A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- feasibility of the combination of Rituximab with Gemcitabin/cisplatin in R/M HNSCC
研究概览
简要总结
Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of 6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the patients were middle age and the impact for economy and society was incredible. For recurrent or metastatic HNSCC, the average life span was around 4-6 months. Most patients just can receive chemotherapy. However the chemotherapy can't have any survival benefit. Recently a study showed the Cetuximab plus chemotherapy with cisplatin and 5-fluorouracil had survival benefit in the recurrent or metastatic HNSCC. However in Taiwan, the cetuximab can't be given by health insurance for the patients of the situation.
A lot of investigations recently showed the B lymphocytes got involvements in the squamous cell carcinoma carcinogenesis and tumor progression. In addition the B cell will influence the tumor associated macrophages and myeloid derived suppressor cells. Those immune cells could decrease the affect of chemotherapy and radiotherapy. Thus the B cell depletion has the possibility to develop a new treatment policy. Therefore investigators create a pilot clinical trial using Rituximab plus chemotherapy with cisplatin and gemcitabine for recurrent or metastatic HNSCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of head and neck.
- •Locoregional recurrence and/or metastases after primary curative local treatment and unsuitable for further radiotherapy and surgery; or primary distant metastases at diagnosis.
- •Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI)
- •Eastern Cooperative Oncology Group performance status ≤2;
- •Age between 20 and 65 years; and life expectancy of at least 12 weeks.
- •Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have relapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
- •Negative pregnancy test, Fertile patients must use effective contraception
- •No history of allergic reactions attributed to Rituximab/cisplatin/gemcitabine
- •Patient consent must be obtained
排除标准
- •Presence of central nervous system (CNS) metastases;
- •Presence of other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ prior to entry into the study
- •Presence of bone-only metastasis
- •The organ function measured within 14 days prior to study entry as defined below: White blood cell (WBC) less than 2,000/mm3, absolute neutrophil count (ANC) less than 1,500/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤60 ml/min (based upon urine collection);
- •Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
- •Documented hypersensitivity to platinum compounds or compounds of similar chemical or biologic composition
- •Pregnant or lactating women.
- •Under rituximab treatment or have ever received rituximab within six months.
- •Ongoing other concurrent investigational agents or anticancer therapy
研究组 & 干预措施
Rituximab plus chemotherapy
- Drug:Rituximab
- Drug:Cisplatin
- Drug:Gemcitabine
干预措施: Rituximab (Drug)
Rituximab plus chemotherapy
- Drug:Rituximab
- Drug:Cisplatin
- Drug:Gemcitabine
干预措施: Cisplatin (Drug)
Rituximab plus chemotherapy
- Drug:Rituximab
- Drug:Cisplatin
- Drug:Gemcitabine
干预措施: Gemcitabine (Drug)
结局指标
主要结局
feasibility of the combination of Rituximab with Gemcitabin/cisplatin in R/M HNSCC
时间窗: One week after Rituximab and chemotherapy administration.
Unexpected adverse event. An AE that is not listed in the drug's current labeling, or An AE that is more severe or more specific than indicated in the labeling.
次要结局
- progression survival(through study completion, an average of 6 months)
- Response rate(through study completion, an average of 1 years)
- Adverse event(through study completion, an average of 6 months)
研究者
Ching Yun Hsieh
attending physician
China Medical University Hospital