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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Carboplatin; Metronidazole; Paclitaxel; Vaccines

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