Head and Neck CancerPhase 3NCT00050388
Phase II Trial of Allovectin-7® for Head and Neck Cancer
A Phase 3 study testing Allovectin-7® in people with Head and Neck Cancer and Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, run by Vical at 10 sites in United States.
Trial summary
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms
- What is being tested?
- Allovectin-7®
- How many people
- Not given
- Where
- 10 sitesUnited States
- Study dates
- Start not givento Jun 2002
- Phase
- Phase 3
- 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
In order to be in this trial, you must meet the enrollment criteria. Below is a list of some of the enrollment criteria.
- You have been diagnosed with head and neck cancer (also called squamous cell carcinoma of the mouth)
- You have Stage I or Stage II disease (a single mouth tumor which has not spread to other areas of the body)
- Surgery to remove your tumor is recommended
- You have not received any prior therapy for head and neck cancer (e.g. radiation or chemotherapy)
- You are able to carry out your normal daily activities
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Alabama, Birmingham
Birmingham, Alabama, 35233
University of Chicago
Chicago, Illinois, 60637
University Cincinnati Medical Center
Cincinnati, Ohio, 45267
Case Western Reserve University
Cleveland, Ohio, 44106
Henry Ford Health System
Detroit, Michigan, 48202
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Louisiana State University
New Orleans, Louisiana, 70112
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
About this study
Official title: Phase II Study of the Safety and Efficacy of Allovectin-7® Immunotherapy for the Treatment of Primary, Resectable Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
The purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression.
Read the detailed description
Treatment - If you take part in this trial you will be treated for about four weeks. You will receive an injection of Allovectin-7® by needle, directly into your tumor. This will be repeated 14 days later. The injections may be given in a doctor's office. A week later, you will undergo surgery to remove the tumor. Your tumor will be measured before Allovectin-7® treatment and before surgery to see if Allovectin-7® was effective in shrinking it. This will be done by general physical exams and scans (such as X-ray scans). There will also be tests on the removed tumor to see if Allovectin-7® helped to boost the immune system to attack the cancer.
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms, Carcinoma of the Head and Neck
- Being tested
- Allovectin-7®
- Keywords
- Cancer, Carcinoma, Neoplasm, Head cancer, Neck cancer, Tongue cancer, Lip cancer, Oral Cavity, Oropharynx, Pharynx, Larynx, Squamous Cell, Salivary Glands, Tumor, Lesion, Cancer treatment, Clinical trial, Allovectin-7®, Otorhinolaryngologic Neoplasm, Otolaryngologic Cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasms, Carcinoma, Tongue Neoplasms, Lip Neoplasms, Laryngeal Diseases, Otorhinolaryngologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allovectin-7®Genetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2002 (estimated)
- Study completionJun 2002
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Vical
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00050388
- Sponsor's protocol ID
- VCL-1005-207
- Status last verified
- Jun 2008
- First submitted
- 6 Dec 2002
- Last updated
- 24 Jun 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of the Safety and Efficacy of Allovectin-7® Immunotherapy for the Treatment of Primary, Resectable Squamous Cell Carcinoma of the Oral Cavity or Oropharynx
- ClinicalTrials.gov ID
- NCT00050388
- Acronym / sponsor ID
- VCL-1005-207
- Conditions
- Head and Neck Cancer, Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, Head and Neck Neoplasms, Carcinoma of the Head and Neck
- Keywords
- Cancer, Carcinoma, Neoplasm, Head cancer, Neck cancer, Tongue cancer, Lip cancer, Oral Cavity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- VicalIndustry (pharma, biotech, devices)
- Study completion
- Jun 2002
- First posted
- 9 Dec 2002 (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 purpose of this clinical trial is to determine if Allovectin-7®, an experimental gene-based immunotherapy, can shrink head and neck tumors. The trial will also examine if treatment can boost the immune system and if this treatment can improve the time to disease progression.
Detailed description
Treatment - If you take part in this trial you will be treated for about four weeks. You will receive an injection of Allovectin-7® by needle, directly into your tumor. This will be repeated 14 days later. The injections may be given in a doctor's office. A week later, you will undergo surgery to remove the tumor. Your tumor will be measured before Allovectin-7® treatment and before surgery to see if Allovectin-7® was effective in shrinking it. This will be done by general physical exams and scans (such as X-ray scans). There will also be tests on the removed tumor to see if Allovectin-7® helped to boost the immune system to attack the cancer.
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
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 |
|---|---|---|
| Allovectin-7® | Genetic | – |
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 24 Jun 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allovectin-7® in people with Head and Neck Cancer and Squamous Cell Carcinoma of the Oral Cavity or Oropharynx, run by Vical at 10 sites 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 24 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 24 Jun 2008.