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

This study has been completed.
Sponsor:
Information provided by:
Vical
ClinicalTrials.gov Identifier:
NCT00050388
First received: December 6, 2002
Last updated: June 20, 2008
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Head and Neck Neoplasms
Carcinoma of the Head and Neck
Genetic: Allovectin-7®
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Vical:

Estimated Study Completion Date: June 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050388

Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, Florida
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Louisiana
Louisiana State University
New Orleans, Louisiana, United States, 70112
United States, Michigan
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Ohio
University Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Vical
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00050388     History of Changes
Obsolete Identifiers: NCT00028457
Other Study ID Numbers: VCL-1005-207
Study First Received: December 6, 2002
Last Updated: June 20, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Vical:
Cancer
Carcinoma
Neoplasm
Head cancer
Neck cancer
Tongue cancer
Lip cancer
Oral Cavity
Oropharynx
Pharynx
Larynx
Squamous Cell
Salivary Glands
Tumor
Lesion
Cancer treatment
Clinical trial
Allovectin-7®
Otorhinolaryngologic Neoplasm
Otolaryngologic Cancer
Gene therapy
Immunotherapy
Cancer research
Cancer vaccine
Cancer cells

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on August 28, 2014