Vaccine Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: autologous dendritic cell cancer vaccine
Intervention description: 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.
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; bronchoalveolar 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.
    

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