Expired Study
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Lexington, Kentucky 40536


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00103116


Primary Contact:

Study Chair
Edward Hirschowitz, MD
Lucille P. Markey Cancer Center at University of Kentucky


Backup Contact:

N/A


Location Contact:

Lexington, Kentucky 40536
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 10, 2017

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