Clinical trial NCT00050388: Phase II Trial of Allovectin-7® for Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
Head and Neck Neoplasms
Carcinoma of the Head and Neck
Keywords: 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
Lead sponsor: Vical
Sponsor class: INDUSTRY
First posted: 2002-12-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Cincinnati
country: United States
facility: University Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: