Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
研究概览
详细说明
OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.
OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.
PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
Ontario
-
Toronto、Ontario、加拿大、M5G 1X8
- Hospital for Sick Children
-
-
Quebec
-
Montreal、Quebec、加拿大、H3H 1P3
- Montreal Children's Hospital
-
Montreal、Quebec、加拿大、H3T 1C5
- Hôpital Sainte Justine
-
-
-
-
Victoria
-
Parkville、Victoria、澳大利亚、3052
- Royal Children's Hospital
-
-
Western Australia
-
Perth、Western Australia、澳大利亚、6001
- Princess Margaret Hospital for Children
-
-
-
-
Arkansas
-
Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
-
-
California
-
La Jolla、California、美国、92093-0658
- University of California San Diego Cancer Center
-
Los Angeles、California、美国、90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
-
Los Angeles、California、美国、91010
- Beckman Research Institute, City of Hope
-
Los Angeles、California、美国、90027-0700
- Children's Hospital Los Angeles
-
Orange、California、美国、92868
- Children's Hospital of Orange County
-
Palo Alto、California、美国、94304
- Lucile Packard Children's Hospital at Stanford
-
San Francisco、California、美国、94115-0128
- UCSF Cancer Center and Cancer Research Institute
-
-
District of Columbia
-
Washington、District of Columbia、美国、20010-2970
- Children's National Medical Center
-
-
Florida
-
Gainesville、Florida、美国、32610-100277
- Shands Hospital and Clinics, University of Florida
-
-
Georgia
-
Atlanta、Georgia、美国、30322
- Emory University Hospital - Atlanta
-
-
Illinois
-
Chicago、Illinois、美国、60614
- Children's Memorial Hospital, Chicago
-
-
Indiana
-
Indianapolis、Indiana、美国、46202-5265
- Indiana University Cancer Center
-
-
Maryland
-
Baltimore、Maryland、美国、21231
- Johns Hopkins Oncology Center
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
-
Boston、Massachusetts、美国、02111
- Boston Floating Hospital Infants and Children
-
-
Michigan
-
Ann Arbor、Michigan、美国、48109
- Mott Children's Hospital
-
Detroit、Michigan、美国、48201
- Children's Hospital of Michigan
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- Mayo Clinic Cancer Center
-
-
Mississippi
-
Jackson、Mississippi、美国、39216-4505
- University of Mississippi Medical Center
-
-
Missouri
-
Kansas City、Missouri、美国、64108
- Children's Mercy Hospital
-
Saint Louis、Missouri、美国、63104
- Cardinal Glennon Children's Hospital
-
-
New Jersey
-
Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
-
-
New York
-
Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
-
New York、New York、美国、10021
- Memorial Sloan-Kettering Cancer Center
-
New York、New York、美国、10032
- Columbia Presbyterian Hospital
-
Syracuse、New York、美国、13210
- State University of New York - Upstate Medical University
-
-
North Carolina
-
Durham、North Carolina、美国、27710
- Duke Comprehensive Cancer Center
-
-
Ohio
-
Cincinnati、Ohio、美国、45229-3039
- Children's Hospital Medical Center - Cincinnati
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- Children's Hospital of Philadelphia
-
Pittsburgh、Pennsylvania、美国、15213
- Children's Hospital of Pittsburgh
-
-
South Carolina
-
Charleston、South Carolina、美国、29425-0721
- Medical University of South Carolina
-
-
Tennessee
-
Memphis、Tennessee、美国、38105-2794
- Saint Jude Children's Research Hospital
-
Nashville、Tennessee、美国、37232-6838
- Vanderbilt Cancer Center
-
-
Texas
-
Fort Worth、Texas、美国、76104
- Cook Children's Medical Center - Fort Worth
-
Houston、Texas、美国、77030
- Baylor College of Medicine
-
Houston、Texas、美国、77030-4009
- University of Texas - MD Anderson Cancer Center
-
San Antonio、Texas、美国、78284-7811
- University of Texas Health Science Center at San Antonio
-
-
Utah
-
Salt Lake City、Utah、美国、84132
- Huntsman Cancer Institute
-
-
Washington
-
Seattle、Washington、美国、98105
- Children's Hospital and Regional Medical Center - Seattle
-
-
Wisconsin
-
Madison、Wisconsin、美国、53792-0001
- University of Wisconsin Hospital and Clinics
-
Milwaukee、Wisconsin、美国、53226
- Midwest Children's Cancer Center
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor at original diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor No bone marrow metastases (for less heavily pretreated stratum only)
PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky 50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater than grade II
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 1 week since prior growth factor therapy At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not specified Other: No concurrent foods or medication that interferes with P-450 metabolism Anticonvulsants allowed
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Therapy ECTEINASCIDIN 743 (1100 ug/m2 )
|
其他名称：
|
|
实验性的：ECTEINASCIDIN 743 (1300 ug/m2)
|
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
无进展生存期
大体时间：学习年限
|
学习年限
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Dose Limiting Toxicity
|
To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
|
|
|
Determine a safe and tolerable dose of vincristine, when administered with irinotecan
|
To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
|
|
|
Determine the pharmacokinetics of vincristine and irinotecan
大体时间：Length of study
|
To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
|
Length of study
|
|
Determine the incidence and severity of other toxicities
大体时间：Length of study
|
To determine the incidence and severity of other toxicities of this combination.
|
Length of study
|
|
Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine
大体时间：Length of study
|
To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
|
Length of study
|
合作者和调查者
调查人员
- 学习椅：Sylvain Baruchel, MD、The Hospital for Sick Children
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.