Patient case: 65-year-old female with squamous cell lung cancer; genetic feature: FGFR1 amplification

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

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.

Eligibility: 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

Relevance to patient case: not relevant