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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014