Dendritic Cell Vaccine for Head and Neck Cancer

Withdrawn before enrolling · Phase 1

Conditions studied: Squamous Cell Carcinoma of Head and Neck

In brief

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).

Key facts

Study ID

NCT00492947

Run by

University of Maryland, Baltimore

People needed

0

Starts

2007-06-01

Expected to finish

2012-06-01

Last updated by the study team

2021-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Maryland Dept. of Otorhinolaryngology — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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