Head and Neck CancerPhase 1NCT01149902
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
A Phase 1 study testing Cyclophosphamide, Docetaxel, Dendritic cells, OK-432 in people with Head and Neck Cancer, run by University of Yamanashi at 1 site in Japan.
Trial summary
The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
- How many people
- 10 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2010to Mar 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with relapsed and refractory head and neck squamous cell carcinoma
- 20 years and older
- ECOG performance status 0-1
- More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
- Tumor lesions are accessible to intratumoral dendritic cells injection
- Patients who are able to do oral ingestion
Show all 16Show fewer
- Patients must have normal organ and marrow functions as follows:
- Hb>9.0 mg/dl
- Ht>25%
- WBC>4000/mm3
- Platelet count>100,000/mm3
- T-Bil<1.5mg/dl
- GOT<x2.5 institutional upper limit of normal
- GPT<x2.5 institutional upper limit of normal
- Creatinin<1.5mg/dl
- signed informed consent
Who cannot join
- Less than 20 years
- Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
- Patients with clinically active infection
- Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
- Concomitant malignant diseases, brain metastases
- Psychiatric illness
- Treatment with steroids
- Decision of unsuitableness by physician
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Umiversity of Yamanashi Hospital
Chūō, Yamanashi, 409-3898
Hiroki Ishii, MD, +81-55-273-6769, ishiih@yamanashi.ac.jp
Keisuke Masuyama, MD, PhD
About this study
Official title: Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma
The purpose of this study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.
- Conditions
- Head and Neck Cancer
- Being tested
- Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide, Docetaxel, Dendritic cells, OK-432Biological
Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and feasibility of chemo-immunotherapy
Measured: 1 year
Secondary outcomes (1)
The number and function of immune effector cells in treated patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJul 2010
- Primary completionMar 2012 (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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Yamanashi
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01149902
- Sponsor's protocol ID
- 631
- Status last verified
- Jun 2010
- First submitted
- 22 Jun 2010
- Last updated
- 24 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01149902
- Acronym / sponsor ID
- 631
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of YamanashiUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Mar 2012 (estimated)
- First posted
- 24 Jun 2010 (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 study is to determine safety and feasibility of Chemo-Immunotherapy using cyclophosphamide, docetaxel, OK-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- The patients with relapsed and refractory head and neck squamous cell carcinoma
- 20 years and older
- ECOG performance status 0-1
- More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
- Tumor lesions are accessible to intratumoral dendritic cells injection
Key exclusion criteria (8 listed)
- Less than 20 years
- Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
- Patients with clinically active infection
- Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
- Concomitant malignant diseases, brain metastases
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, Docetaxel, Dendritic cells, OK-432Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35 | Biological | – |
Primary outcome
The safety and feasibility of chemo-immunotherapy
Time frame: 1 year
1 secondary outcome
The number and function of immune effector cells in treated patients
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 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.
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, Docetaxel, Dendritic cells, OK-432 in people with Head and Neck Cancer, run by University of Yamanashi at 1 site in Japan.
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 16 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 24 Aug 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hiroki Ishii, MD (+81-55-273-6769, ishiih@yamanashi.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and feasibility of chemo-immunotherapy (time frame: 1 year). 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 24 Aug 2011.