Lung Cancer
Conditions
Keywords
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Brief 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.
Detailed description
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival by CTEP CTC v2.x | — |
| Overall survival by CTEP CTC v2.x | — |
| Toxicity by CTEP CTC v2.x | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological response by ELISPOT before and 2 weeks after last vaccine | — |
Countries
United States