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Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed Clinical research trials and Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed clinical trial. Test subjects typically receive the most expert healthcare available for their Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "G" Clinical Trials Conditions > Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed  Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
For Condition: adenocarcinoma of the pancreas,stage 3 pancreatic cancer
Status: Suspended
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Inserting a modified adenovirus gene and tumor necrosis factor (TNF) alpha into a person's tumor cells may make the cancer more sensitive to chemotherapy and radiation therapy. PURPOSE: Randomized phase II trial to study the effectiveness of combining gene therapy (using TNFeradeâ„¢) with chemotherapy and radiation therapy in treating patients who have pancreatic cancer that cannot be surgically removed.
Details: OBJECTIVES: - Determine the safety, feasibility, and activity of intratumoral adenovirus 5-tumor necrosis factor alpha (TNFeradeâ„¢) with fluorouracil and radiotherapy as first-line treatment in patients with unresectable locally advanced pancreatic cancer. - Compare the effectiveness, in terms of median survival, 1-year survival, 6-month survival, 9-month survival, time to tumor progression, and surgical down-staging, of standard chemoradiation with vs without TNFeradeâ„¢ in these patients. OUTLINE: This is a two-part study comprising an open-label, dose-escalation portion followed by a randomized, controlled, multicenter portion. Patients are stratified according to maximum tumor diameter (less than 5 cm vs 5 cm or greater). - Patients receive CT-guided percutaneous injection or endoscopic ultrasound-guided intratumoral adenovirus 5-tumor necrosis factor alpha (TNFeradeâ„¢) once a week for 5 weeks. Patients also receive fluorouracil IV continuously in combination with radiotherapy 5 days a week for 5.5 weeks. Cohorts of 3 patients receive escalating doses of TNFeradeâ„¢ until the MTD is determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Patients are randomized to 1 of 2 treatment arms. - Arm I : Patients receive intratumoral TNFeradeâ„¢, fluorouracil, and radiotherapy as in part I. - Arm II: Patients receive fluorouracil and radiotherapy as in part I. Patients are followed every 3 months for 12 months and then yearly for 5 years. PROJECTED ACCRUAL: A total of 138 patients (18 for part I, 120 for part II) will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven adenocarcinoma of the pancreas - Locally advanced, unresectable disease - No prior treatment for pancreatic cancer - Measurable disease - No islet cell tumor of the pancreas - No lymphoma of the pancreas - No metastatic (stage IV) disease PATIENT CHARACTERISTICS: Age - 18 to 80 Performance status - Karnofsky 70-100% Life expectancy - More than 3 months Hematopoietic - Hematocrit at least 28%* - Hemoglobin at least 9 g/dL* - Platelet count at least 100,000/mm^3 - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 NOTE: *Transfusion allowed Hepatic - ALT and AST no greater than 3 times upper limit of normal (ULN) - Bilirubin no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN - Amylase no greater than 1.5 times ULN - Lipase no greater than 1.5 times ULN - INR no greater than 1.5 - PTT ratio no greater than 1.5 - No clinical evidence of active hepatitis B or C infection Renal - Creatinine no greater than 2.0 mg/dL Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for one year after study - No pancreatitis - No pancreatic pseudocyst - No clinical evidence of active infection - No significant concurrent medical or psychiatric illness - No other malignancy within the past 2 years except: - Carcinoma in situ of the cervix or bladder - Nonmelanoma skin cancer - Localized, early stage prostate cancer PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for pancreatic cancer Endocrine therapy - No chronic systemic corticosteroid use Radiotherapy - No prior radiotherapy for pancreatic cancer - No prior radiotherapy to the target field Surgery - Not specified Other - More than 4 weeks since prior experimental medications - No contraindication to endoscopic ultrasound-guided or percutaneous-guided therapy delivery - No other concurrent investigational agents - No other concurrent anti-cancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoelHecht, Principal Investigator, Jonsson Comprehensive Cancer Center
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-0016
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Washington Cancer Institute
Washington D.C., District of Columbia, 20010-2975
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3833
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-0286
United States
Stanford University Medical Center
Palo Alto, California, 94304-1290
United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, 92868
United States
H. Lee Moffitt Cancer Center CCOP Research Base
Tampa, Florida, 33612-9497
United States
San Francisco General Hospital Medical Center
San Francisco, California, 94110
United States
U.S. Oncology Research, Inc.
Dallas, Texas, 75246
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Additional Information:
Study ID Numbers: CDR0000258136; NCI-G02-2131,UCLA-0207023,GENVEC-GV-001.004
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049647
Other Stage 3 Pancreatic Cancer Studies:
1. Fluorouracil With or Without Cisplatin in Treating Patients With Advanced or Metastatic Cancer of the Pancreas
2. Nitrocamptothecin or Fluorouracil in Treating Patients With Recurrent or Refractory Pancreatic Cancer
3. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
4. Combination Chemotherapy Followed by Chemotherapy and Radiation Therapy and/or Surgery in Treating Patients Who Have Pancreatic Cancer
5. Bevacizumab With or Without Docetaxel in Treating Patients With Previously Treated Metastatic Pancreatic Cancer
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
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