Patient case: 68-year-old male with non-small cell carcinoma; genetic feature: MET

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.

Detailed 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: 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

Relevance to patient case: not relevant