NCT00504751已完成2 期
Phase II Trial of "VIPER" Chemotherapy in Relapsed and Refractory Diffuse Large B-cell Lymphoma (NHL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Complete Response
研究概览
简要总结
Objectives
The primary objective of this study is to:
• determine the complete and partial response rates and the toxicity profile of bortezomib (VELCADE, formerly PS-341) when administered in combination with DICE chemotherapy plus rituximab (i.e. VIPER) to patients with relapsed or refractory diffuse large B-cell non-Hodgkin's lymphoma
The secondary objectives of this study are to:
- assess event free survival and overall survival
- assess conversion of chemo-resistant to chemo-sensitive disease
- assess the ability to collect stem cells from patients treated with salvage VIPER who then undergo autologous stem cell transplantation
- perform correlative studies on pre-treatment tumor biopsy specimens; analyses will include the assessment of immunohistochemical expression patterns (germinal center B cell vs. activated B cell) and NF-κB activity
详细描述
Single arm phase II trial of combination therapy bortezomib, DICE, and Rituximab in patients with relapsed and refractory diffuse large B-cell non-Hodgkin's lymphoma (NHL)
VIPER chemotherapy will be administered every 28 days at the following doses:
- Dexamethasone 40 mg IV days 1-4
- Ifosfamide 1.0 gram/m2 CIVI over 24 hours days 1-4
- Mesna 1.0 gram/m2 CIVI over 24 hours days 1-4 (mix solution with ifosfamide)
- Cisplatin 25 mg IV days 1-4
- Etoposide 100 mg/m2 CIVI over 24 hours days 1-4
- Rituximab 500 mg/m2 IV day 1 prior to start of DICE (375 mg/m2 for subsequent cycles)
- VELCADE 1.5 mg/m2 on days 2 and 5
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of CD20 positive, diffuse large B-cell NHL; de novo or transformed histologies are acceptable
- •Patient must have relapsed after or not responded to at least one standard, upfront multi-agent chemotherapy for DLBCL
- •Measurable PET positive disease, as defined by tumor mass > 1.5 cm in one dimension
- •Stage II, III, or IV disease
- •Age > 18 years
- •Adequate liver and kidney function (total bilirubin < 2 x ULN and creatinine < 2.0 mg/dl, unless abnormalities are related to lymphoma or Gilbert's disease
- •Adequate bone marrow reserves (absolute neutrophil count >1500 cells/mm3 and platelet count > 100,000, unless cytopenias are the result of marrow infiltration by lymphoma
- •ECOG performance status < 2
- •Life expectancy of at least 3 months
- •Bortezomib-naive
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- •Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.
- •Male subject agrees to use an acceptable method for contraception for the duration of the study.
排除标准
- •Patient has ≥ Grade 2 peripheral neuropathy within 14 days before enrollment.
- •Myocardial infarction within 6 months prior to enrollment or has New York Heart Association (NYHA) Class III or IV heart failure (see section 8.4), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant.
- •Patient has hypersensitivity to boron or mannitol
- •Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test result obtained during screening. (Pregnancy testing is not required for post-menopausal or surgically sterilized women)
- •Patient has received other investigational drugs or cytotoxic chemotherapy within 14 days of enrollment
- •Serious medical or psychiatric illness likely to interfere with participation in this clinical study
- •Known HIV infection
- •Active Hepatitis B or C as defined by positive Hepatitis B surface antigen or hepatitis C RNA
- •Known CNS disease
- •Pregnant or nursing women
- •Concurrent treatment with other chemotherapy or anti-lymphoma therapy, including corticosteroids, unless on a stable dose of corticosteroids less than the equivalent of 20 mg of prednisone each day for treatment of disease not related to lymphoma
- •Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- •Any condition that, in the opinion of the investigator, would prevent the subject from being fully compliant with the protocol.
研究组 & 干预措施
Study Treatment
Experimental
This is a single arm study
干预措施: bortezomib, dexamethasone, ifosfamide (Drug)
Study Treatment
Experimental
This is a single arm study
干预措施: mesna, cisplatin, etoposide, rituximab (Drug)
结局指标
主要结局
Complete Response
时间窗: 26 months
Complete Response
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Curative Resectability of Not Optimally Resectable Liver and/or Lung Metastases From Colorectal Carcinoma (CRC) Under Intensified ChemotherapyColorectal CarcinomaNCT01126866National Center for Tumor Diseases, Heidelberg35
招募中
2 期
Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic CancerLocally Advanced Pancreatic AdenocarcinomaNCT04570943Institut du Cancer de Montpellier - Val d'Aurelle103
Unknown
2 期
Efficacy of Pegylated Interferon Plus Ribavirin Plus Nitazoxanide in HCV Genotype 4 and HIV CoinfectionHCV CoinfectionHIV InfectionNCT01529073Juan Macías45
招募中
不适用
Chemotherapy and Pelvic Hypofractionated Radiation Followed by Brachytherapy for Cervical CancerCervical CancerNCT04070976National Institute of Cancerología82
已完成
2 期
Modified Hyper-CVAD (Cyclophosphamide, Vincristine, Adriamycin, and Dexamethasone) Program for Acute Lymphoblastic LeukemiaLeukemiaAcute Lymphoblastic LeukemiaNCT00671658M.D. Anderson Cancer Center220