Status:
COMPLETED
Vaccine Therapy, Chemotherapy, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed With Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wa...
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 reco...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00091039
Start Date
August 1 2004
End Date
February 1 2006
Last Update
June 20 2013
Active Locations (1)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182