Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Trial of Individualized Mutant p53 Peptide-Pulsed Cultured Autologous Dendritic Cells in the Adjuvant Treatment of Patients With Locally Advanced Non-Small Cell Lung Cancer After Standard Therapy

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: mutant p53 peptide pulsed dendritic cell vaccine
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: mutant p53 peptide pulsed dendritic cell vaccine|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival by CTEP CTC v2.x |  |  | 
| Overall survival by CTEP CTC v2.x |  |  | 
| Toxicity by CTEP CTC v2.x |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological response by ELISPOT before and 2 weeks after last vaccine |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer