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

Primary Purpose

Head and Neck Cancer, Metastatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
recombinant fowlpox-TRICOM vaccine
Sponsored by
National Institute on Deafness and Other Communication Disorders (NIDCD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, skin metastases

Eligibility Criteria

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

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 11, 2001
Last Updated
April 29, 2015
Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
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1. Study Identification

Unique Protocol Identification Number
NCT00021424
Brief Title
Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2002
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Metastatic Cancer
Keywords
stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, skin metastases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
recombinant fowlpox-TRICOM vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Rudy, MSN
Organizational Affiliation
National Institute on Deafness and Other Communication Disorders (NIDCD)
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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