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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-04-C-0252 | |||
| NCI-6439 |
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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.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
DISEASE CHARACTERISTICS:
Histologically confirmed non-small cell lung cancer
Unresectable disease
Carcinoembryonic antigen (CEA)-positive (staining ≥ 20% of cells) tumor by immunohistochemistry
HLA-A2-positive
No distant metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
HIV negative
No altered immune function
No active or history of eczema
No atopic dermatitis
No autoimmune disease, including any of the following:
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:
No other active malignancy within the past 2 years
No other concurrent serious illness
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
No concurrent steroids, except for any of the following:
No steroid eye-drops for at least 3 weeks after vaccinia vaccination
No concurrent hormonal therapy
No concurrent systemic glucocorticoids
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Philip M. Arlen, MD | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland | 20892-1182 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D017239 | Paclitaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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