Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma

University of Yamanashi1 site in 1 country10 target enrollmentJuly 2010

ConditionsHead and Neck Cancer

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Head and Neck Cancer
Sponsor: University of Yamanashi
Enrollment: 10
Locations: 1
Primary Endpoint: The safety and feasibility of chemo-immunotherapy
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

March 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Yamanashi

Eligibility Criteria

Inclusion Criteria

•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
•WBC\>4000/mm3
•Platelet count\>100,000/mm3

Exclusion Criteria

•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