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Trial Title:
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
NCT ID:
NCT01149902
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Cyclophosphamide
Docetaxel
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
Description:
Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432
5KE/day, day7,14,28,35
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. The patients with relapsed and refractory head and neck squamous cell carcinoma
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Umiversity of Yamanashi Hospital
Address:
City:
Chuo
Zip:
409-3898
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Hiroki Ishii, MD
Phone:
+81-55-273-6769
Email:
ishiih@yamanashi.ac.jp
Investigator:
Last name:
Keisuke Masuyama, MD, PhD
Email:
Principal Investigator
Start date:
July 2010
Lead sponsor:
Agency:
University of Yamanashi
Agency class:
Other
Source:
University of Yamanashi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01149902
