Dendritic Cell Vaccine for Head and Neck Cancer (Dendritic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00492947
Recruitment Status : Withdrawn (major amendments in progress)
First Posted : June 27, 2007
Last Update Posted : January 11, 2013
Information provided by:
University of Maryland

Brief Summary:

This research study is testing a new treatment of cancer of the head and neck.


This research study is being done to:

  1. Test the safety of the experimental cancer vaccine made of dendritic cells. An experimental vaccine is one that is not approved by the Food and Drug Administration (FDA).
  2. To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer.
  3. To learn if the vaccine will stimulate your body's white blood cells, which are part of your immune system (your body's natural defense system).

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Biological: dendritic cell vaccine Phase 1

Detailed Description:
White blood cells are part of the body's defense system. Sometimes when you have cancer, your body does not know that the cancer cells are making you sick. We hope to teach your white blood cells to find and destroy your cancer cells with a vaccine. The vaccine will be made from a special kind of blood cell called a dendritic cell. This is the cell that will carry the information about your cancer to your white blood cells in your body.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 0608 GCC:Phase I Study of Intra-tumoral Injection of Dendritic Cells for the Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study Start Date : June 2007
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Biological: dendritic cell vaccine
    3 vaccinations total: Day 10, Day 20, Day 30

Primary Outcome Measures :
  1. safety [ Time Frame: 5 years ]
  2. Efficacy as measured by RECIST criteria [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Characterize the immune response to the vaccine [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Squamous cell carcinoma of the head and neck in patients with unresectable recurrent disease or distant metastasis or patients who fail conventional radiation therapy and/or chemotherapy and refuse surgical salvage.
  • Presence of cervical metastasis that is able to be accessed for injection
  • Biopsy accessible tumor (metastatic or primary)
  • >18 years of age.
  • The following laboratory values obtained ≤14 days prior to registration:

    • ANC ≥1500
    • PLT ≥100,000
    • Hgb ≥ 9.0 g/dL
    • Alkaline phosphatase ≤3 x UNL
    • AST ≤3 x UNL
    • Creatinine ≤1.5 x UNL
  • Life expectancy ≥6 months.
  • ECOG performance status 0, 1, or 2.
  • No chemotherapy for prior 4 weeks.

Exclusion Criteria:

  • Pregnant women.
  • Nursing women.
  • Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device {IUD}, abstinence.)
  • Known HIV infection.
  • Concurrent use of systemic immunosuppressants.
  • Other immunocompromising condition that in the opinion of the physician renders the patient a poor candidate for this trial.
  • Other active cancer requiring therapy to control the disease.
  • Unwillingness to return for follow-up evaluations over a period of up to 2 years following completion of protocol therapy.
  • Other intercurrent medical problems that, in the opinion of the investigator, would make participation in the study hazardous for the patient
  • Patients in whom the otolaryngologist, radiation oncologist, and medical oncologist can not agree on a consensus node to treat.
  • Patients with CNS metastasis or involvement of sites where an inflammatory response would constitute an immediately life threatening situation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00492947

United States, Maryland
University of Maryland Dept. of Otorhinolaryngology
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Jeffrey Wolf, MD University of Maryland

Responsible Party: Jeffrey Wolf, MD, University of Maryland Identifier: NCT00492947     History of Changes
Other Study ID Numbers: HP-00040999
First Posted: June 27, 2007    Key Record Dates
Last Update Posted: January 11, 2013
Last Verified: May 2010

Keywords provided by University of Maryland:
Phase I
dendritic cell
intra tumoral
squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Immunologic Factors
Physiological Effects of Drugs