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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms, Carcinoma of the Head and Neck

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

VCL-1005-207

NCT ID:

NCT00050388

Start Date:

Completion Date:

June 2002

Related Keywords:

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

Name

Location

Louisiana State UniversityNew Orleans, Louisiana  70112-2282
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of Michigan Medical CenterAnn Arbor, Michigan  48104-0914
Henry Ford Health SystemDetroit, Michigan  48202
Case Western Reserve UniversityCleveland, Ohio  44106
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of ChicagoChicago, Illinois  60637
University of Alabama, BirminghamBirmingham, Alabama  35233
University Cincinnati Medical CenterCincinnati, Ohio  45267