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Study Title: A Randomized Phase II/III of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer
Category: Gastroenterology
Currently accepting participants?
Yes - please read the description below and contact the study coordinator if you are interested.
Principal Investigator: Andrew Ross
Study Coordinator: Jody Mooney
Phone: 206 341 1452 Ext.11452
Email: gasjcm@vmmc.org
What is the A Randomized Phase II/III of TNFerade™ Biologic With 5-FU and Radiation Therapy for First-Line Treatment of Unresectable Locally Advanced Pancreatic Cancer study?
The purpose of this study is to compare the effects of TNFerade™ Biologic with 5-FU and radiation therapy with 5-FU and radiation therapy alone on patients with pancreatic cancer to see which is better. There are two parts to this study. The first part was called the dose-escalation phase that is completed. In the second part of the study, all participants will get 5-FU and radiation therapy, followed by gemcitabine therapy. TNFerade biologic will be administered by direct intratumoral injection using endoscopic ultrasound (EUS)-guided fine needle injection.
TNFerade biologic (AdGVEGR.TNF.11D) is a replication-deficient serotype 5 adenovirus vector devoid of the basic integrating and replicating machinery (E1, E4, and partial E3 genes), which provides a high gene transfer efficiency. The rationale for the proposed study is that the addition of TNFerade biologic to standard therapy (external radiotherapy and 5-FU, followed by gemcitabine or gemcitabine/erlotinib maintenance therapy) may improve local control, reduce regional recurrences and improve quality of life and survival.
Possible Side effects includes; fatigue, fever, nausea, inflammation of the esophagus, vomiting, chills, rapid heartbeat, weakness, pain, and anorexia the most frequent side effects considered related to TNFerade? Biologic. The most common side effects that were thought to be possibly caused by TNFerade? Biologic included fever, chills, nausea, fatigue, anorexia, vomiting, pain at the site of injection, low blood pressure, and diarrhea
Who can participate?
The study population will consist of adults between the ages of 18 and 75, with newly diagnosed, unresectable, locally advanced pancreatic cancer and Life expectancy greater than 3 months
What do I have to do as a study participant?
Study Summary:
The purpose of this study is to compare the effects of TNFerade™ Biologic with 5-FU and radiation therapy with 5-FU and radiation therapy alone on patients with pancreatic cancer to see which is better. There are two parts to this study. The first part was called the dose-escalation phase that is completed. In the second part of the study, all participants will get 5-FU and radiation therapy, followed by gemcitabine therapy. TNFerade biologic will be administered by direct intratumoral injection using endoscopic ultrasound (EUS)-guided fine needle injection.
TNFerade biologic (AdGVEGR.TNF.11D) is a replication-deficient serotype 5 adenovirus vector devoid of the basic integrating and replicating machinery (E1, E4, and partial E3 genes), which provides a high gene transfer efficiency. The rationale for the proposed study is that the addition of TNFerade biologic to standard therapy (external radiotherapy and 5-FU, followed by gemcitabine or gemcitabine/erlotinib maintenance therapy) may improve local control, reduce regional recurrences and improve quality of life and survival.
Possible Side effects includes; fatigue, fever, nausea, inflammation of the esophagus, vomiting, chills, rapid heartbeat, weakness, pain, and anorexia the most frequent side effects considered related to TNFerade? Biologic. The most common side effects that were thought to be possibly caused by TNFerade? Biologic included fever, chills, nausea, fatigue, anorexia, vomiting, pain at the site of injection, low blood pressure, and diarrhea
TNFerade biologic (AdGVEGR.TNF.11D) is a replication-deficient serotype 5 adenovirus vector devoid of the basic integrating and replicating machinery (E1, E4, and partial E3 genes), which provides a high gene transfer efficiency. The rationale for the proposed study is that the addition of TNFerade biologic to standard therapy (external radiotherapy and 5-FU, followed by gemcitabine or gemcitabine/erlotinib maintenance therapy) may improve local control, reduce regional recurrences and improve quality of life and survival.
Possible Side effects includes; fatigue, fever, nausea, inflammation of the esophagus, vomiting, chills, rapid heartbeat, weakness, pain, and anorexia the most frequent side effects considered related to TNFerade? Biologic. The most common side effects that were thought to be possibly caused by TNFerade? Biologic included fever, chills, nausea, fatigue, anorexia, vomiting, pain at the site of injection, low blood pressure, and diarrhea
Detailed Study Description:
(No information)
Study Design: Observational
Phase of Study: Phase II / III
Study Type: Observational
Condition or Study Focus: Locally Advanced Pancreatic Cancer
Intervention Type: TNFerade Biologic With 5-FU and Radiation Therapy
Intervention Name: TNFerade
Gender: Male and Female
Age group: Observational
Sponsor: GenVec, Inc.
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