Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

NCT01149902 | Unknown Phase 1

• 1 other identifier: 631
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• The safety and feasibility of chemo-immunotherapy

  1 year

Secondary Outcomes (1)

• The number and function of immune effector cells in treated patients

  1 year

Interventions

Cyclophosphamide, Docetaxel, Dendritic cells, OK-432 BIOLOGICAL

Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients with relapsed and refractory head and neck squamous cell carcinoma
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Yamanashi: lead

Study Sites (1)

Umiversity of Yamanashi Hospital

Chūō, Yamanashi, 409-3898, Japan

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Picibanil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Biological Products; Complex Mixtures

Central Study Contacts

Hiroki Ishii, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 24, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2012
• Last Updated: August 24, 2011

Record last verified: 2010-06

Locations

JP (1)