Dendritic Cell Vaccine for Head and Neck Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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

Conditions
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Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment
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* Biological: dendritic cell vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: dendritic cell vaccine|3 vaccinations total: Day 10, Day 20, Day 30|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 5 years | 
| Efficacy as measured by RECIST criteria |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the immune response to the vaccine |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, dendritic cell, vaccine, intra tumoral, squamous cell carcinoma