythmia
  • No stroke within the past year
  • No known cerebrovascular disease
  • No other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam)


  • No known HIV positivity
  • No other immunosuppressive disorders, including chronic disorders


  • Not pregnant
  • Negative pregnancy test
  • Potassium ≥ 3.0 mEq/L (may be replaced)
  • Able to tolerate modest blood volume and electrolyte shifts during leukapheresis
  • No other malignancy


Biologic therapy

  • Prior biologic therapy allowed
  • Other concurrent biologic therapy allowed


  • See Disease Characteristics
  • No concurrent chemotherapy

Endocrine therapy

  • No concurrent steroids during and for 16 weeks after study treatment


  • See Disease Characteristics
  • No concurrent radiotherapy


  • See Disease Characteristics


  • Prior neoadjuvant or adjuvant therapy for surgically resected patients allowed
  • No concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment
  • No concurrent chronic immunosuppressive medications
  • Concurrent cyclooxygenase-2 inhibitors allowed
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R21CA091624 ( U.S. NIH Grant/Contract )
UKMC-IRB-0391-F2R ( Other Identifier: IRB )
UKMC-CTRF-G-01-009 ( Other Grant/Funding Number: Cancer Treatment Research Foundation )
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Edward Hirschowitz, University of Kentucky
Edward Hirschowitz
National Cancer Institute (NCI)
Study Chair: Edward Hirschowitz, MD Lucille P. Markey Cancer Center at University of Kentucky
University of Kentucky
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP