Dendritic Cell Vaccine for Head and Neck Cancer

NCT00492947 | Withdrawn Phase 1 DMC

• 1 other identifier: HP-00040999
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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. 2.To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer.
3. 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).

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

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

Outcome Measures

Primary Outcomes (2)

• safety

  5 years

• Efficacy as measured by RECIST criteria

  5 years

Secondary Outcomes (1)

• Characterize the immune response to the vaccine

  2 years

Interventions

dendritic cell vaccine BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Dept. of Otorhinolaryngology

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms, Squamous Cell

Study Officials

• Jeffrey Wolf, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2012
• Last Updated: April 30, 2021

Record last verified: 2021-04

Locations

US (1)