- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00045695
Bortezomib in Treating Patients With Waldenstrom's Macroglobulinemia
A Phase II Study Of PS-341 (NSC 681239) In Patients With Untreated Or Relapsed Waldenstrom's Macroglobulinemia
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have untreated or relapsed Waldenstrom's macroglobulinemia.
연구 개요
상세 설명
OBJECTIVES:
- Determine the efficacy of bortezomib, in terms of response rate, in patients with previously untreated or relapsed Waldenstrom's macroglobulinemia.
- Determine the toxicity of this drug in these patients.
- Determine the time to progression, stable disease duration, and response duration in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 4 weeks. Patients with complete or partial response or stable disease are followed every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study within 1.5-2 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Illinois
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Hinsdale, Illinois, 미국, 60521
- Hinsdale Hematology Oncology Associates
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104-4283
- Abramson Cancer Center at the University of Pennsylvania
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Alberta
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Calgary, Alberta, 캐나다, T2N 4N2
- Tom Baker Cancer Centre - Calgary
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Edmonton, Alberta, 캐나다, T6G 1Z2
- Cross Cancer Institute
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Manitoba
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Winnipeg, Manitoba, 캐나다, R3E 0V9
- CancerCare Manitoba
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Nova Scotia
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Halifax, Nova Scotia, 캐나다, B3H 1V7
- Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
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Ontario
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Hamilton, Ontario, 캐나다, L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
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London, Ontario, 캐나다, N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
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Toronto, Ontario, 캐나다, M4N 3M5
- Toronto Sunnybrook Regional Cancer Centre
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal, Quebec, 캐나다, H1T 2M4
- Maisonneuve-Rosemont Hospital
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Saskatchewan
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Saskatoon, Saskatchewan, 캐나다, S7N 4H4
- Saskatoon Cancer Centre
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Diagnosis of Waldenstrom's macroglobulinemia confirmed by immunofixation or immunoelectrophoresis
- Newly diagnosed or untreated with IgM ≥ 20 g/L OR
- Previously treated with IgM ≥ 5 g/L
- Non-refractory, defined as no disease progression during prior therapy or within 4 weeks of the last dose of most recent prior therapy (12 weeks for rituximab)
Must have 1 or more of the following:
- Symptomatic lymphadenopathy
- Hepatomegaly and/or splenomegaly
- Anemia (i.e., hemoglobin < 11.0 g/dL)
- Hyperviscosity syndrome
- No other lymphoproliferative disease including transformed aggressive lymphoma
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- See Disease Characteristics
- Absolute granulocyte count ≥ 1,000/mm^3
- Platelet count ≥ 50,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST or ALT ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Other
- No uncontrolled bacterial, fungal, or viral infection
- No pre-existing sensory or motor neurotoxicity grade 2 or greater
- No other prior malignancy except adequately treated nonmelanoma skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively treated solid tumor for which patient has been disease free for at least 5 years
- No other serious illness or medical condition that would preclude study participation
- No unreasonable geographical limitations
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Chemotherapy
- See Disease Characteristics
- At least 12 weeks since prior rituximab (for patients who have progressed)
- At least 24 weeks since prior rituximab (for patients who have not progressed)
- No prior high-dose chemotherapy and stem cell transplantation
- No prior radioactive monoclonal antibodies
Chemotherapy
- See Disease Characteristics
- See Biologic therapy
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
No more than 2 prior chemotherapy regimens
- The same chemotherapy combination given for first-line and second-line therapy is considered 2 regimens
- Single-agent rituximab not considered 1 prior regimen
- No concurrent cytotoxic chemotherapy
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- At least 4 weeks since prior radiotherapy (except for low-dose, non- myelosuppressive radiotherapy) and recovered
- No prior radiotherapy to more than 25% of bone marrow
Surgery
- At least 4 weeks since prior major surgery
Other
- At least 4 weeks since prior plasmapheresis
- At least 4 weeks since prior investigational anticancer therapy
- No other concurrent investigational anticancer agents or therapies
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Response rate
기간: 4 years
|
To assess the efficacy (response rate) of PS-341 given as a bolus intravenous injection twice weekly for two out of every 3 weeks in the treatment of a population of patients with previously untreated or relapsed Waldenström's Macroglobulinemia
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4 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Toxicity
기간: 4 years
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To assess the toxicity of PS-341 in patients with Waldenström's Macroglobulinemia as well as time to progression, stable disease duration and, if responses are observed, response duration.
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4 years
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Cytogenetics and genome profiling
기간: 4 years
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To assess bone marrow and peripheral blood for cytogenetics and genome profiling by microarray in patients with Waldenstrom's macroglobulinemia.
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4 years
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공동 작업자 및 조사자
수사관
- 연구 의자: Christine I. Chen, MD, Princess Margaret Hospital, Canada
간행물 및 유용한 링크
일반 간행물
- Chen CI, Kouroukis CT, White D, Voralia M, Stadtmauer E, Stewart AK, Wright JJ, Powers J, Walsh W, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. Bortezomib is active in patients with untreated or relapsed Waldenstrom's macroglobulinemia: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2007 Apr 20;25(12):1570-5. doi: 10.1200/JCO.2006.07.8659. Epub 2007 Mar 12.
- Chen CI, White Darrell, Kouroukis TC, et al.: Antitumor activity of bortezomib (PS-341; Velcade) in a phase II study of patients with previously untreated or treated Waldenstrom's macroglobulinemia (WM). [Abstract] Blood 104 (11): A-3278, 2004.
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
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bortezomib에 대한 임상 시험
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Sun Yat-sen UniversityFudan University; West China Hospital; Peking University Cancer Hospital & Institute; Ruijin... 그리고 다른 협력자들알려지지 않은