Head and Neck CancerPhase 1NCT00021424
Vaccine Therapy in Treating Patients With Stage IV Head and Neck Cancer
A Phase 1 study testing recombinant fowlpox-TRICOM vaccine in people with Head and Neck Cancer and Metastatic Cancer, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Metastatic Cancer
- What is being tested?
- recombinant fowlpox-TRICOM vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jun 2001to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Warren Grant Magnuson Clinical Center
Bethesda, Maryland, 20892-1182
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer, Metastatic Cancer
- Being tested
- recombinant fowlpox-TRICOM vaccine
- 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
- Medical subject headings
- Head and Neck Neoplasms, Neoplasm Metastasis, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant fowlpox-TRICOM vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Susan Rudy, MSN, Study chair, National Institute on Deafness and Other Communication Disorders (NIDCD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00021424
- Sponsor's protocol ID
- CDR0000068782
- Other IDs
- NCI-01-DC-0006, NCI-3210
- Status last verified
- Aug 2002
- First submitted
- 11 Jul 2001
- Last updated
- 30 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00021424
- Acronym / sponsor ID
- CDR0000068782
- Conditions
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD)US National Institutes of Health
- Study start
- Jun 2001
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant fowlpox-TRICOM vaccine | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Rudy, MSN study chair
National Institute on Deafness and Other Communication Disorders (NIDCD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing recombinant fowlpox-TRICOM vaccine in people with Head and Neck Cancer and Metastatic Cancer, run by National Institute on Deafness and Other Communication Disorders (NIDCD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2015.