Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
NCT ID: NCT01149902
Last Updated: 2011-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
10 participants
INTERVENTIONAL
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35
Eligibility Criteria
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Inclusion Criteria
2. 20 years and older
3. ECOG performance status 0-1
4. More than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy
5. Tumor lesions are accessible to intratumoral dendritic cells injection
6. Patients who are able to do oral ingestion
7. 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
8. signed informed consent
Exclusion Criteria
2. Patients who test positive for Hepatitis B virus, Hepatitis C virus or HIV.
3. Patients with clinically active infection
4. Patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency
5. Concomitant malignant diseases, brain metastases
6. Psychiatric illness
7. Treatment with steroids
8. Decision of unsuitableness by physician
20 Years
ALL
No
Sponsors
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University of Yamanashi
OTHER
Responsible Party
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Department of Otolaryngology-Head and Neck Surgery, University of Yamanashi, Faculty of Medicine
Locations
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Umiversity of Yamanashi Hospital
Chūō, Yamanashi, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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631
Identifier Type: -
Identifier Source: org_study_id
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