Topotecan in Treating Children With Refractory Leukemia
TOPOTECAN FOR CHILDREN WITH REFRACTORY LEUKEMIA, A PEDIATRIC ONCOLOGY GROUP PHASE I COOPERATIVE AGREEMENT STUDY
연구 개요
상세 설명
OBJECTIVES:
I. Describe the qualitative and quantitative toxic effects, including acute and chronic dose-limiting toxicity, cumulative toxicity, and time to recovery, in pediatric patients with refractory leukemia who are treated with a 30-minute daily infusion of topotecan (TOPO) for up to 12 consecutive days every 3 weeks.
II. Estimate the maximum tolerated dose of TOPO that results in tolerable, predictable, and reversible toxicity.
III. Determine the precautions and supportive therapy that should be used and the clinical and laboratory studies needed to monitor or alter therapy to prevent unacceptable toxicity in these patients.
IV. Observe any antileukemic effects that may occur during this phase I study in which duration of treatment is increased from 7 to 9 and then 12 days and TOPO doses are escalated.
V. Determine the recommended phase II pediatric dose of TOPO. VI. Characterize the pharmacokinetic parameters of TOPO and evaluate changes in these parameters with the first and last doses to determine whether there is drug accumulation.
VII. Correlate, if possible, these pharmacokinetic parameters with clinical response and toxicity.
OUTLINE:
Single-Agent Chemotherapy. Topotecan, TOPO, NSC-609699.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35294
- University of Alabama Comprehensive Cancer Center
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Arkansas
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Little Rock, Arkansas, 미국, 72205
- University of Arkansas for Medical Sciences
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California
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La Jolla, California, 미국, 92093-0658
- University of California San Diego Cancer Center
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Palo Alto, California, 미국, 94304
- Lucile Packard Children's Hospital at Stanford
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Florida
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Gainesville, Florida, 미국, 32610-100277
- Shands Hospital and Clinics, University of Florida
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Georgia
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Atlanta, Georgia, 미국, 30322
- Emory University Hospital - Atlanta
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Illinois
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Chicago, Illinois, 미국, 60614
- Children's Memorial Hospital, Chicago
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Kansas
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Kansas City, Kansas, 미국, 66160-7357
- University of Kansas Medical Center
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Wichita, Kansas, 미국, 67214
- Via Christi Regional Medical Center
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- MBCCOP - LSU Medical Center
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Maryland
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Baltimore, Maryland, 미국, 21287
- Johns Hopkins Oncology Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, 미국, 02111
- Boston Floating Hospital Infants and Children
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Michigan
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Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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New Jersey
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Hackensack, New Jersey, 미국, 07601
- Hackensack University Medical Center
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New York
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Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
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Syracuse, New York, 미국, 13210
- State University of New York - Upstate Medical University
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North Carolina
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Asheville, North Carolina, 미국, 28801
- Memorial Mission Hospital
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Tennessee
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Memphis, Tennessee, 미국, 38105-2794
- Saint Jude Children's Research Hospital
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Texas
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Dallas, Texas, 미국, 75230
- Medical City Dallas Hospital
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Dallas, Texas, 미국, 75235-9154
- Simmons Cancer Center - Dallas
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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Lackland Air Force Base, Texas, 미국, 78236-5300
- San Antonio Military Pediatric Cancer and Blood Disorders Center
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San Antonio, Texas, 미국, 78284-7811
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Milwaukee, Wisconsin, 미국, 53226
- Midwest Children's Cancer Center
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Geneva, 스위스, 1211
- Clinique de Pediatrie
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Quebec
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Montreal, Quebec, 캐나다, H3H 1P3
- Montreal Children's Hospital
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Montreal, Quebec, 캐나다, H3T 1C5
- Hôpital Sainte Justine
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San Juan, 푸에르토 리코, 00936-5067
- University of Puerto Rico School of Medicine Medical Sciences Campus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
-Histologically or cytologically confirmed leukemia refractory to conventional therapy or for which no effective curative therapy exists
PATIENT CHARACTERISTICS:
- Age: Under 21
- Performance status: ECOG 0-2
- Life expectancy: At least 8 weeks
- Adequate platelet count and hemoglobin required (transfusion allowed)
- Bilirubin no greater than 1.5 mg/dL
- AST or ALT no greater than 2 times normal
- Creatinine less than 1.5 mg/dL
- Adequate nutritional status, e.g. higher than third percentile weight for height
- Albumin at least 3 g/dL
- No severe uncontrolled infection
- No pregnant women
- Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY:
- At least 3 weeks since systemic chemotherapy (6 weeks since nitrosoureas)
- Recovered at least 3 months since bone marrow transplant (at least 6 months since total-body irradiation)
- No concurrent anticancer therapy
- No concurrent treatment studies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Arm I
Single-Agent Chemotherapy.
Topotecan, TOPO, NSC-609699.
|
공동 작업자 및 조사자
수사관
- 연구 의자: Wayne Lee Furman, MD, St. Jude Children's Research Hospital
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2012-01833
- POG-9575
- CDR0000064511 (레지스트리 식별자: PDQ (Physician Data Query))
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