Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Vaccines made from a person's white blood cells and allogeneic tumor cells 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 I, stage II, or stage III non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Determine the immunologic effects of adjuvant vaccine therapy comprising autologous dendritic cells loaded with allogeneic non-small cell lung cancer (NSCLC) cells in patients with unresectable stage IIIA or IIIB, or resected stage I-IIIB NSCLC. Determine the potential clinical efficacy of this vaccine in these patients. OUTLINE: This is an open-label study. Patients are stratified according to type of prior primary therapy (surgical vs nonsurgical). Patients undergo leukapheresis over 3-4 hours to harvest mononuclear cells for the production of dendritic cells (DC). DC are then pulsed with allogeneic non-small cell lung cancer cells to produce an autologous dendritic cell vaccine. Patients receive vaccine intradermally once a month for 2 months in the absence of disease recurrence or unacceptable toxicity. Patients are followed monthly for 4 months, every 6 months for 2 years, and then periodically thereafter. PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study within 3 years.

Official Title
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Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)

Conditions
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Lung Cancer

Intervention / Treatment
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* Biological: autologous dendritic cell cancer vaccine


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed non-small cell lung cancer (NSCLC) Meets 1 of the following stage criteria: Completely resected stage I-IIIB disease Underwent surgical resection > 4 weeks but ≤ 4 years ago Unresectable stage IIIA or IIIB disease AND previously treated with definitive radiotherapy or chemotherapy > 6 weeks ago Bronchoalveolar carcinomas allowed Clinically stable disease by chest x-ray or CT scan within the past 6 weeks No progressive disease No malignant pleural or pericardial effusions PATIENT CHARACTERISTICS: Age 18 to 80 Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Hemoglobin ≥ 9.0 g/dL Hepatic Bilirubin ≤ 2.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN No known history of infectious hepatitis Renal Creatinine ≤ 3 mg/dL Ionized calcium ≥ 0.9 mmol/L (may be replaced) Cardiovascular No known New York Heart Association class III-IV congestive heart failure No hemodynamically significant valvular heart disease No myocardial infarction within the past 6 months No active angina pectoris No uncontrolled ventricular arrhythmia No stroke within the past year No known cerebrovascular disease No other significant cardiac disease by echocardiogram, stress test, or risk assessment by cardiologist (for patients suspected of cardiac disease by history or physical exam) Immunologic No known HIV positivity No other immunosuppressive disorders, including chronic disorders Other Not pregnant Negative pregnancy test Potassium ≥ 3.0 mEq/L (may be replaced) Able to tolerate modest blood volume and electrolyte shifts during leukapheresis No other malignancy PRIOR CONCURRENT THERAPY: Biologic therapy Prior biologic therapy allowed Other concurrent biologic therapy allowed Chemotherapy See Disease Characteristics No concurrent chemotherapy Endocrine therapy No concurrent steroids during and for 16 weeks after study treatment Radiotherapy See Disease Characteristics No concurrent radiotherapy Surgery See Disease Characteristics Other Prior neoadjuvant or adjuvant therapy for surgically resected patients allowed No concurrent shorter courses of immunosuppressive medications during and for 16 weeks after study treatment No concurrent chronic immunosuppressive medications Concurrent cyclooxygenase-2 inhibitors allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous dendritic cell cancer vaccine<br>Open label nonrandomized | Biological: autologous dendritic cell cancer vaccine<br>* Dendritic cells made from white blood cells obtained through out-patient leukapheresis procedure. Vaccine given by injection under the skin in the front, upper thigh. Two vaccine injections total, given one month a part.<br>* Other names: autologous DC vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Showing Immunologic Response to Vaccine Within Six Months of Immunization | Antigen specific reaction is measured serially in blood of each participant prior to and through six months post-vaccine. Increase in levels of specific T cell activity from pre vaccine to post vaccine serve as primary measures of an individual's response to vaccine. The number (relative percent) of participants achieving immunologic response to vaccine within 6 month of immunization was the dominant metric of vaccine activity within the study population. | six months post vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Alive Five Years Post Vaccine | Documentation of radiographic surveillance for recurrence or progression for 5 years post-vaccine | five years post 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 I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIB non-small cell lung cancer, bronchoalveolar cell lung cancer