vaccine therapy and sargramostim in treating patients with non-small cell lung cancer

Conditions: 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.

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 criteria:
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

Keywords: stage i non-small cell lung cancer stage ii non-small cell lung cancer large cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer