Dendritic Cell Vaccine for Head and Neck Cancer - Full Text View

Sponsored by:	University of Maryland
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00492947

Purpose

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

Purpose

This research study is being done to:

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).
To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer.
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 I

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	10
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:

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

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

Contacts

Contact: Jeffrey Wolf, MD

410-328-1887

jwolf@smail.umaryland.edu

Locations

United States, Maryland
University of Maryland Dept. of Otorhinolaryngology	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Jennifer DeSanto, RN, MS 410-328-6215 jdesanto@smail.umaryland.edu
Principal Investigator: Jeffrey Wolf, MD

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Jeffrey Wolf, MD

University of Maryland

More Information

Responsible Party:	University of Maryland ( Jeffrey Wolf, MD )
Study ID Numbers:	H-27834
Study First Received:	June 26, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00492947
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Maryland:

Phase I
dendritic cell
vaccine
intra tumoral
squamous cell carcinoma

Study placed in the following topic categories:

Epidermoid carcinoma
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Carcinoma, squamous cell of head and neck
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009