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

NCT00050388 | Completed Phase 3

• 1 other identifier: VCL-1005-207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 10

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.

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

Interventions

Allovectin-7® GENETIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vical: lead

Study Sites (10)

University of Alabama, Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Louisiana State University

New Orleans, Louisiana, 70112, United States

Location

University of Michigan Medical Center

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Carcinoma; Tongue Neoplasms; Lip Neoplasms; Laryngeal Diseases; Otorhinolaryngologic Neoplasms

Interventions

Allovectin-7

Condition Hierarchy (Ancestors)

Neoplasms by Site; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Tongue Diseases; Lip Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 6, 2002
• First Posted: December 9, 2002
• Study Completion: June 1, 2002
• Last Updated: June 24, 2008

Record last verified: 2008-06

Locations

US (10)