NCT00060255已完成2 期
Autologous Blood and Marrow Transplantation for Hematologic Malignancy and Selected Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 451
- 试验地点
- 2
- 主要终点
- Morbidity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •4 and over (patients 60 years of age and over are not eligible for TBI)
- •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
- •Bilirubin less than 3 times normal
- 另有 45 项未显示
排除标准
- 未提供
结局指标
主要结局
Morbidity
时间窗: +day 100
Mortality
时间窗: +day 100, +day 360
Overall outcome
时间窗: every 6 months until death
Response rate
时间窗: +day 100, +day 360
Toxicity
时间窗: +day100, +day 360
Disease-free survival
时间窗: up to 15years
Overall survival
时间窗: every 6 months until death
次要结局
未报告次要终点
研究者
研究点 (2)
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