Lung Cancer
Conditions
Keywords
stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer
Brief summary
RATIONALE: Vaccines made from a person's tumor cells and white blood cells may make the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients who are undergoing surgery for stage IB, stage II, or stage IIIA non-small cell lung cancer.
Detailed description
OBJECTIVES: Primary * Determine the maximum tolerated dose of adjuvant autologous dendritic cells loaded with irradiated autologous tumor cells in patients with stage IB-IIIA non-small cell lung cancer undergoing resection. * Determine the safety and tolerability of this vaccine in these patients. Secondary * Determine the feasibility of this vaccine in these patients. * Determine vaccine-specific and antitumor immunity in patients treated with this vaccine. OUTLINE: This is a dose-escalation study. Patients undergo leukaphersis to isolate peripheral blood mononuclear cells (PBMC). PBMC are expanded ex vivo to generate monocyte-derived dendritic cells (DC). Autologous tumor cells are harvested and purified at the time of surgical resection. DC are then loaded with irradiated autologous tumor cells. Within 4-8 weeks after surgical resection, patients receive autologous DC loaded with irradiated autologous tumor cells intradermally on approximately days 1, 30, and 60 in the absence of unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of vaccine until the maximum tolerated dose (MTD) is determined. If 2 of 9 patients in the first cohort experience dose-limiting toxicity, that dose level is considered the MTD. Patients are followed at approximately 1 and 4 months, and then every 6 months for 4 years. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study within 18 months.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States