Trial of E10A in Head and Neck Cancer
关键词
抽象
日期
最后验证: | 06/30/2010 |
首次提交: | 03/04/2008 |
提交的预估入学人数: | 03/04/2008 |
首次发布: | 03/12/2008 |
上次提交的更新: | 07/25/2010 |
最近更新发布: | 07/27/2010 |
实际学习开始日期: | 02/29/2008 |
预计主要完成日期: | 11/30/2010 |
预计完成日期: | 11/30/2010 |
状况或疾病
干预/治疗
Drug: A
Drug: Cisplatin
Drug: Paclitaxel
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: A E10A combined with Cisplatin and Paclitaxel | Drug: A E10A 1*10(12)VP, intratumoral injection, d1 d8, repeat every 3 weeks for 4 cycles |
Active Comparator: B Cisplatin and Paclitaxel |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - histologically or cytologically confirmed recurrent or metastatic head and neck squamous carcinoma or nasopharyngeal carcinoma - the tumor was amenable to direct injection and measurement ( > 2 cm) - an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 - a life expectancy over three months - the absence of serious medical or psychiatric disorders - serum creatinine < 1.5 mg/dL; WBC count >3,000/mm3, platelet count > 80,000/mm3, hemoglobin > 8 g/dL; total bilirubin value < 1.5 times the upper limit of normal [ULN], ALT level < 2.5 times ULN, AST < 2.5 times ULN. Exclusion Criteria: - pregnant or breast feeding - a history of brain metastases or a primary brain tumor - a history of hemorrhagic diathesis - a history of corticosteroids or immunosuppressives use within four weeks of study entry - a history of immune deficiency disorder or organ transplant - has evidence of active adenovirus infection or uncontrolled infection - received any chemotherapy or radiotherapy within four weeks of study entry |
结果
主要结果指标
1. tumor response confirmed by CT or MRI [3 months]
次要成果指标
1. NCI toxicity criteria (CIC 3.0) [3 months]