Protocol Number: 04-C-0252
Patients 18 years of age and older with stage III inoperable lung cancer whose tumors produce CEA and who are tissue type HLA-A2 may be eligible for this study. (HLA type is a genetic marker of the immune system and is tested in a manner similar to blood type testing.) Candidates are screened with a medical history and physical examination, blood and urine tests, electrocardiogram (ECG), computerized tomography (CT) or magnetic resonance imaging (MRI) scans, and a lung function test, if recent studies are not available. Participants undergo the following procedures: - Vaccine, Chemotherapy, and Radiation Treatment: Patients receive the priming vaccination on study day 0 and a boosting vaccine every 2 weeks (study days 14, 29, 43, 57 and 70) and then two more boosting vaccines on days 91 and 112. With every vaccination patients also receive an injection of sargramostim to increase the effectiveness of the vaccine. All vaccine and sargramostim doses are given as injections under the skin. In addition to the vaccine treatment, patients have radiation to the tumor on study days 21-25, 28--32, 35-39, 42-46, 49-53, 56-60, and 63-67. Low-dose chemotherapy with paclitaxel and carboplatin are given on days 21, 28, 35, 42, 56, 63, 91, and 112. Dexamethasone, diphenhydramine, and rantinidine or cimetidine are given with the chemotherapy to reduce the drugs' side effects. Patients are monitored closely for treatment side effects with blood and urine tests and with clinic visits every 2 to 3 weeks. They may also have repeat imaging scans to assess the status of their cancer. Patients whose disease does not worsen during treatment and who do not experience serious side effects may continue to receive the boosting vaccine every 3 weeks after day 112. - Apheresis: Patients undergo apheresis, a procedure for collecting immune cells called lymphocytes, on study days 0, 21, 70, and 133. For this procedure, blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components by spinning, and the lymphocytes are extracted. The rest of the blood is returned to the patient through the same needle. The collected lymphocytes are studied to measure the immune response to treatment. - Fiberoptic bronchoscopy and lavage: For this procedure to examine the lungs, the patient's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the airways (trachea and bronchi) to examine them carefully. Biopsy specimens are obtained with a biopsy forcep. Saline (salt water) is then injected through the bronchoscope into the air passage, acting as a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content.
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