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

Vical

Status and phase

Completed

Phase 3

Conditions

Carcinoma of the Head and Neck

Head and Neck Neoplasms

Head and Neck Cancer

Squamous Cell Carcinoma of the Oral Cavity or Oropharynx

Treatments

Genetic: Allovectin-7®

Study type

Interventional

Funder types

Industry

Identifiers

NCT00050388

VCL-1005-207

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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