Vaccine Therapy in Treating Patients Who Are Undergoing Surgery for Stage IB, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Lung Cancer

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer Clinical stage IB-IIIA disease Candidate for surgical resection as primary treatment for tumor Surgically resectable tumor ≥ 2.0 cm in diameter No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Platelet count ≥ 100,000/mm^3 WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Hematocrit ≥ 30% Hepatic Hepatitis B surface antigen negative* Hepatitis B core antigen negative* Hepatitis C virus negative* Bilirubin ≤ 2.0 mg/dL AST and ALT ≤ 2 times upper limit of normal NOTE: *Screening performed only if liver enzymes are elevated Renal Creatinine ≤ 2.2 mg/dL BUN ≤ 40 mg/dL Pulmonary FEV_1 > 2.0 L (pre-resection) OR Predicted post-resection FEV_1 > 1.0 L No more than 2 chronic obstructive pulmonary disease exacerbations requiring > 2 weeks of oral steroids and/or hospitalization within the past year Immunologic Purified protein derivative (PPD) skin test negative HIV-1 and HIV-2 negative No acute infection, including any acute viral, bacterial, or fungal infection requiring specific therapy within the past 7 days No allergy to study agents No known autoimmune or collagen vascular disorder Other Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix No underlying condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent anti-tumor necrosis factor agents Chemotherapy Standard adjuvant chemotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine No concurrent cyclophosphamide Endocrine therapy No concurrent high-dose corticosteroids (e.g., > 10 mg of prednisone) Concurrent corticosteroids for minor breathing exacerbations allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period No concurrent corticosteroids within 48 hours before or after study vaccine administration Radiotherapy Standard adjuvant radiotherapy for lung cancer allowed provided therapy is completed ≥ 30 days before administration of the first study vaccine Surgery No prior organ allograft Other No concurrent antihistamines within 48 hours before or after study vaccine administration No concurrent cimetidine or other H2 blockers within 48 hours before or after study vaccine administration Concurrent antibiotics for minor infection allowed provided patient receives ≤ 2 short courses (≤ 10 days per course) within a 45-day period No concurrent cyclosporine No concurrent azathioprine No other concurrent drugs known to significantly alter immune function No concurrent cytotoxic therapy No concurrent participation in another clinical trial involving experimental therapy No other concurrent anticancer therapy
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA