Patient case: 57-year-old male with lung adenocarcinoma; genetic feature: KRAS (G12V), high tumor mutational burden

Clinical trial: Vaccine Therapy and Sargramostim in Treating Patients With Non-small Cell Lung Cancer

Summary: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood.
  PURPOSE: Phase I trial to study the effectiveness of vaccine therapy and sargramostim in treating patients who have non-small cell lung cancer.

Detailed description: OBJECTIVES:
  -  Determine whether a specific T-cell response can be induced in patients with stage IB-IV non-small cell lung cancer treated with mutant K-ras peptide vaccine (limited to the specific K-ras peptide mutation in their tumors) and sargramostim (GM-CSF).
  -  Determine whether skin test reactivity or HLA type correlates with the induction of anti-K-ras immune responses in patients treated with this regimen.
  -  Determine the toxicity of this regimen in these patients.
  OUTLINE: Patients receive sargramostim (GM-CSF) intradermally (ID) on days 1-10 beginning a maximum of 6 months after complete surgical resection. Patients receive mutant K-ras peptide vaccine (limited to the specific K-ras mutation in their tumors) ID on day 7. Treatment repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
  Patients are followed at 4 and 12 weeks.
  PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 18 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically proven stage IB-IV non-small cell lung cancer
  -  Non-squamous cell histology only
  -  Must have undergone curative surgery within the past 6 months and must be free of recurrence
  -  Tumor must demonstrate a specific K-ras mutation at codon 12 for which a vaccine preparation is available
  PATIENT CHARACTERISTICS:
  Age:
  -  Over 17
  Performance status:
  -  Karnofsky 70-100%
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  WBC at least 3,000/mm^3
  -  Platelet count at least 100,000/mm^3
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Cardiovascular:
  -  No New York Heart Association class III or IV heart disease
  Other:
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  No concurrent medical condition that would preclude compliance or immunologic response to study treatment
  -  No other serious concurrent medical condition
  -  No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the uterine cervix
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  At least 3 weeks since prior postoperative chemotherapy and recovered
  Endocrine therapy:
  -  No concurrent systemic steroids
  -  Concurrent inhaled steroids allowed
  Radiotherapy:
  -  No prior radiotherapy to spleen
  -  At least 3 weeks since prior postoperative radiotherapy and recovered
  Surgery:
  -  See Disease Characteristics
  -  No prior splenectomy
  Other:
  -  No concurrent immunosuppressive drugs or antiinflammatory drugs

Relevance to patient case: possibly relevant