Phase I Study of Bioresponse-dim in Non-Metastatic, Hormone-Refractory Prostate Cancer Patients With Rising Serum PSA
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after
研究概览
简要总结
RATIONALE: Diindolylmethane may slow the growth of prostate cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of diindolylmethane in treating patients with nonmetastatic prostate cancer that has not responded to previous hormone therapy.
详细描述
OBJECTIVES:
Primary
- Establish the maximum tolerated dose, dose-limiting toxicity, and a recommended phase II dose of absorption-enhanced diindolylmethane (BioResponse-DIM^® [BR-DIM]) in patients with nonmetastatic, hormone-refractory prostate cancer and rising serum prostate-specific antigen (PSA) levels.
- Evaluate the toxicities of BR-DIM.
Secondary
- Evaluate the plasma pharmacokinetics of twice daily oral administration of BR-DIM in this patient population.
- Evaluate the effect of BR-DIM supplementation on serum PSA level.
- Correlate changes in expression levels of lymphocytes NF-kB with serum PSA levels in patients taking BR-DIM supplementation.
- Determine quality of life measures in patients taking BR-DIM supplementation.
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
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BR-DIM
BR-DIM will be administered at a starting dose of 75 mg po twice daily. Patients will be instructed to take tablets twice daily with 8 ozs. of water, with/without food. A study calendar will be provided and patients will be asked to fill the appropriate boxes when they take their study capsules. One treatment cycle is 28 days.
干预措施: BR-DIM (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD), Dose limiting toxicity (DLT) & toxicities during study and for 30 days after
时间窗: During study and for 30 days after
次要结局
- Plasma pharmacokinetics as measured by occurrences of toxicity(At baseline; Cycle 1 Day 1 at 20, 60, 120, 180, 240, and 480 minutes)
- Serum prostate specific antigen as measured by complete plasma concentration-time profile(At baseline, Day 1 of each cycle and at study termination)
- Correlate changes in expression levels of NF-kB lymphocytes in with serum prostate specific antigen levels by serum prostate specific antigen level(At baseline, Cycle 2 and study termination)
- Quality of life (QOL) by Life Orient. Test-Rev., Duke-UNC Func. Social Support Questionnaire, EORTC QOL questionnaire, QLQ-PR25 questionnaire, and the Hosp. Anxiety & Depression Scale(At baseline, day 1 of each cycle and study termination)
研究者
Elisabeth Heath
Principal Investigator
Barbara Ann Karmanos Cancer Institute