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Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
Type: Biological
Overall Status
Recruiting
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
- GPT
- 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
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
- GPT
- 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
Location
Umiversity of Yamanashi Hospital
Chuo, Yamanashi, Japan
Status: Recruiting
Contact: Hiroki Ishii, MD - +81-55-273-6769 - ishiih@yamanashi.ac.jp
Start Date
July 2010
Sponsors
University of Yamanashi
Source
University of Yamanashi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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