Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer

April 29, 2015 updated by: National Institute on Deafness and Other Communication Disorders (NIDCD)

Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases.
  • Determine the safety profile of this regimen in these patients.
  • Determine the clinical activity of this regimen, in terms of inflammation at injection site(s) and disease regression or stabilization, in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant fowlpox-TRICOM vaccine (rF-TRI) intralesionally once on weeks 0, 3, and 8. Beginning on week 16, patients may receive additional rF-TRI once every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of rF-TRI until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

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
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed stage IV squamous cell carcinoma of the oral cavity or oropharynx or nodal or dermal metastases for which current available treatment is not likely to offer a survival advantage or result in significant palliation

    • Unresectable locoregional recurrence after maximum radiotherapy OR

    • Local disease with unresectable distant metastases involving:

      • Base of skull
      • Prevertebral fascia
      • Deep neck muscles
      • Carotid artery (requiring resection)
      • Nasopharynx and/or pterygoid muscles
  • Ineligible to receive radiotherapy to head and neck during study
  • Primary intraoral lesions must be measurable and accessible to intralesional injections
  • No metastatic brain lesions, cerebral metastasis, or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • At least 2 months

Hematopoietic:

  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 100,000/mm^3
  • Hemoglobin greater than 8 g/dL

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • AST/ALT less than 4 times upper limit of normal (ULN)
  • PT/PTT less than 1.5 times ULN

Renal:

  • Creatinine less than 2.0 mg/dL OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular:

  • No evidence of congestive heart failure
  • No serious cardiac dysrhythmia
  • No evidence of recent prior myocardial infarction on EKG
  • No clinical coronary artery disease

Neurologic:

  • No history of seizures or concurrent seizure disorder
  • No evidence of encephalitis, multiple sclerosis, or other structural brain lesion(s) by clinical or radiological evaluation

Immunologic:

  • No risk of immune system compromise
  • HIV negative
  • No hypersensitivity to eggs
  • No significant history of allergies (e.g., anaphylaxis or angioedema)

Other:

  • No active or chronic infection
  • No other serious concurrent medical illness
  • No other malignancy unless previously treated with curative intent and no evidence of persistent or recurrent disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

  • No more than 2 prior chemotherapy regimens
  • At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

  • At least 4 weeks since prior systemic corticosteroids
  • No concurrent systemic corticosteroids

Radiotherapy:

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No prior radiotherapy to more than 50% of nodal groups

Surgery:

  • More than 4 weeks since prior surgery for primary or metastatic lesions and recovered
  • No prior splenectomy

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

Collaborators and Investigators

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

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

  • Study Chair: Susan Rudy, MSN, National Institute on Deafness and Other Communication Disorders (NIDCD)

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, 2001

Study Registration Dates

First Submitted

July 11, 2001

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

August 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068782
  • NCI-01-DC-0006
  • NCI-3210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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