Dendritic Cell Vaccine for Head and Neck Cancer (Dendritic)

April 27, 2021 updated by: University of Maryland, Baltimore

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

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).

Study Overview

Status

Withdrawn

Conditions

Squamous Cell Carcinoma of Head and Neck

Intervention / Treatment

Biological: dendritic cell vaccine

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 Type

Interventional

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland Dept. of Otorhinolaryngology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
safety Time Frame: 5 years	5 years
Efficacy as measured by RECIST criteria Time Frame: 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the immune response to the vaccine Time Frame: 2 years	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Investigators

Principal Investigator: Jeffrey Wolf, MD, University of Maryland, College Park

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2012

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria