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Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

Primary Purpose

Head and Neck Cancer

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
Sponsored by
University of Yamanashi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Umiversity of Yamanashi HospitalRecruiting

Outcomes

Primary Outcome Measures

The safety and feasibility of chemo-immunotherapy

Secondary Outcome Measures

The number and function of immune effector cells in treated patients

Full Information

First Posted
June 22, 2010
Last Updated
August 23, 2011
Sponsor
University of Yamanashi
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1. Study Identification

Unique Protocol Identification Number
NCT01149902
Brief Title
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
Official Title
Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Yamanashi

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
Intervention Description
Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35
Primary Outcome Measure Information:
Title
The safety and feasibility of chemo-immunotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The number and function of immune effector cells in treated patients
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 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 signed informed consent 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hiroki Ishii, MD
Phone
+81-55-273-6769
Email
ishiih@yamanashi.ac.jp
Facility Information:
Facility Name
Umiversity of Yamanashi Hospital
City
Chuo
State/Province
Yamanashi
ZIP/Postal Code
409-3898
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroki Ishii, MD
Phone
+81-55-273-6769
Email
ishiih@yamanashi.ac.jp
First Name & Middle Initial & Last Name & Degree
Keisuke Masuyama, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

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