Protocol Number: 03-C-0300
Patients ages 18 or older with Stage II or III cancer and who do not have a history of serious heart disease may be eligible for this study. Patients will undergo a physical examination and blood collection. Before patients are assigned randomly to groups, 10 will be treated with 4 x(10)10 pu, a dose level of TNFerade[TM], followed by chemotherapy with capecitabine and radiation, to evaluate the drug and determine whether the tumor can be removed by surgery. Then two patient groups will be assigned to receive the drug before administration of chemotherapy and radiation: one with a dose of 4 x(10)10 pu, and the other with 4 x(9)10 pu. TNFerade[TM] will be injected into four sections of the tumor. There will be four biopsies done of the tumor, one before the treatment is given, and then at three other stages. All patients will receive additional chemotherapy after the tumor is removed through surgery, and all will receive radiation therapy to the tumor 5 days a week, over a period of 5 to 7 weeks. All patients will receive capecitabine orally twice a day during the weeks of radiation therapy. During chemotherapy treatment, about 2 tablespoons of blood will be drawn for examination. If patients develop side effects, the dose of capecitabine may be reduced or delayed. Blood levels will be measured for TNFerade[TM] as well. Following completion of 5 weeks of chemotherapy and radiation, patients will have a 4-week rest. If a physical exam and lab results show that it is safe to proceed with surgery, patients will be scheduled for surgery at the Clinical Center. Then about 3 weeks after surgery, patients will return to NIH for a blood test and a computed tomography (CT) scan to see if the tumor has returned and to watch for side effects from treatment. If there is no sign of the tumor, patients will begin standard chemotherapy with appropriate drugs. If not all of the tumor has been removed, there may be additional radiation therapy or surgery. Patients will be asked to return to NIH every 3 months for up to 3 years, for a CT scan and lab tests.
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008
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