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Brief Title: Phase II Trial of Allovectin-7® for Head and Neck Cancer
Official Title: Phase II Study of the Safety and Efficacy of Allovectin-7® Immunotherapy for the Treatment of Primary, Resectable Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Study ID: NCT00050388
Brief Summary: The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression.
Detailed Description: Treatment - If you take part in this trial you will be treated for about four weeks. You will receive an injection of Allovectin-7® by needle, directly into your tumor. This will be repeated 14 days later. The injections may be given in a doctor's office. A week later, you will undergo surgery to remove the tumor. Your tumor will be measured before Allovectin-7® treatment and before surgery to see if Allovectin-7® was effective in shrinking it. This will be done by general physical exams and scans (such as X-ray scans). There will also be tests on the removed tumor to see if Allovectin-7® helped to boost the immune system to attack the cancer.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama, Birmingham, Birmingham, Alabama, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
University of Chicago, Chicago, Illinois, United States
Louisiana State University, New Orleans, Louisiana, United States
University of Michigan Medical Center, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
University Cincinnati Medical Center, Cincinnati, Ohio, United States
Case Western Reserve University, Cleveland, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States