Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

August 23, 2011 updated by: University of Yamanashi

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Yamanashi
      • Chuo, Yamanashi, Japan, 409-3898
        • Recruiting
        • Umiversity of Yamanashi Hospital
        • Contact:
        • Principal Investigator:
          • Keisuke Masuyama, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The safety and feasibility of chemo-immunotherapy
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
The number and function of immune effector cells in treated patients
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Yamanashi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Estimate)

August 24, 2011

Last Update Submitted That Met QC Criteria

August 23, 2011

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 631

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trials on Cyclophosphamide, Docetaxel, Dendritic cells, OK-432

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