A Pilot Study of Neo-adjuvant Temsirolimus in Patients With Advanced Renal Cell Carcinoma Undergoing Definitive Therapy With Radical Nephrectomy, or Cytoreductive Nephrectomy: Analysis if Serum and Tissue Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- The rate of change in response of primary tumor and metastases (if applicable)in participants.
研究概览
简要总结
Temsirolimus is a drug that is being studied to possibly treat kidney cancer. It works by starving the cancer of nutrients, by cutting off the blood supply, which is hoping to shrink the cancer. This study will look at the experimental use of temsirolimus, 12 weeks prior to the surgical removal of the entire kidney or a portion of the kidney that is involved by the tumor.
详细描述
This study will also find out whether or not there are certain biological factors that show up in patients during their treatment with this drug. This will be able to predict how their disease will respond to the therapy (biomarkers), and this will possibly allow anti-cancer therapies to be developed in the future to tailor to a patient's needs.
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
- •At least 18 years old and capable of giving informed consent.
- •Patient has radiological evidence of RCC consisting of: CT scan with stage T2, T3, T3a, T4, or any stage T with N1/2 and/or metastatic disease.
- •Patient is already having a nephrectomy.
- •Adequate cardiac function as assessed by electrocardiogram (ECG).
- •Patient is will to have a kidney biopsy at baseline/screening.
- •Patient has scored a 0 or 1 on the ECOG.
- •Patient is negative for HIV, Hepatitis B, Hepatitis C
- •If patient is a woman of child-bearing potential, they have to have a negative pregnancy test.
排除标准
- •Patient has stage T1 disease without metastases.
- •Patient has abnormal laboratory values at screening within the following ranges:
- •Absolute neutrophil count ≤1.5 x 10(9)/L; Platelet count ≤ 100 x 10(9)/L
- •Leukocyte count ≤ 3 x 10(9)/L; Hemoglobin ≤ 80 g/L
- •Serum creatinine ≥ 2.0 x the upper normal limit (UNL)
- •Total bilirubin ≤ 1.5 x UNL; AST and ALT ≤ 3.0 x UNL
- •Fasting serum cholesterol ≤ 9.0 mmol/L
- •Fasting serum triglycerides ≤ 5.0 mmol/L
- •Patients with a known hyper-sensitivity to Temsirolimus.
- •Other currently active malignancies.
- •Currently taking any medications known to interfere with the metabolism of Temsirolimus.
- •Patients receiving anticoagulation with warfarin.
- •Patients with a history of pulmonary hypertension or interstitial lung disease.
- •Unstable angina as judged by the primary investigator, or any recent MI in the last 180 days.
研究组 & 干预措施
Temsirolimus (pre-surgery)
干预措施: Temsirolimus (pre surgery) (Drug)
结局指标
主要结局
The rate of change in response of primary tumor and metastases (if applicable)in participants.
时间窗: Baseline, Weeks 1-12, follow up every 3 months for years 1 and 2, and every 6 months for following three years (5 years in total).
Rate of Change in response of primary tumor and metastases (if applicable) to neo-adjuvant Temsirolimus in terms of tumour size and appearance (RECIST imaging response criteria) as determined by CT or MRI.
次要结局
- Quality of life data(Baseline, weekly visits, follow-up)
- Average time for disease progression.(At every visit; baseline, weekly visits, and follow-up.)
研究者
Anil Kapoor
MD, FRCSC
St. Joseph's Healthcare Hamilton