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Vaccine Therapy in Treating Patients With 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.
ClinicalTrials.gov Identifier: NCT00019929
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Biological: mutant p53 peptide pulsed dendritic cell vaccine Procedure: adjuvant therapy Phase 2

Detailed Description:


  • Determine the overall survival in patients with locally advanced non-small cell lung cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells after standard therapy.
  • Assess the safety and immunological efficacy of this regimen in terms of inducing or boosting a mutant p53-specific immune response in this patient population.

OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks. Patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations.

Patients are followed for 5 years.

PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy
Study Start Date : August 2000
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Disease-free survival by CTEP CTC v2.x
  2. Overall survival by CTEP CTC v2.x
  3. Toxicity by CTEP CTC v2.x

Secondary Outcome Measures :
  1. Immunological response by ELISPOT before and 2 weeks after last vaccine

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations:

    • Point mutation altering the protein sequence
    • Frame-shift mutation with the generation of a novel sequence
  • No significant pleural effusions visible on plain chest radiography
  • Must have completed or plan to undergo curative intent therapy for NSCLC

    • At least 2 courses of neoadjuvant chemotherapy for patients with known N2 or N3 resectable disease OR
    • At least 55 Gy radiotherapy with concurrent or sequential chemotherapy for patients with unresectable disease
    • Patients with incidental N2 or N3 disease at time of surgery may receive optional adjuvant chemotherapy and radiotherapy



  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Lymphocyte count greater than 475/mm^3
  • Granulocyte count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin less than 2.0 mg/dL
  • SGOT less than 3 times normal
  • Albumin at least 3.0 g/dL
  • No signs of acute hepatitis B infection

    • Hepatitis B surface antigen positive allowed provided there are no signs of chronic active hepatitis
  • No prior hepatitis C infection


  • Creatinine less than 2.5 mg/dL
  • Calcium less than 11.0 mg/dL (corrected for albumin)


  • No myocardial infarction or significant ventricular arrhythmias within the past 6 months


  • No other malignancy within the past 5 years unless curatively treated and probability of recurrence is less than 5%
  • HIV negative
  • No psychiatric or other condition that would preclude study
  • No serious ongoing infection
  • No other serious medical condition that would limit life expectancy to less than 2 years
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy and no anticipated need for chemotherapy for at least 2 months after vaccinations

Endocrine therapy:

  • At least 4 weeks since prior supraphysiologic steroids and no anticipated need for steroid therapy for at least 2 months after vaccinations


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and no anticipated need for radiotherapy for at least 2 months after vaccinations


  • See Disease Characteristics


  • No influenza vaccination if egg allergy present
  • At least 4 weeks and no greater than 24 weeks since completion of all prior modalities for primary therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019929

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Jay A. Berzofsky, MD, PhD NCI - Vaccine Branch
Read EJ, Carter CS, Lee J, et al.: Clinical scale preparation of antigen-pulsed mature autologous dendritic cells for tumor-specific immunotherapy. [Abstract] ISHAGE 2001 Seventh Annual Symposium A-100, 2001.

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ClinicalTrials.gov Identifier: NCT00019929    
Obsolete Identifiers: NCT00001829
Other Study ID Numbers: CDR0000067284
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: November 2005
Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms