Dendritic Cell Vaccine for Head and Neck Cancer

This study has been withdrawn prior to enrollment.
(major amendments in progress)
Sponsor:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00492947
First received: June 26, 2007
Last updated: January 10, 2013
Last verified: May 2010
  Purpose

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

Purpose

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 Intervention Phase
Squamous Cell Carcinoma of Head and Neck
Biological: dendritic cell vaccine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by RECIST criteria [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Characterize the immune response to the vaccine [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2007
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: dendritic cell vaccine
    3 vaccinations total: Day 10, Day 20, Day 30
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492947

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

No publications provided

Responsible Party: Jeffrey Wolf, MD, University of Maryland
ClinicalTrials.gov Identifier: NCT00492947     History of Changes
Other Study ID Numbers: HP-00040999
Study First Received: June 26, 2007
Last Updated: January 10, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site

ClinicalTrials.gov processed this record on July 31, 2014