An Immunopharmacodynamic Phase 0/I Study of Rapamycin in Patients Undergoing Radical Cystectomy for Bladder Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Tissue pharmacodynamic (PD) response to TORC1 inhibition
研究概览
简要总结
This study aims to evaluate the effects of rapamycin directly on bladder tumors and the effects of rapamycin on the immune system of patients with bladder cancer.
详细描述
This is a presurgical clinical trial which aims to understand the biologic activity of TORC1 inhibition and safety in patients with bladder cancer. In this presurgical setting, paired PMBCs and tumor tissue is evaluated before and after exposure to rapamycin to address target specificity, drug delivery, physiologic effects on tumor growth and apoptosis, and correlation of biomarkers with clinical activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Have invasive (≥T1) bladder cancer
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •In their treating physician's opinion is a good candidate for radical cystectomy
- •In their treating physician's opinion does not need neoadjuvant chemotherapy prior to cystectomy
- •Be able to give informed consent
- •Be age 18 or older
- •Have adequate marrow function (defined as granulocytes greater than 1,500 cells/mm3 hemoglobin >9.5 gm/dl or platelets more than 100,000 cells/mm3).
- •Have adequate end-organ function (GFR >30, bilirubin <1.5, SGOT < 3x ULN)
- •Have a life expectancy > one year
- •Not have a prior history of non-bladder cancer unless the cancer is clinically stable and not requiring active treatment
- •Not have received chemotherapy or radiotherapy in the prior 30 days
排除标准
- •Immunosuppressed state (e.g. HIV, use of chronic steroids)
- •Fixed disease (clinical T4)
- •Active, uncontrolled infections
- •Hepatic impairment (SGOT >3x ULN)
- •Unhealed wounds
- •Patients at risk of pregnancy who are unwilling or unable to take effective contraception before rapamycin therapy, during therapy, and for 12 weeks after discontinuation of therapy.
研究组 & 干预措施
Rapamycin
Rapamycin 3mg orally daily x 4weeks prior to radical cystectomy
干预措施: Rapamycin (Drug)
结局指标
主要结局
Tissue pharmacodynamic (PD) response to TORC1 inhibition
时间窗: 30 days
PD response defined by significant phospho rpS6 Kinase 1 (S6K1) inhibition (comparing post-treatment to baseline).
次要结局
未报告次要终点
研究者
Robert Svatek
Assistant Professor, Division of Urologic Oncology
The University of Texas Health Science Center at San Antonio