Phase II Trial of Allovectin-7® for Head and Neck Cancer

Phase 3

Completed

• Conditions: Head and Neck Cancer; Squamous Cell Carcinoma of the Oral Cavity or Oropharynx; Head and Neck Neoplasms; Carcinoma of the Head and Neck

• Registration Number: NCT00050388
• Lead Sponsor: Vical

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.

Study Timeline

• Study Completion: 2002-06
• Study First Submitted: 2002-12-06
• Study First Submitted QC: 2002-12-06
• Study First Posted: 2002-12-09
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-20
• Last Update Posted: 2008-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (10)

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Louisiana State University; 🇺🇸 New Orleans, Louisiana, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

University of Alabama, Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Michigan Medical Center; 🇺🇸 Ann Arbor, Michigan, United States

Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

University Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States