MedDataX Logo

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

NCT ID: NCT00050388

Last Updated: 2008-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Completion Date

2002-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Allovectin-7®

Intervention Type GENETIC

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vical

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Site Status

University of Chicago

Chicago, Illinois, United States

Site Status

Louisiana State University

New Orleans, Louisiana, United States

Site Status

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

University Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VCL-1005-207

Identifier Type: -

Identifier Source: org_study_id

NCT00028457

Identifier Type: -

Identifier Source: nct_alias