vaccine therapy in treating patients with stage iiib, stage iv, or recurrent non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: vaccines made from peptides may make the body build an effective immune response to kill tumor cells. purpose: this phase ii trial is studying how well vaccine therapy works in treating patients with stage iiib, stage iv, or recurrent non-small cell lung cancer.

objectives: primary * compare the overall survival of patients with hla-a2-positive, stage iiib or iv or recurrent non-small cell lung cancer (nsclc) treated with vaccine therapy comprising ep-2101 emulsified in montanide isa-51 with that of historical controls and patients with hla-a2-negative, stage iiib or iv or recurrent nsclc who undergo observation only. * determine the safety of this vaccine in these patients. secondary * determine progression-free survival of patients treated with this vaccine. * determine the frequency, magnitude, and breadth of cytotoxic and helper t-cell response to vaccine epitopes in patients treated with this vaccine. outline: this is an open-label, multicenter study. patients are assigned to 1 of 2 treatment groups according to hla-a2 status. * group i (hla-a2 positive): patients receive vaccine therapy comprising ep-2101 emulsified in montanide isa-51 subcutaneously once in weeks 0, 3, 6, 9, 12, and 15. * group ii (hla-a2 negative): patients undergo observation in weeks 9 and 18. after completion of study treatment, patients in group i are followed at 3 weeks. all patients are then followed at months 1, 2, 3, 5, and 8, every 3 months for 2 years, and then annually for 2 years. projected accrual: a total of 84 patients will be accrued for this study within 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria: * stage iiib disease * stage iv disease * recurrent disease * hla-a2-positive disease * hla-a2 negative patients are eligible to enroll in group ii (observation) only * measurable disease * estimated tumor volume ≤ 125 cc * no cns signs or symptoms of brain metastases * brain metastases that are clinically stable for ≥ 2 months and do not require anticonvulsants or systemic steroids are allowed patient characteristics: age * 18 and over performance status * ecog 0-1 life expectancy * at least 12 weeks hematopoietic * hemoglobin ≥ 10 g/dl * platelet count \> 100,000/mm\^3 * wbc \> 3,000/mm\^3 * absolute neutrophil count \> 1,500/mm\^3 * absolute lymphocyte count \> 500/mm\^3 hepatic * ast and alt ≤ 2.5 times upper limit of normal (uln) (5 times uln for patients with liver involvement by tumor) * bilirubin ≤ 2.0 mg/dl (3.0 mg/dl for patients with liver involvement by tumor) * albumin ≥ 2.5 g/dl * alkaline phosphatase ≤ 2.5 times uln * no history of hepatitis b or c positivity renal * creatinine ≤ 2 times uln immunologic * no history of any of the following active conditions: * systemic lupus erythematosus * scleroderma * connective tissue disease * sjögren's syndrome * multiple sclerosis * rheumatoid arthritis * inflammatory bowel disease * no history of hiv positivity * no history of serious adverse reaction, including anaphylaxis, or hypersensitivity to study vaccine or to any of its components other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 3 weeks after completion of study treatment * no other malignancy within the past 5 years except curatively excised nonmelanoma skin cancer or surgically cured carcinoma in situ of the cervix * no other acute medical condition that would preclude study treatment * no mental or psychiatric condition that would preclude study compliance prior concurrent therapy: biologic therapy * more than 1 month since prior interferon therapy * more than 1 month since prior interleukin therapy * no prior cancer vaccine therapy, including participation in a vaccine study chemotherapy * at least 4 weeks since prior chemotherapy endocrine therapy * see disease characteristics * more than 1 month since prior systemic corticosteroids except stable doses of inhaled corticosteroids radiotherapy * at least 4 weeks since prior radiotherapy surgery * not specified other * no concurrent participation in another investigational study

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer