Completed

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)

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What is being tested

Data Collection

Who is being recruted

Bronchial Neoplasms+7

+ Carcinoma, Bronchogenic

+ Carcinoma, Non-Small-Cell Lung

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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) 
NCT00088725NCT00091039
Principal SponsorNational Cancer Institute (NCI)
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic Neoplasms

Criteria

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, United StatesSee the location
CompletedOne Study Center