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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01149902

Enrollment

Registered

2010-06-24

Start date

2010-07-31

Completion date

Unknown

Last updated

2011-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

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 and refractory head and neck squamous cell carcinoma.

Interventions

BIOLOGICALCyclophosphamide, 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The safety and feasibility of chemo-immunotherapy	1 year

Secondary

Measure	Time frame
The number and function of immune effector cells in treated patients	1 year

Countries

Japan

Contacts

Primary ContactHiroki Ishii, MD

ishiih@yamanashi.ac.jp+81-55-273-6769

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026