Protocol Number: 03-C-0300
Patients 18 years of age or older with untreated rectal cancer that is confined to the primary tumor site, with or without lymph node involvement, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, CT scans of the chest, abdomen, and pelvis, and MRI or CT scans of the brain, rectal ultrasound, colonoscopy, and review of pathological reports. On admission to the study, participants are weighed and their heart rate, blood pressure, and temperature will be checked. A blood sample is collected for laboratory and research tests. Ten patients are treated with TNFerade, followed by chemotherapy (capecitabine) and radiation in order to gain experience with giving the TNFerade and to see if all tumor can be removed surgically. The remaining patients are then randomly assigned to receive one of two doses of TNFerade (4 X 109 pu or 4 X 1010 pu) or no TNFerade before chemotherapy and radiation. The treatment regimen is as follows: - Radiation therapy to the tumor 5 days a week over a total of 5 weeks; - Capecitabine, by mouth, twice a day for the 5 weeks of radiation therapy; - TNFerade (for those assigned to receive this drug) injected into four sections of the tumor on the first day of radiation therapy and once a week thereafter for 5 weeks during radiation therapy. Blood samples are drawn weekly to check for side effects of chemotherapy during treatment. Tumor biopsies are taken before the first dose of TNFerade or of radiation, then 3 days later, then 3 days before the third dose of TNFerade or radiation, and before the fifth dose of TNFerade or radiation. A minimum 4-week rest period follows the radiation and chemotherapy and then surgery is scheduled to remove all tumors. A temporary or permanent colostomy may be required. Three weeks after surgery, patients return to NIH for blood tests and a CT scan to evaluate the response to treatment and to monitor side effects. Patients with no sign of tumor receive additional standard chemotherapy with 5-fluorouracil and leucovorin. Patients in whom tumor is still evident may receive additional radiation therapy or surgery. Patients will be followed at NIH every 3 months for up to 3 years with a CT scan, physical examination, and blood tests. After this, patients will be followed by telephone or mail every year for up to 15 years to record any hospitalizations, new diagnoses, and progress.
Search The Studies | Help | Questions |
Warren Grant Magnuson Clinical Center (CC) |
||