Squamous Cell CarcinomaPhase 1NCT00937300
T-cell Based Immunotherapy for Head and Neck Cancer
A Phase 1 study testing cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2 in people with Squamous Cell Carcinoma and Head and Neck Cancer, run by Inge Marie Svane at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2009to Jun 2011
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to 1. Acceptable CBC and blood chemistry results. Acceptable organ functions.
Who cannot join
- Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Oncology, Copenhagen University Hospital, Herlev
Herlev, 2730
About this study
Official title: T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
The aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.
Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.
- Conditions
- Squamous Cell Carcinoma, Head and Neck Cancer
- Being tested
- cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2Biological
Also called Cyclophosphamide, Sendoxan®, Baxter A/S, Fludarabine, Fludara®, Bayer Shering, Interleukin-2, Proleukin®, Chiron B.V.
Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks.
What is being measured
The primary outcome is the main question the study is designed to answer.
toxicity
Measured: week 0 to 20
Secondary outcomes (1)
immune response
Measured: week 0 to 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: The patients eligible for this trial do not exist anymore due to change in procedures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inge Marie Svane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inge Marie Svane, Herlev Hospital
- Investigators
- Inge Marie Svane, Professor, MD, Study director, Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937300
- Sponsor's protocol ID
- HH0908
- Status last verified
- Nov 2011
- First submitted
- 10 Jul 2009
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Based Immunotherapy for Treatment of Patients Squamous Cell Carcinoma in the Oral Cavity. A Pilot Study.
- ClinicalTrials.gov ID
- NCT00937300
- Acronym / sponsor ID
- HH0908
- Conditions
- Squamous Cell Carcinoma, Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The patients eligible for this trial do not exist anymore due to change in procedures.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inge Marie SvaneUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 13 Jul 2009 (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 aim of this study is to investigate the toxicity and immune response of therapy with tumor infiltrating lymphocytes as adjuvant treatment for head and neck cancer after primary operation and radiotherapy.
Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity and immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with histological proven squamous cell carcinoma T3 or more in the oral cavity planned for primary surgery. Performance Status 0 to 1. Acceptable CBC and blood chemistry results. Acceptable organ functions.
Key exclusion criteria (1 listed)
- Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
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 |
|---|---|---|
| cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2Also: Cyclophosphamide, Sendoxan®, Baxter A/S, Fludarabine, Fludara®, Bayer Shering, Interleukin-2, Proleukin®, Chiron B.V.Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. | Biological | – |
Primary outcome
toxicity
Time frame: week 0 to 20
1 secondary outcome
immune response
Time frame: week 0 to 20
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 23 Nov 2011.
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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.
Inge Marie Svane, Professor, MD study director
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
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 cyclophosphamide, fludarabine, T-cell infusion, and Interleukin-2 in people with Squamous Cell Carcinoma and Head and Neck Cancer, run by Inge Marie Svane at 1 site in Denmark.
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 1 inclusion and 1 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 23 Nov 2011. 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 Denmark. 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?
toxicity (time frame: week 0 to 20). 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 Nov 2011.