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TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer Clinical research trials and TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer. TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer  TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer
TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer
For Condition: Rectal Neoplasms
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will examine whether giving combination therapy with the drugs TNFerade plus capecitabine and radiation therapy before surgery in patients with rectal cancer is more effective than capecitabine and radiation therapy alone before surgery. TNFerade is a modified live virus that is used to insert the TNF-alpha gene into tumor cells. TNF-alpha, also known as tumor necrosis factor, is a substance produced by the immune system that has been used as an anticancer agent. 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.
Details: Cancers of the colon and rectum are the second leading cause of cancer death in the United States. Rectal cancers present a particular challenge for the local control given the anatomic considerations of the pelvis and their propensity to invade radially. The goal of therapy is to allow for the complete resection of these tumors while preserving sphincter function whenever possible. Combinations of pre-operative radiation and 5FU based chemotherapy followed by surgery result in complete pathologic responses in roughly 10-25% of cases. This trial is designed to determine if the local injection of a replication incompetent adenoviral vector carrying a radiation inducible TNF construct followed by radiation and chemotherapy can improve the complete pathologic response rate when compared to radiation and chemotherapy alone at the time of definitive surgical resection of locally advanced rectal cancers. Secondary endpoints will include disease free and overall survival as well as measurements of local and systemic gene product levels and determinations of changes in gene expression profiles as well as proteomic analysis of tumor tissue prior to, during and following therapy.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: All patients greater than or equal to 18 years old who have biopsy proven T3 or T4 rectal cancer which is confined to the primary tumor site with or without regional lymph node involvement. Rectal cancer will be defined as any adenocarcinoma of the rectum located below the peritoneal reflection excluding Paget's disease of the anus. The T status will be ascertained by transrectal ultrasound when possible. Patients with obstructive/circumferential lesions will be staged by CT scan and clinical exam. Patients must be willing to return for follow-up. Patients must be able to give and sign informed consent. Patients must be suitable candidates for surgical resection post-chemoradiation, i.e. no history of severe congestive heart failure or severe pulmonary disease. ECOG less than or equal to 2. Life expectancy greater than 6 months. EXCLUSION CRITERIA: Patients with evidence of distant metastatic disease. Any of the following hematologic abnormalities: a. HGB less than 8.0 gm/dl unable to be corrected with a transfusion. b. Absolute neutrophil count (ANC) less than 1500 cells/mm(3). c. Platelets less than 100,000/mm(3). d. APTT ratio or INR greater than 1.5 (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation and whose anti-thrombotic can not be withheld for vector injection or surgery). A history of hepatic cirrhosis or present hepatic dysfunction with: a. Total bilirubin greater than 2.0 mg/dl except for patients with Gilbert's syndrome who must have a direct bilirubin less than or equal to 1.0 mg/dl. b. AST/ALT greater than or equal to 2.5 times upper limit of normal. Renal insufficiency as determined by a serum creatinine greater than 2.0 mg/dl. Patients may not have received prior therapy with chemotherapy, biologic therapy or radiation therapy for their rectal cancer. Significant history of a medical problem that would preclude the patient from undergoing an operative procedure such as a history of severe congestive heart failure or active ischemic heart disease. Concurrent second malignancy requiring systemic therapy. Pregnant or lactating women, or men/women unable or unwilling to practice contraception. Chronic systemic corticosteroid use. Prior surgery for rectal cancer.
Total Enrollment: 95
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030300; 03-C-0300
Study Start Date: September 13, 2003
Record last reviewed: September 9, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069147
Other Rectal Neoplasms Studies:
1. Treatment of patients with previously treated metastatic colorectal cancer with oxaliplatin/5FU/LV and PTK787 or placebo
2. First-line treatment of metastatic colorectal cancer with oxaliplatin/5-FU/leucovorin plus PTK787/ZK 222584 or placebo
3. A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery
4. TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer
Related Studies:
Other Rectal Neoplasms Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
TNFerade, Capecitabine, and Radiation Therapy to Treat Rectal Cancer
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