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

June 18, 2013 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease-free survival by CTEP CTC v2.x
Overall survival by CTEP CTC v2.x
Toxicity by CTEP CTC v2.x

Secondary Outcome Measures

Outcome Measure
Immunological response by ELISPOT before and 2 weeks after last vaccine

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jay A. Berzofsky, MD, PhD, NCI - Vaccine Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

June 20, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

November 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067284
  • NCI-99-C-0142
  • VU-VCC-THO-9814
  • NCI-T96-0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Clinical Trials on adjuvant therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe