Clinical trial · Interventional
Study of Chemo-Immunotherapy in Head and Neck Cancer Patients
Phase I Study of Chemo-Immunotherapy in Patients With Relapsed and Refractory Head and Neck Squamous Cell Carcinoma
NCT01149902CI-TRIAL-00005394unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide, Docetaxel, Dendritic cells, OK-432 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The safety and feasibility of chemo-immunotherapy
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- The number and function of immune effector cells in treated patients
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.