- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00003666
Irofulven in Treating Patients With Relapsed or Refractory Non-small Cell Lung Cancer
Phase II Trial of 6-Hydroxymethylacylfulvene (HMAF; MGI-114) in Patients With Relapsed or Refractory Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irofulven in treating patients with relapsed or refractory non-small cell lung cancer.
연구 개요
상세 설명
OBJECTIVES: I. Determine the response rate to 6-hydroxymethylacylfulvene (HMAF) as salvage chemotherapy in patients with relapsed or refractory non-small cell lung cancer. II. Determine the duration of response to this regimen in this patient population. III. Determine the effect of prior response to chemotherapy on the response to HMAF in these patients. IV. Determine the survival and failure-free survival of patients treated with HMAF. V. Evaluate the toxicity profile of HMAF as salvage therapy in these patients.
OUTLINE: Patients are stratified into relapsed or refractory patient groups based on results achieved with prior therapy. Patients receive 6-hydroxymethylacylfulvene IV over 5 minutes daily for 5 days. Courses repeat every 28 days. Patients with stable or responding disease are treated for a minimum of 6 courses (2 courses beyond optimal response) in the absence of unacceptable toxic effects or disease progression. Patients are followed at least every 3 months for 1 year, then every 6 months until death.
PROJECTED ACCRUAL: A total of 66 patients (33 for each stratum) will be accrued for this study within 12-18 months.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Alabama
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Birmingham, Alabama, 미국, 35233
- Veterans Affairs Medical Center - Birmingham
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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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San Francisco, California, 미국, 94121
- Veterans Affairs Medical Center - San Francisco
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San Francisco, California, 미국, 94115-0128
- UCSF Cancer Center and Cancer Research Institute
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Delaware
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Wilmington, Delaware, 미국, 19899
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, 미국, 20307-5000
- Walter Reed Army Medical Center
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Washington, District of Columbia, 미국, 20007
- Vincent T. Lombardi Cancer Research Center, Georgetown University
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Florida
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Miami Beach, Florida, 미국, 33140
- CCOP - Mount Sinai Medical Center
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Illinois
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Chicago, Illinois, 미국, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, 미국, 60637
- University of Chicago Cancer Research Center
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Chicago, Illinois, 미국, 60612
- University of Illinois at Chicago Health Sciences Center
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Iowa
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Iowa City, Iowa, 미국, 52242
- University of Iowa Hospitals and Clinics
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Maine
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Togus, Maine, 미국, 04330
- Veterans Affairs Medical Center - Togus
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Maryland
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Baltimore, Maryland, 미국, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Dana-Farber Cancer Institute
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital Cancer Center
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Worcester, Massachusetts, 미국, 01655
- University of Massachusetts Memorial Medical Center
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Minnesota
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Minneapolis, Minnesota, 미국, 55417
- Veterans Affairs Medical Center - Minneapolis
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Missouri
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Columbia, Missouri, 미국, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, 미국, 65203
- Ellis Fischel Cancer Center - Columbia
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Saint Louis, Missouri, 미국, 63110
- Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, 미국, 68198-3330
- University of Nebraska Medical Center
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Omaha, Nebraska, 미국, 68105
- Veterans Affairs Medical Center - Omaha
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Nevada
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Las Vegas, Nevada, 미국, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Norris Cotton Cancer 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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Buffalo, New York, 미국, 14215
- Veterans Affairs Medical Center - Buffalo
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Manhasset, New York, 미국, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, 미국, 11030
- North Shore University Hospital
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New York, New York, 미국, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, 미국, 10021
- New York Presbyterian Hospital - Cornell Campus
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New York, New York, 미국, 10029
- Mount Sinai Medical Center, NY
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Syracuse, New York, 미국, 13210
- State University of New York - Upstate Medical University
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Syracuse, New York, 미국, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, 미국, 13210
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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North Carolina
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Chapel Hill, North Carolina, 미국, 27599-7295
- Lineberger Comprehensive Cancer Center, UNC
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Durham, North Carolina, 미국, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, 미국, 27710
- Duke Comprehensive Cancer Center
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Winston-Salem, North Carolina, 미국, 27104-4241
- CCOP - Southeast Cancer Control Consortium
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Winston-Salem, North Carolina, 미국, 27157-1082
- Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
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Ohio
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Columbus, Ohio, 미국, 43210
- Arthur G. James Cancer Hospital - Ohio State University
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Rhode Island
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Providence, Rhode Island, 미국, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, 미국, 29425-0721
- Medical University of South Carolina
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Tennessee
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Memphis, Tennessee, 미국, 38104
- Veterans Affairs Medical Center - Memphis
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Memphis, Tennessee, 미국, 38163
- University of Tennessee, Memphis Cancer Center
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Vermont
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White River Junction, Vermont, 미국, 05009
- Veterans Affairs Medical Center - White River Junction
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Virginia
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Richmond, Virginia, 미국, 23298-0037
- MBCCOP - Massey Cancer Center
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Richmond, Virginia, 미국, 23249
- Veterans Affairs Medical Center - Richmond
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Histologically or cytologically proven recurrent or refractory non-small cell lung cancer Squamous cell Adenocarcinoma (including bronchoalveolar cell) Large cell anaplastic (giant and clear cell carcinomas) Measurable disease (not bone disease only, pleural or pericardial effusions, or irradiated lesions, unless progression is documented after radiotherapy) No CNS metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater 1.5 mg/dL SGOT no greater than 2 times upper limit of normal (ULN) Renal: Creatinine no greater than ULN Cardiovascular: No active cardiac disease No unstable angina No myocardial infarction within 6 months No congestive heart failure No inability to tolerate hypotension Other: Not pregnant or nursing Fertile patients must use effective contraception HIV negative No uncontrolled diabetes mellitus No psychiatric disorders No concurrent secondary malignancies except nonmelanomatous skin cancer or patients with less than a 30% risk of relapse
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin) At least 1 prior chemotherapy agent or combination, including adjuvant or neoadjuvant therapy for non-small cell lung cancer No more than 1 prior chemotherapy agent or combination for metastatic or recurrent disease No prior HMAF No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy except for nondisease related conditions Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No concurrent palliative radiotherapy Surgery: Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: HMAF
treatment of refractory or relapsed NSCLC with HMAF
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11mg/sq m IV infusion over 5 min q day for 5 days each 28 day cycle
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Response
기간: ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression
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ea tx cycle; q 3 mon Yr 1 post tx, then q 6 mon until progression
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Toxicity
기간: Each tx cycle
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Each tx cycle
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공동 작업자 및 조사자
수사관
- 연구 의자: Carol A. Sherman, MD, Medical University of South Carolina
간행물 및 유용한 링크
일반 간행물
- Sherman CA, Herndon JE 2nd, Watson DM, Green MR; Cancer and Leukemia Group B. A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with relapsed or refractory non-small cell lung cancer. Lung Cancer. 2004 Sep;45(3):387-92. doi: 10.1016/j.lungcan.2004.02.017.
- Sherman CA, Herndon JE, Green MR, et al.: CALGB 39805: phase II trial of 6-hydroxymethylacylfulvene (HMAF; MGI-114) in patients with relapsed or refractory non-small cell lung cancer (NSCLC). [Abstract] Proceedings of the American Society of Clinical Oncology 19: A2163, 2000.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 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
- CALGB-39805
- U10CA031946 (미국 NIH 보조금/계약)
- CLB-39805
- CDR0000066761 (레지스트리 식별자: NCI Physician Data Query)
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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