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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

Phase 1
18 Years
Not Enrolling
Squamous Cell Carcinoma of Head and Neck

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Jeffrey Wolf, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland


United States: Food and Drug Administration

Study ID:




Start Date:

June 2007

Completion Date:

June 2012

Related Keywords:

  • Squamous Cell Carcinoma of Head and Neck
  • Phase I
  • dendritic cell
  • vaccine
  • intra tumoral
  • squamous cell carcinoma
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



University of Maryland Dept. of Otorhinolaryngology Baltimore, Maryland  21201