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Dendritic Cell Vaccine for Head and Neck Cancer (Dendritic)

Primary Purpose

Squamous Cell Carcinoma of Head and Neck

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

dendritic cell vaccine

About this trial

This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck focused on measuring Phase I, dendritic cell, vaccine, intra tumoral, squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Maryland Dept. of Otorhinolaryngology

Outcomes

Primary Outcome Measures

safety

Efficacy as measured by RECIST criteria

Secondary Outcome Measures

Characterize the immune response to the vaccine

Full Information

NCT ID

NCT00492947

First Posted

June 26, 2007

Last Updated

April 27, 2021

Sponsor

University of Maryland, Baltimore

1. Study Identification

Unique Protocol Identification Number

NCT00492947

Brief Title

Dendritic Cell Vaccine for Head and Neck Cancer

Acronym

Dendritic

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Withdrawn

Why Stopped

major amendments in progress

Study Start Date

June 2007 (undefined)

Primary Completion Date

June 2010 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Maryland, Baltimore

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of Head and Neck

Keywords

Phase I, dendritic cell, vaccine, intra tumoral, squamous cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

dendritic cell vaccine

Intervention Description

3 vaccinations total: Day 10, Day 20, Day 30

Primary Outcome Measure Information:

Title

safety

Time Frame

5 years

Title

Efficacy as measured by RECIST criteria

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Characterize the immune response to the vaccine

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey Wolf, MD

Organizational Affiliation

University of Maryland, College Park

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Maryland Dept. of Otorhinolaryngology

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Dendritic Cell Vaccine for Head and Neck Cancer

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