- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00060255
High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation or autologous bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: This phase II trial is studying how well eight different high-dose chemotherapy regimens with or without total-body irradiation followed by autologous stem cell transplantation or autologous bone marrow transplantation works in treating patients with hematologic malignancies or solid tumors.
연구 개요
상태
상세 설명
OBJECTIVES:
- Determine the morbidity, mortality, and overall outcome in patients with hematologic malignancies, breast cancer, or other chemosensitive solid tumors treated with disease-specific dose-intensive conditioning regimens and autologous peripheral blood or bone marrow transplantation.
OUTLINE: Patients are stratified according to risk group (standard vs high). Standard risk includes acute leukemia in first relapse or second remission; lymphoma in responding first relapse or second remission; or breast cancer at risk for recurrence. High risk includes all others. Patients receive specific conditioning regimens according to diagnosis as outlined below.
Conditioning
- Regimen A (standard risk non-Hodgkin's lymphoma and under 60 years of age)-Etoposide, cyclophosphamide, and total body irradiation (TBI) (VCT): Patients receive etoposide IV continuously over 26 hours beginning on day -5 and cyclophosphamide IV over 2 hours on day -4. Patients undergo TBI on days -3 to -1.
- Regimen B (any risk Hodgkin's lymphoma and under 60 years of age)-Cyclophosphamide, carmustine, and etoposide (CBV): Patients receive etoposide IV continuously over 34 hours beginning on day -8; cyclophosphamide IV over 2 hours on days -7 to -4; and carmustine IV over 2 hours on day -3.
- Regimen C (any risk patient with prior exposure to high-dose etoposide and cyclophosphamide and under 60 years of age)-Melphalan and TBI (MEL/TBI): Patients receive melphalan IV over 30 minutes on day -4. Patients undergo TBI on days -3 to -1.
- Regimen D (multiple myeloma or amyloidosis)-Melphalan only (MEL only): Patients receive melphalan IV over 30 minutes on day -2.
- Regimen E (any patient unable to receive TBI)-Busulfan and cyclophosphamide: Patients receive oral busulfan (or busulfan IV over 2 hours) on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2.
- Regimen F (any risk breast cancer)-Cyclophosphamide, carboplatin, and thiotepa (STAMP V): Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24 hours, and thiotepa IV over 24 hours on days -7 to -4.
- Regimen G (solid tumors other than breast or testicular cancer)-Thiotepa and carboplatin (TT/CARBO): Patients receive thiotepa IV over 2 hours on days -6 and -5 and carboplatin IV continuously over 96 hours beginning on day -6.
- Regimen H (recurrent or primary progressive testicular cancer)-Etoposide and carboplatin (VP/CARBO): Patients receive etoposide IV over 2 hours and carboplatin IV over 30 minutes on days -6 to -4.
Stem Cell Infusion
- In all regimens, patients undergo autologous stem cell infusion on day 0. Treatment continues in the absence of unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 450 patients (50 patients [25 per stratum] per regimen) will be accrued for this study within 10 years.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
New York
-
Buffalo, New York, 미국, 14263-0001
