Patient case: 14-year-old female with Li-Fraumeni syndrome; genetic feature: TP53

Clinical trial: Vaccine Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.
  PURPOSE: This phase II trial is studying vaccine therapy given after standard therapy to see how well it works in treating patients with stage III non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine the overall survival in patients with locally advanced non-small cell lung cancer immunized with adjuvant mutant p53 peptide-pulsed autologous dendritic cells after standard therapy.
  -  Assess the safety and immunological efficacy of this regimen in terms of inducing or boosting a mutant p53-specific immune response in this patient population.
  OUTLINE: Patients undergo p53 gene mutation analysis. Patients without a suitable gene mutation receive no vaccination. Patients with a suitable p53 gene mutation receive mutant p53 peptide-pulsed autologous dendritic cells IV over 1-2 minutes weekly for 5 weeks. Patients achieving an immune response with no evidence of progressive disease may receive additional vaccinations every 2 months for a maximum of 10 immunizations.
  Patients are followed for 5 years.
  PROJECTED ACCRUAL: Approximately 120 patients (40 on the vaccination arm) will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed stage IIIA or IIIB non-small cell lung cancer (NSCLC) with one of the following p53 mutations:
  -  Point mutation altering the protein sequence
  -  Frame-shift mutation with the generation of a novel sequence
  -  No significant pleural effusions visible on plain chest radiography
  -  Must have completed or plan to undergo curative intent therapy for NSCLC
  -  At least 2 courses of neoadjuvant chemotherapy for patients with known N2 or N3 resectable disease OR
  -  At least 55 Gy radiotherapy with concurrent or sequential chemotherapy for patients with unresectable disease
  -  Patients with incidental N2 or N3 disease at time of surgery may receive optional adjuvant chemotherapy and radiotherapy
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Performance status:
  -  ECOG 0-1
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Lymphocyte count greater than 475/mm^3
  -  Granulocyte count greater than 1,000/mm^3
  -  Platelet count greater than 100,000/mm^3
  Hepatic:
  -  Bilirubin less than 2.0 mg/dL
  -  SGOT less than 3 times normal
  -  Albumin at least 3.0 g/dL
  -  No signs of acute hepatitis B infection
  -  Hepatitis B surface antigen positive allowed provided there are no signs of chronic active hepatitis
  -  No prior hepatitis C infection
  Renal:
  -  Creatinine less than 2.5 mg/dL
  -  Calcium less than 11.0 mg/dL (corrected for albumin)
  Cardiovascular:
  -  No myocardial infarction or significant ventricular arrhythmias within the past 6 months
  Other:
  -  No other malignancy within the past 5 years unless curatively treated and probability of recurrence is less than 5%
  -  HIV negative
  -  No psychiatric or other condition that would preclude study
  -  No serious ongoing infection
  -  No other serious medical condition that would limit life expectancy to less than 2 years
  -  Not pregnant or nursing
  -  Negative pregnancy test
  -  Fertile patients must use effective contraception
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  -  At least 4 weeks since prior chemotherapy and no anticipated need for chemotherapy for at least 2 months after vaccinations
  Endocrine therapy:
  -  At least 4 weeks since prior supraphysiologic steroids and no anticipated need for steroid therapy for at least 2 months after vaccinations
  Radiotherapy:
  -  See Disease Characteristics
  -  At least 4 weeks since prior radiotherapy and no anticipated need for radiotherapy for at least 2 months after vaccinations
  Surgery:
  -  See Disease Characteristics
  Other:
  -  No influenza vaccination if egg allergy present
  -  At least 4 weeks and no greater than 24 weeks since completion of all prior modalities for primary therapy

Relevance to patient case: not relevant