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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclophosphamide, Docetaxel, Dendritic cells, OK-432 | Biological | Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35 |
| Measure | Description | Time Frame |
|---|---|---|
| The safety and feasibility of chemo-immunotherapy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The number and function of immune effector cells in treated patients | 1 year |
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Inclusion Criteria:
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
Patients must have normal organ and marrow functions as follows:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hiroki Ishii, MD | Contact | +81-55-273-6769 | ishiih@yamanashi.ac.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Umiversity of Yamanashi Hospital | Recruiting | Chūō | Yamanashi | 409-3898 | Japan |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D010844 | Picibanil |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |