Dendritic Cell Vaccine for Head and Neck Cancer

Phase 1

Withdrawn

• Conditions: Squamous Cell Carcinoma of Head and Neck

• Registration Number: NCT00492947
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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).

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.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-26
• Study First Submitted QC: 2007-06-26
• Study First Posted: 2007-06-27
• Primary Completion: 2010-06
• Study Completion: 2012-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
safety	5 years
Efficacy as measured by RECIST criteria	5 years

Secondary Outcome Measures

Name	Time	Method
Characterize the immune response to the vaccine	2 years

Trial Locations

Locations (1)

University of Maryland Dept. of Otorhinolaryngology; 🇺🇸 Baltimore, Maryland, United States