Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01149902
• Other study ID #: 631
• Status: Recruiting
• Phase: Phase 1
• First received: June 22, 2010
• Last updated: August 23, 2011
• Start date: July 2010

Study information

• Verified date: June 2010
• Source: University of Yamanashi
• Contact: Hiroki Ishii, MD
• Phone: +81-55-273-6769
• Email: ishiih[@]yamanashi.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Biological:
• Cyclophosphamide, 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

Locations

Country	Name	City	State
Japan	Umiversity of Yamanashi Hospital	Chuo	Yamanashi

Sponsors (1)

Lead Sponsor	Collaborator
University of Yamanashi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The safety and feasibility of chemo-immunotherapy		1 year	Yes
Secondary	The number and function of immune effector cells in treated patients		1 year	No