vaccine therapy in treating patients with stage iii non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: this phase ii trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage iii non-small cell lung cancer.

objectives: * determine the overall survival in patients with locally advanced non-small cell lung cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells after standard therapy. * assess the safety and immunological efficacy of this regimen in terms of inducing or boosting a mutant p53-specific immune response in this patient population. outline: patients undergo p53 gene mutation analysis. patients without a suitable gene mutation receive no vaccination. patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells iv over 1-2 minutes weekly for 5 weeks. patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations. patients are followed for 5 years. projected accrual: approximately 120 patients (40 on the vaccination arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed stage iiia or iiib non-small cell lung cancer (nsclc) with one of the following p53 mutations: * point mutation altering the protein sequence * frame-shift mutation with the generation of a novel sequence * no significant pleural effusions visible on plain chest radiography * must have completed or plan to undergo curative intent therapy for nsclc * at least 2 courses of neoadjuvant chemotherapy for patients with known n2 or n3 resectable disease or * at least 55 gy radiotherapy with concurrent or sequential chemotherapy for patients with unresectable disease * patients with incidental n2 or n3 disease at time of surgery may receive optional adjuvant chemotherapy and radiotherapy patient characteristics: age: * not specified performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * lymphocyte count greater than 475/mm\^3 * granulocyte count greater than 1,000/mm\^3 * platelet count greater than 100,000/mm\^3 hepatic: * bilirubin less than 2.0 mg/dl * sgot less than 3 times normal * albumin at least 3.0 g/dl * no signs of acute hepatitis b infection * hepatitis b surface antigen positive allowed provided there are no signs of chronic active hepatitis * no prior hepatitis c infection renal: * creatinine less than 2.5 mg/dl * calcium less than 11.0 mg/dl (corrected for albumin) cardiovascular: * no myocardial infarction or significant ventricular arrhythmias within the past 6 months other: * no other malignancy within the past 5 years unless curatively treated and probability of recurrence is less than 5% * hiv negative * no psychiatric or other condition that would preclude study * no serious ongoing infection * no other serious medical condition that would limit life expectancy to less than 2 years * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy and no anticipated need for chemotherapy for at least 2 months after vaccinations endocrine therapy: * at least 4 weeks since prior supraphysiologic steroids and no anticipated need for steroid therapy for at least 2 months after vaccinations radiotherapy: * see disease characteristics * at least 4 weeks since prior radiotherapy and no anticipated need for radiotherapy for at least 2 months after vaccinations surgery: * see disease characteristics other: * no influenza vaccination if egg allergy present * at least 4 weeks and no greater than 24 weeks since completion of all prior modalities for primary therapy

Keywords: stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer