Status:
UNKNOWN
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
Lead Sponsor:
University of Yamanashi
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief 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 an...
Eligibility Criteria
Inclusion
- 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:
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01149902
Start Date
July 1 2010
Last Update
August 24 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Umiversity of Yamanashi Hospital
Chūō, Yamanashi, Japan, 409-3898