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

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.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma of the Head and Neck Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Lip Diseases Lip Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Respiratory Tract Diseases Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Oral Cavity or Oropharynx Stomatognathic Diseases Tongue Diseases Tongue Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Alabama, Birmingham, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Allovectin-7®

Genetic

Sponsors and collaborators

Lead sponsor

Vical

Industry

Registry information

Official study 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

Important dates

Study completion: 2002
First posted: Dec 9, 2002
Registry last updated: Jun 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting