Lung Cancer Clinical Trial
Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Summary
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.
Full 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.
Eligibility 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
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There is 1 Location for this study
Lexington Kentucky, 40536, United States
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