To hear about similar clinical trials, please enter your email below

Trial Title: Study of Chemo-Immunotherapy in Head and Neck Cancer Patients

NCT ID: NCT01149902

Condition: Head and Neck Cancer

Conditions: Official terms:
Head and Neck Neoplasms
Cyclophosphamide
Docetaxel

Study type: Interventional

Study phase: Phase 1

Overall status: Unknown status

Study design:

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Cyclophosphamide, Docetaxel, Dendritic cells, OK-432
Description: Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Umiversity of Yamanashi Hospital

Address:
City: Chuo
Zip: 409-3898
Country: Japan

Status: Recruiting

Contact:
Last name: Hiroki Ishii, MD

Phone: +81-55-273-6769
Email: ishiih@yamanashi.ac.jp

Investigator:
Last name: Keisuke Masuyama, MD, PhD
Email: Principal Investigator

Start date: July 2010

Lead sponsor:
Agency: University of Yamanashi
Agency class: Other

Source: University of Yamanashi

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01149902

Login to your account

Did you forget your password?