Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
This trial is active, not recruiting.
|Treatment||therapeutic autologous dendritic cells|
|Sponsor||University of Kentucky|
|Collaborator||National Cancer Institute (NCI)|
|Start date||October 2004|
|End date||April 2008|
|Trial size||60 participants|
|Trial identifier||NCT00103116, CDR0000410830, R21CA091624, UKMC-CTRF-G-01-009, UKMC-IRB-0391-F2R|
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.
|Intervention model||single group assignment|
time frame: July/2005-Oct/2007
Comparison of clinical outcomes to historical controls
time frame: July/2005-May/2012
Male or female participants from 18 years up to 80 years old.
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
|Official title||Autologous Dendritic Cell Vaccines in Non-small Cell Lung Cancer (NSCLC)|
|Description||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.|
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