NCT00050388

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Vical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
GENETIC	Allovectin-7®

Timeline

• Completion: 2002-06-01
• First posted: 2002-12-09
• Last updated: 2008-06-24

Locations

10 sites across 1 country: United States