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Lung CancerNCT00091039

Vaccine Therapy, Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed With Surgery

A study testing recombinant fowlpox GM-CSF vaccine adjuvant, recombinant fowlpox-CEA(6D)/TRICOM vaccine and recombinant vaccinia-CEA(6D)-TRICOM vaccine in people with Lung Cancer, run by National Cancer Institute (NCI) at 1 site 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 made from a gene-modified virus may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
recombinant fowlpox GM-CSF vaccine adjuvant, recombinant fowlpox-CEA(6D)/TRICOM vaccine and recombinant vaccinia-CEA(6D)-TRICOM vaccine
Type of treatment
Vaccines, Surgery or procedure
How many people
Not given
Where
1 siteUnited States
Study dates
Aug 2004to Feb 2006
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer
  • Stage III (locally advanced) disease
  • Unresectable disease
  • Carcinoembryonic antigen (CEA)-positive (staining ≥ 20% of cells) tumor by immunohistochemistry
  • HLA-A2-positive
  • No distant metastases

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Absolute lymphocyte count ≥ 600/mm^3
  • Hemoglobin ≥ 10 g/dL

Hepatic

  • Bilirubin < 1.5 mg/dL
  • AST ≤ 2 times upper limit of normal
  • Hepatitis B and C negative

Renal

  • Creatinine normal OR
  • Creatinine clearance > 60 mL/min

Cardiovascular

  • No unstable or newly diagnosed angina pectoris
  • No myocardial infarction within the past 6 months
  • No New York Heart Association class II-IV congestive heart failure

Immunologic

  • HIV negative
  • No altered immune function
  • No active or history of eczema
  • No atopic dermatitis
  • No autoimmune disease, including any of the following:
  • Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
  • Systemic lupus erythematosus
  • Sjögren's syndrome
  • Scleroderma
  • Myasthenia gravis
  • Goodpasture's syndrome
  • Addison's disease
  • Hashimoto's thyroiditis
  • Active Graves' disease
  • Multiple sclerosis
  • No known history of allergy or serious reaction to prior vaccination with vaccina
  • No known allergy to eggs
  • No active or history of extensive psoriasis, severe acneiform rash, impetigo, varicella zoster, burns, or other traumatic or pruritic skin condition

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 4 months after study participation
  • No history of seizures or encephalitis
  • Able to avoid close household contact with the following individuals for at least 3 weeks after vaccinia vaccination:
  • Children under 3 years of age
  • Pregnant or nursing women
  • Individuals with a history of or active eczema or other eczematoid skin disorders
  • Individuals with other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, impetigo, burns, varicella zoster, severe acne, or other open rashes or wounds)
  • Immunodeficient or immunosuppressed individuals, including HIV-positive persons, by disease or therapy
  • No other active malignancy within the past 2 years
  • No other concurrent serious illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • At least 3 years since prior immunotherapy with related vaccinia and fowlpox vaccines
  • At least 3 years since prior antigen-specific peptides
  • No other concurrent immunotherapy

Chemotherapy

  • No prior paclitaxel or carboplatin for lung cancer
  • At least 3 years since prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent steroids, except for any of the following:
  • Topical steroids
  • Inhaled steroids for mild or moderate asthma
  • Dexamethasone as premedication for paclitaxel OR for short-term doses (48-72 hours in duration) to control refractory nausea that is not responding to other antiemetics
  • Systemic corticosteroids for ≥ grade 3 radiation pneumonitis
  • No steroid eye-drops for at least 3 weeks after vaccinia vaccination
  • No concurrent hormonal therapy
  • No concurrent systemic glucocorticoids

Radiotherapy

  • No prior radiotherapy to the lung fields
  • No prior thoracic radiotherapy for lung cancer
  • No other concurrent radiotherapy

Surgery

  • Surgical scars must be healed
  • No prior splenectomy
  • No concurrent major surgical procedure

Other

  • Recovered from all prior therapy
  • No other concurrent anticancer agent or therapy

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, 20892-1182

Other trials in United States

About this study

Official title: A Pilot Trial of a CEA/TRICOM-Based Vaccine in Combination With Combined Chemotherapy/Radiotherapy in Patients With Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)

RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells. Combining vaccine therapy with chemotherapy and radiation therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying how well giving vaccine therapy together with paclitaxel, carboplatin, and radiation therapy works in treating patients with stage III non-small cell lung cancer that cannot be removed with surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the safety and feasibility of standard paclitaxel, carboplatin, and radiotherapy in combination with vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, and recombinant fowlpox GM-CSF vaccine in patients with unresectable stage III non-small cell lung cancer.

Secondary

  • Determine clinical response in patients treated with this regimen.
  • Determine time to disease progression and overall median survival of patients treated with this regimen.
  • Determine immunologic response in patients treated with this regimen.

OUTLINE: This is a pilot study.

  • Vaccine: Patients receive vaccinia-CEA-TRICOM vaccine subcutaneously (SC) on day 0 and fowlpox-CEA-TRICOM (rF-CEA-TRICOM) vaccine SC on days 14, 29, 43, 57, 70, 91, and 112. Patients also receive recombinant fowlpox GM-CSF (rF-GM-CSF) vaccine SC with each vaccination. Patients with stable or responding disease after day 112 continue to receive rF-CEA-TRICOM and rF-GM-CSF SC every 3 weeks in the absence of disease progression or unacceptable toxicity.
  • Radiotherapy: Patients undergo radiotherapy on days 21-25, 28-32, 35-39, 42-46, 49-53, 56-60, and 63-67.
  • Chemotherapy: Concurrently with radiotherapy, patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 21, 28, 35, 42, 49, 56, and 63. Patients also receive paclitaxel and carboplatin on days 91 and 112 (after completion of radiotherapy).

Patients are followed annually for up to 15 years.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4-6 months.

Conditions
Lung Cancer
Being tested
recombinant fowlpox GM-CSF vaccine adjuvant, recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)-TRICOM vaccine, carboplatin, paclitaxel
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.

  • recombinant fowlpox GM-CSF vaccine adjuvantBiological

  • recombinant fowlpox-CEA(6D)/TRICOM vaccineBiological

  • recombinant vaccinia-CEA(6D)-TRICOM vaccineBiological

  • carboplatinDrug

  • paclitaxelDrug

  • radiation therapyRadiation

Timeline

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

  1. First posted8 Sep 2004 (estimated)
  2. Study startAug 2004
  3. Study completionFeb 2006

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 N/A
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091039
Sponsor's protocol ID
CDR0000383146
Other IDs
NCI-04-C-0252, NCI-6439
Status last verified
Dec 2005
First submitted
7 Sep 2004
Last updated
20 Jun 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing recombinant fowlpox GM-CSF vaccine adjuvant, recombinant fowlpox-CEA(6D)/TRICOM vaccine and recombinant vaccinia-CEA(6D)-TRICOM vaccine in people with Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

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

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

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 1 site 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.

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.

Where can I read the original study information?
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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