Treatment of Advanced Head and Neck Cancer With Opioid Growth Factors: Phase II
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Progression of tumor measured with CT scan
研究概览
简要总结
This study will investigate the efficacy of opioid growth factor (OGF) on tumor size and survival in patients with head and neck cancer who have failed standard therapy.
详细描述
The major focus of the study will involve assessment of tumor response, patient survival, tolerance to drug, quality of life, depression, pain management and nutrition. During the study we will begin to study the kinetics of opioid growth factor (OGF) exogenous administration and the relationship between plasma OGF levels, stage of disease and length of treatment. Apart from potentially having growth inhibitory action on cancer, OGF may have some psychological and other biological effects which may prove to be beneficial in the patient's treatment. Presently there is no effective therapy or quality of life adjuvants for the 30,000 Americans who develop head and neck cancer yearly.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically and cytologically confirmed diagnosis of squamous cell carcinoma.
- •Patients not amenable to curative treatments with further surgery and/or radiation.
- •Patient has failed treatment with chemotherapy
- •Lesions must be distinct and the minimum measurements must be at least 2.0 cm x 2.0 cm at baseline.
- •Karnofsky performance rating of at lest 50%.
排除标准
- •Patients with severe and unstable cardiovascular disease.
- •Treatment naive subjects will not be included for study.
- •Patients with poorly controlled diabetes, seizure disorder, primary CNS tumors or known brain metastases will be excluded.
- •Pregnant or nursing women.
- •Patients requiring antibiotics in the preceding 2 weeks for a serious infection are not eligible.
- •Patients with a fever > 37.8 degrees C.
- •Pulse < 60 or > 110
- •Systolic blood pressure > 170 or less than 90 are not eligible.
- •Patients with nasopharyngeal squamous cell carcinoma will be excluded
- •Patients with hypercalcemia will be excluded from this study
结局指标
主要结局
Progression of tumor measured with CT scan
时间窗: every 3 months
次要结局
- Metastatic development using CT scan(every 3 months)
研究者
David Goldenberg
Associate Professor of Medicine and Surgery
Milton S. Hershey Medical Center