Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00019929
First received: July 11, 2001
Last updated: June 18, 2013
Last verified: November 2005
  Purpose

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 Intervention Phase
Lung Cancer
Biological: mutant p53 peptide pulsed dendritic cell vaccine
Procedure: adjuvant therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Disease-free survival by CTEP CTC v2.x [ Designated as safety issue: No ]
  • Overall survival by CTEP CTC v2.x [ Designated as safety issue: No ]
  • Toxicity by CTEP CTC v2.x [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunological response by ELISPOT before and 2 weeks after last vaccine [ Designated as safety issue: No ]

Study Start Date: August 2000
Study Completion Date: December 2005
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • 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

Renal:

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

Cardiovascular:

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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • See Disease Characteristics

Other:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019929

Locations
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
Investigators
Study Chair: Jay A. Berzofsky, MD, PhD NCI - Vaccine Branch
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00019929     History of Changes
Obsolete Identifiers: NCT00001829
Other Study ID Numbers: CDR0000067284, NCI-99-C-0142, VU-VCC-THO-9814, NCI-T96-0045
Study First Received: July 11, 2001
Last Updated: June 18, 2013
Health Authority: United States: Federal Government

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014