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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050388
• Other study ID #: VCL-1005-207
• Status: Completed
• Phase: Phase 3
• First received: December 6, 2002
• Last updated: June 20, 2008
• Est. completion date: June 2002

Study information

• Verified date: June 2008
• Source: Vical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00028457

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.

• You have been diagnosed with head and neck cancer (also called squamous cell carcinoma of the mouth)

• You have Stage I or Stage II disease (a single mouth tumor which has not spread to other areas of the body)

• Surgery to remove your tumor is recommended

• You have not received any prior therapy for head and neck cancer (e.g. radiation or chemotherapy)

• You are able to carry out your normal daily activities

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Genetic:
• Allovectin-7®

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	University of Chicago	Chicago	Illinois
United States	University Cincinnati Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Louisiana State University	New Orleans	Louisiana
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vical

Country where clinical trial is conducted

United States,