Squamous Cell Carcinoma of Head and NeckPhase 1DendriticNCT00492947
Dendritic Cell Vaccine for Head and Neck Cancer
A Phase 1 study testing dendritic cell vaccine in people with Squamous Cell Carcinoma of Head and Neck, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This research study is testing a new treatment of cancer of the head and neck. Purpose This research study is being done to: 1. Test the safety of the experimental cancer vaccine made of dendritic cells. An experimental vaccine is one that is not approved by the Food and Drug Administration (FDA). 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- dendritic cell vaccine
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2012
- 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
Who may be able to join
- Squamous cell carcinoma of the head and neck in patients with unresectable recurrent disease or distant metastasis or patients who fail conventional radiation therapy and/or chemotherapy and refuse surgical salvage.
- Presence of cervical metastasis that is able to be accessed for injection
- Biopsy accessible tumor (metastatic or primary)
- >18 years of age.
- The following laboratory values obtained ≤14 days prior to registration:
- ANC ≥1500
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- PLT ≥100,000
- Hgb ≥ 9.0 g/dL
- Alkaline phosphatase ≤3 x UNL
- AST ≤3 x UNL
- Creatinine ≤1.5 x UNL
- Life expectancy ≥6 months.
- ECOG performance status 0, 1, or 2.
- No chemotherapy for prior 4 weeks.
Who cannot join
- Pregnant women.
- Nursing women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device {IUD}, abstinence.)
- Known HIV infection.
- Concurrent use of systemic immunosuppressants.
- Other immunocompromising condition that in the opinion of the physician renders the patient a poor candidate for this trial.
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- Other active cancer requiring therapy to control the disease.
- Unwillingness to return for follow-up evaluations over a period of up to 2 years following completion of protocol therapy.
- Other intercurrent medical problems that, in the opinion of the investigator, would make participation in the study hazardous for the patient
- Patients in whom the otolaryngologist, radiation oncologist, and medical oncologist can not agree on a consensus node to treat.
- Patients with CNS metastasis or involvement of sites where an inflammatory response would constitute an immediately life threatening situation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Dept. of Otorhinolaryngology
Baltimore, Maryland, 21201
About this study
Official title: 0608 GCC:Phase I Study of Intra-tumoral Injection of Dendritic Cells for the Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
This research study is testing a new treatment of cancer of the head and neck.
Purpose
This research study is being done to:
- Test the safety of the experimental cancer vaccine made of dendritic cells. An experimental vaccine is one that is not approved by the Food and Drug Administration (FDA).
- To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer.
- To learn if the vaccine will stimulate your body's white blood cells, which are part of your immune system (your body's natural defense system).
Read the detailed description
White blood cells are part of the body's defense system. Sometimes when you have cancer, your body does not know that the cancer cells are making you sick. We hope to teach your white blood cells to find and destroy your cancer cells with a vaccine. The vaccine will be made from a special kind of blood cell called a dendritic cell. This is the cell that will carry the information about your cancer to your white blood cells in your body.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- dendritic cell vaccine
- Keywords
- Phase I, dendritic cell, vaccine, intra tumoral, squamous cell carcinoma
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dendritic cell vaccineBiological
3 vaccinations total: Day 10, Day 20, Day 30
What is being measured
The primary outcome is the main question the study is designed to answer.
safety
Measured: 5 years
Efficacy as measured by RECIST criteria
Measured: 5 years
Secondary outcomes (1)
Characterize the immune response to the vaccine
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2010 (estimated)
- Study completionJun 2012 (estimated)
Why it stopped: major amendments in progress
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Wolf, MD, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492947
- Sponsor's protocol ID
- HP-00040999
- Acronym
- Dendritic
- Status last verified
- Apr 2021
- First submitted
- 26 Jun 2007
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 0608 GCC:Phase I Study of Intra-tumoral Injection of Dendritic Cells for the Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00492947
- Acronym / sponsor ID
- Dendritic / HP-00040999
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Keywords
- Phase I, dendritic cell, vaccine, intra tumoral, squamous cell carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: major amendments in progress
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 27 Jun 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.
This research study is testing a new treatment of cancer of the head and neck.
Purpose
This research study is being done to:
- Test the safety of the experimental cancer vaccine made of dendritic cells. An experimental vaccine is one that is not approved by the Food and Drug Administration (FDA).
- To learn what effects (good and bad) the vaccine will have on you and your head and neck cancer.
- To learn if the vaccine will stimulate your body's white blood cells, which are part of your immune system (your body's natural defense system).
Detailed description
White blood cells are part of the body's defense system. Sometimes when you have cancer, your body does not know that the cancer cells are making you sick. We hope to teach your white blood cells to find and destroy your cancer cells with a vaccine. The vaccine will be made from a special kind of blood cell called a dendritic cell. This is the cell that will carry the information about your cancer to your white blood cells in your body.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 (14 listed)
- Squamous cell carcinoma of the head and neck in patients with unresectable recurrent disease or distant metastasis or patients who fail conventional radiation therapy and/or chemotherapy and refuse surgical salvage.
- Presence of cervical metastasis that is able to be accessed for injection
- Biopsy accessible tumor (metastatic or primary)
- >18 years of age.
- The following laboratory values obtained ≤14 days prior to registration:
Key exclusion criteria (11 listed)
- Pregnant women.
- Nursing women.
- Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device {IUD}, abstinence.)
- Known HIV infection.
- Concurrent use of systemic immunosuppressants.
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 |
|---|---|---|
| dendritic cell vaccine3 vaccinations total: Day 10, Day 20, Day 30 | Biological | – |
Primary outcome
safety
Time frame: 5 years
Efficacy as measured by RECIST criteria
Time frame: 5 years
1 secondary outcome
Characterize the immune response to the vaccine
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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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.
Jeffrey Wolf, MD principal investigator
University of Maryland, College Park
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 dendritic cell vaccine in people with Squamous Cell Carcinoma of Head and Neck, run by University of Maryland, Baltimore 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 14 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: withdrawn, as of the sponsor's last update on 30 Apr 2021. 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 was withdrawn before enrolling participants, so there are no results.
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?
safety (time frame: 5 years). The study lists 2 primary outcomes in all. 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 30 Apr 2021.