Randomized Phase II Trial Of Sequential ATRA Then IL-2 For Modulation Of Dendritic Cells And Treatment Of Metastatic Renal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Ratio of Dendritic Cells (DC) to Circulating Immature Cells (ImC) Before and After Treatment
研究概览
简要总结
RATIONALE: Tretinoin may help cells that are involved in the body's immune response to work better. Interleukin-2 may stimulate the white blood cells to kill kidney cancer cells. Giving tretinoin together with interleukin-2 may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving three different doses of tretinoin together with interleukin-2 works in treating patients with stage IV kidney cancer.
详细描述
OBJECTIVES:
Primary
- Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer.
- Assess in vitro immune response assays to tetanus toxoid and influenza virus peptide before and after treatment with tretinoin and interleukin-2 in these patients.
Secondary
- Determine the frequency of treatment-related side effects in these patients.
- Determine clinical objective response and progression-free survival of patients treated with this regimen.
- Correlate DC:ImC ratio with clinical objective response in patients treated with this regimen.
- Correlate the extent of change of the DC:ImC ratio with tretinoin dose and tretinoin blood levels in these patients.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
ATRA Followed by IL-2 - Dose Level A
Patients were assigned to one of three ATRA dose levels, at a 1:1:1 ratio, using a randomly permuted list assignments, with the assignment generally being made on the initial day of treatment.
Week 1: One dose daily of IL-2 for 5 days followed by 2 days off.
Weeks 2-6: One dose daily of IL-2 for 5 days followed by 2 days off.
After the IL-2: 2-3 weeks rest, with no treatment. During this time a repeat physical exam, history and X-ray scans will be performed. If there has not been progression (worsening) of the patient's tumor, they will continue to a second 8-week treatment schedule.
This schedule will be the same as the first, unless the patients dose had to be reduced. If so, patient's will get that reduced dose. It consists of 1 week of ATRA, 1 week of rest, followed by 6 weeks of IL-2. The same blood tests are collected during that second cycle.
干预措施: IL-2 (Drug)
ATRA Followed by IL-2 - Dose Level A
Patients were assigned to one of three ATRA dose levels, at a 1:1:1 ratio, using a randomly permuted list assignments, with the assignment generally being made on the initial day of treatment.
Week 1: One dose daily of IL-2 for 5 days followed by 2 days off.
Weeks 2-6: One dose daily of IL-2 for 5 days followed by 2 days off.
After the IL-2: 2-3 weeks rest, with no treatment. During this time a repeat physical exam, history and X-ray scans will be performed. If there has not been progression (worsening) of the patient's tumor, they will continue to a second 8-week treatment schedule.
This schedule will be the same as the first, unless the patients dose had to be reduced. If so, patient's will get that reduced dose. It consists of 1 week of ATRA, 1 week of rest, followed by 6 weeks of IL-2. The same blood tests are collected during that second cycle.
干预措施: ATRA (Drug)
ATRA Followed by IL-2 - Dose Level B
Patients were assigned to one of three ATRA dose levels, at a 1:1:1 ratio, using a randomly permuted list assignments, with the assignment generally being made on the initial day of treatment.
Week 1: One dose daily of IL-2 for 5 days followed by 2 days off.
Weeks 2-6: One dose daily of IL-2 for 5 days followed by 2 days off.
After the IL-2: 2-3 weeks rest, with no treatment. During this time a repeat physical exam, history and X-ray scans will be performed. If there has not been progression (worsening) of the patient's tumor, they will continue to a second 8-week treatment schedule.
This schedule will be the same as the first, unless the patients dose had to be reduced. If so, patient's will get that reduced dose. It consists of 1 week of ATRA, 1 week of rest, followed by 6 weeks of IL-2. The same blood tests are collected during that second cycle.
干预措施: IL-2 (Drug)
ATRA Followed by IL-2 - Dose Level B
Patients were assigned to one of three ATRA dose levels, at a 1:1:1 ratio, using a randomly permuted list assignments, with the assignment generally being made on the initial day of treatment.
Week 1: One dose daily of IL-2 for 5 days followed by 2 days off.
Weeks 2-6: One dose daily of IL-2 for 5 days followed by 2 days off.
After the IL-2: 2-3 weeks rest, with no treatment. During this time a repeat physical exam, history and X-ray scans will be performed. If there has not been progression (worsening) of the patient's tumor, they will continue to a second 8-week treatment schedule.
This schedule will be the same as the first, unless the patients dose had to be reduced. If so, patient's will get that reduced dose. It consists of 1 week of ATRA, 1 week of rest, followed by 6 weeks of IL-2. The same blood tests are collected during that second cycle.
干预措施: ATRA (Drug)
ATRA Followed by IL-2 - Level C
Patients were assigned to one of three ATRA dose levels, at a 1:1:1 ratio, using a randomly permuted list assignments, with the assignment generally being made on the initial day of treatment.
Week 1: One dose daily of IL-2 for 5 days followed by 2 days off.
Weeks 2-6: One dose daily of IL-2 for 5 days followed by 2 days off.
After the IL-2: 2-3 weeks rest, with no treatment. During this time a repeat physical exam, history and X-ray scans will be performed. If there has not been progression (worsening) of the patient's tumor, they will continue to a second 8-week treatment schedule.
This schedule will be the same as the first, unless the patients dose had to be reduced. If so, patient's will get that reduced dose. It consists of 1 week of ATRA, 1 week of rest, followed by 6 weeks of IL-2. The same blood tests are collected during that second cycle.
干预措施: IL-2 (Drug)
ATRA Followed by IL-2 - Level C
Patients were assigned to one of three ATRA dose levels, at a 1:1:1 ratio, using a randomly permuted list assignments, with the assignment generally being made on the initial day of treatment.
Week 1: One dose daily of IL-2 for 5 days followed by 2 days off.
Weeks 2-6: One dose daily of IL-2 for 5 days followed by 2 days off.
After the IL-2: 2-3 weeks rest, with no treatment. During this time a repeat physical exam, history and X-ray scans will be performed. If there has not been progression (worsening) of the patient's tumor, they will continue to a second 8-week treatment schedule.
This schedule will be the same as the first, unless the patients dose had to be reduced. If so, patient's will get that reduced dose. It consists of 1 week of ATRA, 1 week of rest, followed by 6 weeks of IL-2. The same blood tests are collected during that second cycle.
干预措施: ATRA (Drug)
结局指标
主要结局
Ratio of Dendritic Cells (DC) to Circulating Immature Cells (ImC) Before and After Treatment
时间窗: 1 year, 3 months
Determine the ratio of dendritic cells (DC) to circulating immature cells (ImC) before and after treatment with 3 different doses of tretinoin in patients with stage IV renal cell cancer.
次要结局
- Frequency of Treatment-Related Side Effects(1 year, 3 months)
- Overall Response Rate (ORR)(1 year, 3 months)