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.
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
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.
- First posted8 Sep 2004 (estimated)
- Study startAug 2004
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- Philip M. Arlen, MD, Principal investigator, National Cancer Institute (NCI)
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00091039
- Acronym / sponsor ID
- CDR0000383146
- Conditions
- Lung Cancer
- Keywords
- stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Aug 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 8 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant fowlpox GM-CSF vaccine adjuvant | Biological | – |
| recombinant fowlpox-CEA(6D)/TRICOM vaccine | Biological | – |
| recombinant vaccinia-CEA(6D)-TRICOM vaccine | Biological | – |
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip M. Arlen, MD principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
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.