- Roswell Park Cancer Institute
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
Histologically confirmed hematologic or solid tumor malignancy, including any of the following:
Acute myeloid leukemia
- First remission and not eligible for allogeneic transplantation; recurrent disease after combination chemotherapy with at least 1 standard regimen; or second remission
- Not eligible for protocol CLB-9620 or CLB-9621
Acute lymphoblastic leukemia
- First complete remission without appropriate allogeneic donor
Chronic myelogenous leukemia
- Chronic, accelerated, or blast phase
Lymphoproliferative diseases*
- Chronic lymphocytic leukemia
- Multiple myeloma
- Waldenstrom's macroglobulinemia
- Low-grade non-Hodgkin's lymphoma (NHL) NOTE: *Recurrent or persistent, symptomatic disease after first-line chemotherapy, or subsequently
Amyloidosis
- Primary or previously treated disease
NHL (intermediate- and high-grade)
- Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
First remission lymphoblastic or small, non-cleaved cell lymphoma at high risk of relapse
- CNS disease OR bone marrow disease and lactic dehydrogenase greater than 300 IU/L
Hodgkin's lymphoma
- Resistant or recurrent disease after combination chemotherapy with at least 1 standard regimen
Solid tumors
- High-risk and metastatic breast cancer
- Testicular cancer that has relapsed OR primary progressive disease that is responding to salvage therapy
- Other solid tumors that have recurred after conventional therapy OR are at high risk for relapse, and demonstrate chemosensitivity
- Less than 10% marrow tumor present histologically (maximum of 15% involvement allowed if purged)
Allogeneic marrow transplantation not possible or not desirable for any of the following reasons:
- Over 60 years of age
- No compatible donor identified
- Estimated risk of graft-versus-host disease complications greater than risk of recurrence after autologous bone marrow transplantation
- Patients with disease progression in a site of prior radiotherapy (4,000 cGy or more) are not eligible for total body irradiation (TBI) regimens
Hormone receptor status:
- Not specified NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS:
Age
- 4 and over (patients 60 years of age and over are not eligible for TBI)
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- More than 2 months
Hematopoietic
- WBC greater than 3,000/mm^3*
- Polymorphonuclear leukocyte count greater than 1,500/mm^3*
- Platelet count greater than 75,000/mm^3*
- Marrow cellularity greater than 20%*
- No marrow fibrosis* NOTE: *Before marrow storage
Hepatic
- Bilirubin less than 3 times normal
- Alkaline phosphatase less than 3 times normal
- AST less than 3 times normal
- Hepatitis status known
Renal
- Creatinine clearance at least 50 mL/min (not required for patients with amyloidosis or multiple myeloma)
Cardiovascular
- Ventricular ejection fraction at least 50% by radionuclide ventriculogram or echocardiogram
- No myocardial infarction within the past 6 months
- No congestive heart failure
- No symptomatic angina
- No life-threatening arrhythmia or hypertension
Pulmonary
- DLCO or DLVA at least 50% of predicted (DLCO must be corrected for hemoglobin and/or alveolar ventilation)
Other
- Not pregnant
- HIV negative
- Cytomegalovirus status known
- No active bacterial, viral, or fungal infection
- No active peptic ulcer disease
