NCT00077285进行中（未招募）2 期
A Pilot Phase II Trial Of Irinotecan Plus Carboplatin, And Irinotecan Maintenance Therapy (High-Risk Patients Only), Integrated Into The Upfront Therapy Of Newly Diagnosed Patients With Intermediate - And High-Risk Rhabdomyosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin as upfront window therapy (first-line therapy) works in treating patients with newly diagnosed intermediate-risk or high-risk rhabdomyosarcoma.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with newly diagnosed intermediate- or high-risk rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and carboplatin.
- Determine the acute toxic effects of this regimen combined with radiotherapy in these patients.
- Determine the safety and feasibility of this regimen in these patients.
- Determine the rate of local control achieved in patients treated with this regimen in combination with intensity-modulated radiotherapy.
- Determine the safety and feasibility of administering maintenance therapy comprising irinotecan to patients with high-risk rhabdomyosarcoma treated with this regimen.
Secondary
- Correlate, preliminarily, in vitro measurements of angiogenesis with clinical features (extent of disease), response to therapy, and outcome in patients treated with this regimen.
- Determine, preliminarily, the efficacy of this regimen, in terms of improved outcomes, in these patients.
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
- — 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed, previously untreated histologically-proven rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma. Histology must be confirmed by a MSKCC pathologist.
- •Intermediate- or high-risk features as defined below:
- •All patients with Stage 4 tumors (distant metastases).
- •Intermediate Risk:
- •All patients with non-metastatic undifferentiated sarcoma or alveolar RMS or ectomesenchymoma with alveolar features (regardless of age, site, size, stage, or degree of initial surgical resection);
- •All patients < 1 year of age with non-metastatic embryonal RMS or ectomesenchymoma with embryonal features (regardless of site, stage, or degree of initial surgical resection).
- •Patients ≥ 1 year of age with Stage 2 or 3 (unfavorable site [see Appendix I] and either size > 5 cm, OR regional nodes positive, or both), Group III (gross residual disease post-biopsy or attempted resection) embryonal RMS or ectomesenchymoma with embryonal features
- •Age: ≤ 50 years (inclusive) at the time of diagnosis.
- •Biopsy or definitive surgery within 42 days of start of treatment.
- •Organ function:
- •Normal renal function: Normal serum creatinine for age or creatinine clearance or nuclear GFR of ≥ 80 ml/min/1.73m2 (in the absence of obstructive hydronephrosis, e.g., from pelvic or bladder/prostate tumor).
- •Normal liver function: Total bilirubin, SGOT/SGPT < 2.5 times the upper limit of normal (in the absence of hepatic involvement by tumor)
- •Normal cardiac function: echocardiogram shortening fraction ≥ 28% or resting left ventricular ejection fraction (LVEF) ≥ 50% on Technetium-99m pertechnetate radionuclide cineangiography (MUGA)
- •Normal hematologic function: absolute neutrophil count (ANC) ≥ 1500/μL, hemoglobin ≥ 9 gm/dL, and platelet count ≥ 100,000/μL (in the absence of bone marrow infiltration by tumor or the presence of disseminated intravascular coagulation).
- •Measurable disease is not required.
- •Patients must consent to an indwelling central venous catheter.
- •Sexually active patients of childbearing potential must be willing to use an effective method of contraception.
- •Patient or guardian must be capable of providing informed consent.
排除标准
- •Prior chemotherapy or radiotherapy (other than limited, emergent radiotherapy for treatment of threatened airway or cord compromise).
- •Pregnant or breast feeding females because the chemotherapy administered on this trial could have a detrimental effect on the developing fetus or newborn.
研究组 & 干预措施
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: dexrazoxane hydrochloride (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: carboplatin (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: doxorubicin hydrochloride (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: cyclophosphamide (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: radiation therapy (Radiation)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: conventional surgery (Procedure)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: vincristine sulfate (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: filgrastim (Biological)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: etoposide (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: ifosfamide (Drug)
pts with intermediate- and high-risk rhabdomyosarcoma
Experimental
干预措施: irinotecan hydrochloride (Drug)
结局指标
主要结局
Response rate
时间窗: 2 years
Rate of local control
时间窗: 2 years
Toxicity
时间窗: 2 years
Safety and feasibility
时间窗: 2 years
次要结局
- Correlation of in vitro measurements of angiogenesis with clinical features (extent of disease), response to therapy, and outcome(2 years)
- Efficacy in terms of improved outcomes(2 years)
研究者
研究点 (2)
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