NCT00689195Unknown1 期
Evaluation of Curcumin Formulation, and Ashwagandha Root Powder Extract in the Management of Advanced High Grade Osteosarcoma"
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- response, toxicity, disease progression
研究概览
简要总结
Curcumin as well as the ashwagandha extract are ingredients from traditional indian medicine and have been shown to be potent anti-cancer compounds in laboratory as well as animal studies. This study will test the safety and efficacy of a curcumin formulation and the ashwagandha extract in high grade relapsed or metastatic osteosarcoma where no other second line chemotherapy is being given. The pharmacokinetics will be studied along with response as measured on CT scans and PET scans as well as the quality of life and any toxicity.
详细描述
Eligibility criteria
- Osteosarcoma which has relapsed after treatment and for which no second line chemotherapy is planned and in which disease is not amenable to surgery.
- Patient should be able to follow-up 3 monthly for clinical and imaging assessment as well as biochemical tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (between the ages of 8 to 65 years) with histologically proven high grade osteosarcoma of the extremity and relapsed disease after primary line of treatment who are unsuitable or refuse secondary chemotherapy.
- •Patients with advanced disease unable or unwilling to take primary conventional treatment
- •Patients with early or non-metastatic disease who are unable or unwilling to take the standard chemotherapy.
- •Adequate hepatic function defined by total bilirubin not more than 1.5 times the upper limit of normal (ULN) and SGOT and SGPT not more than 2.5 times the (ULN)
- •Adequate renal function defined by the creatinine clearance greater than 50 ml/min, calculated by cockcroft-Gault formula
排除标准
- •Patients who are suitable for second line chemotherapy and can afford it
- •Age less than 8 years or greater than 65 years
- •Pregnant or lactating women
- •Patients who are unable or unwilling to provide blood samples for the drug assays.
- •Low grade osteosarcoma
- •Patient requiring treatment with CYP3A4 inducers or inhibitors (patients on treatment for epilepsy or tuberculosis)
- •Participation in any investigational drug study within 28 days prior to study treatment.
研究组 & 干预措施
C
Experimental
Curcumin
干预措施: Curcumin powder (Dietary Supplement)
A
Experimental
Ashwagandha extract
干预措施: Ashwagandha extract (Dietary Supplement)
结局指标
主要结局
response, toxicity, disease progression
时间窗: 2 years
次要结局
- quality of life(2 years)
研究者
研究点 (1)
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