Gemcitabine and High-dose Chemotherapy Followed by Peripheral Blood Stem Cell Rescue for Relapsed or Resistant Hodgkin's Disease

Stanford University1 个研究点分布在 1 个国家目标入组 146 人开始时间: 2001年9月最近更新: 2017年6月14日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Stanford University
入组人数: 146
试验地点: 1
主要终点: Dose-limiting Toxicity of Gemcitabine Due to Non-hematologic Toxicity

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a phase 2 study of gemcitabine + high-dose chemotherapy followed by peripheral blood stem cell (PBSC) rescue for Hodgkin's Disease

详细描述

To assess the non-hematologic toxicity and determine the phase 2 dose of gemcitabine in combination with vinorelbine followed by carmustine, etoposide and cyclophosphamide and autologous hematopoietic stem cell transplantation [aka peripheral blood stem cell (PBSC)].

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: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically-proven recurrent or refractory Hodgkin's Disease (Hodgkin's lymphoma) on the basis of excisional biopsy whenever possible.
•Age < 70 years
•Eastern Cooperative Oncology Group (ECOG) performance status 0 to
•Phase 1 study component only: 1 or more of the following adverse risk factors
•Stage IV extranodal disease at relapse "B" symptoms
•Failure to achieve minimal disease with most recent chemotherapy (single lymph nodes < 2 cm or >75% reduction in a bulky tumor mass and bone marrow involvement < 10%)
•Progression during induction or salvage therapy
•Phase 2 study component only: No risk factor criteria
•Computerized tomography (CT) scan of the chest, abdomen and pelvis, with assessment of response to last chemotherapy, within 4 weeks of registration. Gallium scan or positron emission tomography (PET) scan confirmation of disease within 4 weeks of registration is highly recommended
•Bone marrow biopsy and cytogenetic analysis within 8 weeks of registration
•Women of child-bearing potential and sexually active males expected to use an accepted and effective method of birth control
•Pretreatment serum bilirubin < 2 x the institutional upper limit of normal (ULN) (within 28 days prior to registration)
•Serum creatinine < 2 x the institutional ULN (within 28 days prior to registration)
•Measured or estimated creatinine clearance > 60 cc/min by the following formula (within 28 days prior to registration):
•Estimated Creatinine Clearance = (140 age) x WT(kg) x 0.85 (if female) x creatinine (mg/dL)
•Electrocardiogram (ECG) demonstrating no significant abnormalities suggestive of active cardiac disease (within 42 days prior to registration)
•Patients over age 50, who have received chest irradiation or a total of 300 mg/m2 of doxorubicin or with any history of cardiac disease must have a radionuclide ejection fraction (within 42 days prior to registration). If the ejection fraction is 40 to 50%, the patient will have a cardiology consult
•Corrected diffusion capacity > 55%
•Written informed consent in accordance with institutional and federal guidelines

排除标准

•Positive HIV antibody test (must be conducted within 42 days of registration)
•No chemotherapy other than corticosteroids should be administered within 2 weeks of the initiation of protocol therapy
•Breast-feeding
•Requiring therapy for:
•Coronary artery disease
•Cardiomyopathy
•Dysrhythmia, or
•Congestive heart failure
•Over age 50 and has received chest irradiation or a total of 300 mg/m^2 of doxorubicin
•History of cardiac disease and the ejection fraction is < 40% (radionuclide ejection fraction must be within 42 days of registration)
•Known allergy to etoposide
•History of Grade 3 hemorrhagic cystitis with cyclophosphamide
•History of grade 2 or greater sensory or motor peripheral neuropathy due to prior vinca alkaloid use
•No prior malignancy (EXCEPTION: adequately treated basal cell or squamous cell skin cancer; in situ cervical cancer; or other cancer for which the patients has been disease-free for 5 years). Patients with a prior diagnosis of non-Hodgkin's lymphoma are not eligible.