Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

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.

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<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:

1. Less than 20 years
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