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Lung CancerPhase 2NCT00019929

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

A Phase 2 study testing mutant p53 peptide pulsed dendritic cell vaccine and adjuvant therapy in people with Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Lung Cancer
What is being tested?
mutant p53 peptide pulsed dendritic cell vaccine and adjuvant therapy
Type of treatment
Vaccines, Surgery or procedure
How many people
Not given
Where
2 sitesUnited States
Study dates
Aug 2000to Dec 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Lung Cancer
Being tested
mutant p53 peptide pulsed dendritic cell vaccine, adjuvant therapy
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mutant p53 peptide pulsed dendritic cell vaccineBiological

  • adjuvant therapyProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 outcomes (1)
  1. Immunological response by ELISPOT before and 2 weeks after last vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startAug 2000
  3. Study completionDec 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00019929
Sponsor's protocol ID
CDR0000067284
Other IDs
NCI-99-C-0142, VU-VCC-THO-9814, NCI-T96-0045
Status last verified
Nov 2005
First submitted
11 Jul 2001
Last updated
20 Jun 2013
Results posted
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing mutant p53 peptide pulsed dendritic cell vaccine and adjuvant therapy in people with Lung Cancer, run by National Cancer Institute (NCI) at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival by CTEP CTC v2.x. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00019929, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.

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