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


Phase 1
20 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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
- GPT
- 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The safety and feasibility of chemo-immunotherapy

Outcome Time Frame:

1 year

Safety Issue:

Yes

Authority:

Japan: Institutional Review Board

Study ID:

631

NCT ID:

NCT01149902

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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