Head and Neck CancerPhase 1/2NCT00496535
A Study of TNFerade™ Biologic With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) in Patients With Head and Neck Cancer
A Phase 1/2 study testing TNFerade biologic in people with Head and Neck Cancer and Head and Neck Neoplasms, run by GenVec at 1 site in United States.
Trial summary
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent 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, Head and Neck Neoplasms
- What is being tested?
- TNFerade biologic
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1/2
- 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
Who may be able to join
- Head and neck cancer
- Patients must have a locoregional tumor amenable to reirradiation with curative intent.
- disease, or the majority of disease, should be accessible to injection via direct intratumoral injection
- Life expectancy of greater than 12 weeks
- Age > 18 years
- ECOG performance status 0-1
Who cannot join
- Metastatic disease
- History of malignancy (other than head and neck cancer) in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
- Patients may not be receiving any other investigational agents currently or within the 4 weeks prior to study Day 1
- Active infection of any type
- Chronic treatment for greater than 6 months with steroids
- Pregnant or lactating women
Show all 11Show fewer
- Patients with known history of cerebral vascular disease; stroke or TIA within the last 6 months
- Patients with history of documented thrombosis (PE or DVT), or known coagulopathy or thrombophilia, or evidence of DVT / thromboembolic event upon enrollment
- Patients receiving hormone replacement therapy or hormonal contraceptives within two weeks of day 1
- Patients who have undergone surgery within the last 1 month prior to day 1
- Patients with active carotid artery involvement or status post carotid artery graft / stenting
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Safety, Tolerability, and "Proof of Concept" Study of TNFerade™ Biologic in Combination With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) for Patients With Unresectable Recurrent Head and Neck Cancer
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms
- Being tested
- TNFerade biologic
- Keywords
- head, neck, cancer, neoplasm
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNFerade biologicDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
locoregional control at 24 months
Secondary outcomes (1)
Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- GenVec
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Everett Vokes, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496535
- Sponsor's protocol ID
- GV-001.011
- Other IDs
- GV-001.011 (TNF-CORE)
- Status last verified
- May 2011
- First submitted
- 2 Jul 2007
- Last updated
- 23 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Safety, Tolerability, and "Proof of Concept" Study of TNFerade™ Biologic in Combination With Concomitant Radiotherapy, Fluorouracil, and Hydroxyurea (TNF-FHX) for Patients With Unresectable Recurrent Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00496535
- Acronym / sponsor ID
- GV-001.011
- Conditions
- Head and Neck Cancer, Head and Neck Neoplasms
- Keywords
- head, neck, cancer, neoplasm
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- GenVecIndustry (pharma, biotech, devices)
- First posted
- 4 Jul 2007 (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.
The primary objective of the first phase is to determine the safety, the maximum tolerated dose (MTD) and dose-limiting toxicity of TNFerade in combination with the previously studied combination of Fluorouracil (5FU), Hydroxyurea (HU) and standard daily radiotherapy in patients with recurrent head and neck cancer (RHNC). All chemoradiotherapy is administered on a "week-on/week-off" schedule. The primary objective of the second phase II is to determine the locoregional control rate at 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Head and neck cancer
- Patients must have a locoregional tumor amenable to reirradiation with curative intent.
- disease, or the majority of disease, should be accessible to injection via direct intratumoral injection
- Life expectancy of greater than 12 weeks
- Age > 18 years
Key exclusion criteria (11 listed)
- Metastatic disease
- History of malignancy (other than head and neck cancer) in the last 2 years except carcinoma in situ of the cervix or bladder, non-melanomatous skin cancer, or localized early stage prostate cancer, with patients continually disease free, or cancers that are not felt to influence treatment for head and neck cancer and life expectancy of patient
- Patients may not be receiving any other investigational agents currently or within the 4 weeks prior to study Day 1
- Active infection of any type
- Chronic treatment for greater than 6 months with steroids
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 |
|---|---|---|
| TNFerade biologic | Drug | – |
Primary outcome
locoregional control at 24 months
1 secondary outcome
Locoregional control at 3, 6 and 12 months, as well as tumor response rate, progression-free survival at 3, 6, 12 and 24 months, and the rate of metastases at 3, 6, 12 and 24 months will also be assessed.
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 23 Feb 2012.
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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.
Everett Vokes, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TNFerade biologic in people with Head and Neck Cancer and Head and Neck Neoplasms, run by GenVec 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?
The sponsor lists 6 inclusion and 11 exclusion criteria. 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 23 Feb 2012. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
locoregional control at 24 months. It is what the study was designed to measure, not a finding.
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 23 Feb 2012.