- No uncontrolled diabetes mellitus
- No serious organ dysfunction unless it is caused by the underlying disease
- No other serious medical or psychiatric illness that would preclude giving informed consent or complying with study requirements
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- See Disease Characteristics
- No prior cumulative nitrosourea dose greater than 600 mg/m^2
- No prior cumulative bleomycin dose greater than 150 units/m^2
- No prior cumulative doxorubicin dose greater than 450 mg/m^2
- No prior cumulative daunorubicin dose greater than 600 mg/m^2
- Patients with prior high-dose cyclophosphamide (greater than 150 mg/kg per cycle) and high-dose etoposide (greater than 2,400 mg/m^2 per cycle) are not eligible for the etoposide/cyclophosphamide/TBI conditioning regimen
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 3 weeks since prior radiotherapy (before blood stem cell harvest)
Prior cumulative doses of radiotherapy must not exceed the following:
- Spine/spinal cord: 4,000 cGy
- Mediastinum: 4,000 cGy
- Heart: 4,000 cGy
- Kidney (whole): 1,500 cGy
- Small bowel: 4,000 cGy
- Brain: 4,000 cGy
- Liver (whole): 2,000 cGy
- Lungs (whole): 1,500 cGy
- Bone: 5,000 cGy
Surgery
- Not specified
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Morbidity
기간: +day 100
|
+day 100
|
|
Mortality
기간: +day 100, +day 360
|
+day 100, +day 360
|
|
Overall outcome
기간: every 6 months until death
|
every 6 months until death
|
|
Response rate
기간: +day 100, +day 360
|
+day 100, +day 360
|
|
Toxicity
기간: +day100, +day 360
|
+day100, +day 360
|
|
Disease-free survival
기간: up to 15years
|
up to 15years
|
|
Overall survival
기간: every 6 months until death
|
every 6 months until death
|
공동 작업자 및 조사자
수사관
- 연구 의자: Philip L. McCarthy, MD, Roswell Park Cancer Institute
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
키워드
- 상세불명 소아 고형 종양, 프로토콜 특이적
- 4기 유방암
- IIIA기 유방암
- 재발성 유방암
- IIIB기 유방암
- 상세불명의 성인 고형 종양, 프로토콜 특이적
- 남성 유방암
- IIIC기 유방암
- 재발성 등급 3 여포성 림프종
- 재발성 성인 미만성 대세포 림프종
- 재발성 성인 면역모세포성 대세포 림프종
- 재발성 성인 버킷 림프종
- 재발성 소아기 소절단되지 않은 세포 림프종
- 재발성 소아 대세포 림프종
- 11q23(MLL) 이상이 있는 성인 급성 골수성 백혈병
- inv(16)(p13;q22)가 있는 성인 급성 골수성 백혈병
- t(15;17)(q22;q12)가 있는 성인 급성 골수성 백혈병
- t(16;16)(p13;q22)가 있는 성인 급성 골수성 백혈병
- t(8;21)(q22;q22)가 있는 성인 급성 골수성 백혈병
- 차도가 있는 소아 급성 림프구성 백혈병
- 완화된 소아 급성 골수성 백혈병
- 만성기 만성 골수성 백혈병
- 소아 만성 골수성 백혈병
- 원발성 전신성 아밀로이드증
- 재발성 성인 급성 골수성 백혈병
- 비정형 만성 골수성 백혈병
- 차도가 있는 성인 급성 골수성 백혈병
- 재발성 성인 호지킨 림프종
- 재발성/불응성 소아 호지킨 림프종
- 재발성 성인 미만성 소절단 세포 림프종
- 재발성 성인 미만성 혼합 세포 림프종
- 모세포기 만성 골수성 백혈병
- 발덴스트롬 마크로글로불린혈증
- 재발성 등급 1 여포성 림프종
- 재발성 등급 2 여포성 림프종
- 재발성 변연부 림프종
- 재발성 소림프구성 림프종
- 점막 관련 림프 조직의 결절외 변연부 B 세포 림프종
- 결절 변연부 B 세포 림프종
- 비장 변연부 림프종
- 재발성 맨틀 세포 림프종
- 난치성 만성 림프 구성 백혈병
- 불응성 다발성 골수종
- 가속기 만성 골수성 백혈병
- 차도가 있는 성인 급성 림프구성 백혈병
- 재발성 소아 급성 골수성 백혈병
- 재발성 소아 림프구성 림프종
- 재발성 악성 고환 생식 세포 종양
추가 관련 MeSH 약관
- 심혈관 질환
- 혈관 질환
- 피부병
- 면역계 질환
- 조직학적 유형에 따른 신생물
- 림프 증식 장애
- 림프계 질환
- 면역증식성 장애
- 부위별 신생물
- 혈액 질환
- 유방 질환
- 출혈성 장애
- 지혈 장애
- 파라단백혈증
- 혈액 단백질 장애
- 신생물
- 림프종
- 신생물, 생식 세포 및 배아
- 유방 신생물
- 다발성 골수종
- 신생물, 형질세포
- 백혈병
- 형질세포종
- 약물의 생리적 효과
- 약리작용의 분자기전
- 효소 억제제
- 항류마티스제
- 항종양제
- 면역억제제
- 면역학적 요인
- 항종양제, 알킬화제
- 알킬화제
- 골수 파괴 작용제
- 항종양제, 식물성
- 토포이소머라제 II 억제제
- 토포이소머라제 억제제
- 사이클로포스파마이드
- 카보플라틴
- 에토포사이드
- 멜파란
- 티오테파
- 부설판
- 카무스틴
기타 연구 ID 번호
- CDR0000301587
- RPCI-DS-9115
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. .