Tirapazamine Plus Cyclophosphamide in Treating Children With Refractory Solid Tumors
A Trial of Tirapazamine and Cyclophosphamide in Children With Refractory Solid Tumors
연구 개요
상세 설명
OBJECTIVES:
I. Determine the maximum tolerated dose and the dose limiting toxicity of tirapazamine when administered with cyclophosphamide as intravenous infusions to children with refractory solid tumors.
II. Determine the incidence and severity of other toxicities of tirapazamine and cyclophosphamide in these patients.
III. Determine a safe and tolerable dose of tirapazamine administered with cyclophosphamide for a phase II study for the same indications.
IV. Determine the pharmacokinetics of tirapazamine in children and adolescents receiving the combination of tirapazamine and cyclophosphamide.
V. Determine the preliminary evidence of antitumor activity of tirapazamine and cyclophosphamide.
OUTLINE: This is a dose escalation study.
Patients receive tirapazamine by 2 hour intravenous infusion (hours 0-2) followed 2 hours later by a 30 minute intravenous infusion of cyclophosphamide. This course is repeated every 3 weeks in patients with partial/complete response or stable disease for a maximum of 1 year. Cohorts of 3-6 patients each are treated at each dose level of tirapazamine. Dose escalation of tirapazamine occurs when 0 of 3 patients or 1 of 6 patients has experienced dose limiting toxicity (DLT). If DLT is experienced in 1 of 3 patients at a given dose level, up to 3 additional patients are treated at that same dose level. If none of the 3 additional patients at that dose level experiences DLT, the dose is escalated. If DLT is experienced in 1 or more of the additional 3 patients, the maximum tolerated dose (MTD) has been exceeded and 3 patients are treated at the next lower dose level (defined as the MTD). A total of six patients are treated at the MTD. If DLT is proved to be neutropenia, patients must then also meet the additional eligibility criteria listed for stratum 2. If neutropenia continues to be the DLT in stratum 2, then additional patients receive subcutaneous filgrastim (granulocyte colony-stimulating factor; G-CSF) beginning 24 hours after cyclophosphamide. A second MTD may be determined for chemotherapy with G-CSF. Patients are followed every 6 months for 4 years, and then annually thereafter.
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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Miami, Florida, 미국, 33136
- Sylvester Cancer Center, University of Miami
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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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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
- Floating Hospital for Children
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Michigan
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Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan
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Mississippi
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Jackson, Mississippi, 미국, 39216-4505
- University of Mississippi Medical Center
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Missouri
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Saint Louis, Missouri, 미국, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, 미국, 63104
- Cardinal Glennon Children's Hospital
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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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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, 75235-9154
- Simmons Cancer Center - Dallas
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Fort Worth, Texas, 미국, 76104
- Cook Children's Medical Center - Fort Worth
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Houston, Texas, 미국, 77030
- Baylor College of Medicine
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San Antonio, Texas, 미국, 78284
- 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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Ontario
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Toronto, Ontario, 캐나다, M5G 1X8
- Hospital for Sick Children
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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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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed solid tumor that is refractory to conventional therapy or for which no effective therapy is known
- Brain tumors eligible Brainstem gliomas may waive histological verification requirement
- Neurologic deficits associated with CNS malignancies must be stable for a minimum of 4 weeks prior to study
- No leukemia Stratum 2
- No marrow involvement
PATIENT CHARACTERISTICS:
- Age: 21 and under
- Performance status: Karnofsky or Lansky 50-100%
- Life expectancy: At least 8 weeks
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 75,000/mm3
- Hemoglobin at least 9 g/dL
- Bilirubin less than 1.5 mg/dL
- SGPT less than 5 times normal
- Creatinine normal for age OR creatinine clearance at least 70 mL/min
- Shortening fraction at least 27% of normal OR ejection fraction greater than 50% of normal
- Not pregnant or nursing
- Negative pregnancy test required
PRIOR CONCURRENT THERAPY:
- No concurrent anticancer therapy
- At least 6 months since bone marrow transplant and no evidence of graft versus host disease
- At least 1 week since growth factors
- No concurrent granulocyte colony-stimulating factor
- Recovered from prior immunotherapy
- Stratum 2: No prior bone marrow transplantation (with or without total body irradiation)
- At least 6 weeks since prior nitrosourea
- At least 2 weeks since other prior myelosuppressive chemotherapy
- Dexamethasone must be a stable or decreasing dose for 2 weeks prior to study
- Recovered from prior chemotherapy
- Stratum 2: No more than 2 prior chemotherapy regimens
- At least 2 weeks since local palliative radiotherapy (small port)
- At least 6 months since prior substantial bone marrow radiation (e.g., cross- sectional radiotherapy [greater than 24 Gy], total body irradiation, hemi- pelvic radiotherapy)
- Recovered from prior radiotherapy
- Stratum 2: No prior central axis radiation
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 |
|---|---|
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실험적: Arm I
See arm description.
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공동 작업자 및 조사자
수사관
- 연구 의자: Victor Aquino, MD, Simmons Cancer Center
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)
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추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- NCI-2012-01837
- POG-9675
- CDR0000066219 (레지스트리 식별자: PDQ (Physician Data Query))
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