NCT00093704终止1 期
EBV as Therapeutic Target: A Pilot Study of Inducing and Targeting EBV-TK in EBV-Positive Lymphomas by Combination of Bortezomib and Ganciclovir
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas
研究概览
简要总结
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for their growth. The Epstein Barr virus can cause cancer and lymphoproliferative disorders. Ganciclovir is an antiviral drug that acts against the Epstein Barr virus. Giving ganciclovir together with bortezomib may kill more Epstein Barr virus-infected cancer cells.
PURPOSE: This clinical trial is studying how well giving bortezomib together with ganciclovir works in treating patients with relapsed or refractory Epstein Barr virus-positive lymphoma.
详细描述
OBJECTIVES:
Primary
- Maximum Tolerated Dose (MTD) of bortezomib in patients with relapsed or refractory Epstein Barr virus-positive lymphoma.
Secondary
- Assess the antitumor effect of this regimen in these patients.
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 Epstein Barr virus-positive lymphoma, including the following subtypes:
- •Post-transplantation lymphoma
- •Burkitt's lymphoma
- •Hodgkin's lymphoma
- •T-/NK-cell lymphoma
- •Unresponsive to, or relapsed after, at least 1 prior chemotherapy regimen
- •Bidimensionally measurable disease by CT scan
- •At least 1 lesion ≥ 1.5 cm in the greatest diameter
- •Age 18 and over
- •ECOG 0-2 OR
- •Karnofsky 50-100%
- •Life expectancy More than 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,000/mm^3 (no growth factor support within the past 4 weeks)
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 50,000/mm^3 (no platelet transfusions within the past 4 weeks)
- •Bilirubin ≤ 2.0 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN (5 times ULN in patients with liver involvement)
- •No active hepatitis B or C
- •Creatinine clearance ≥ 60 mL/min
- •Sodium > 130 mmol/L
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •At least 4 weeks since prior immunotherapy
- •At least 4 weeks since prior chemotherapy
- •At least 4 weeks since prior radiotherapy
- •More than 4 weeks since prior major surgery unless fully recovered
- •Recovered from all prior therapy
- •At least 4 weeks since prior investigational agents
排除标准
- •primary or secondary CNS lymphoma or HIV-related lymphoma
- •known brain metastases
- •myocardial infarction within the past 6 months
- •acute ischemia or new conduction system abnormalities by electrocardiogram
- •symptomatic congestive heart failure
- •unstable angina pectoris
- •cardiac arrhythmia
- •hospitalized
- •pregnant or nursing
- •other uncontrolled illness
- •ongoing or active systemic infection
- •psychiatric illness or social situation that would preclude study compliance
- •history of allergic reaction attributable to compounds of similar chemical or biological composition to study drugs
- •sensitivity to boron, mannitol, bortezomib, or ganciclovir
- •concurrent corticosteroids (≥ 10 mg of prednisone or equivalent)
- •concurrent radiotherapy
- •other concurrent anticancer therapy
- •other concurrent investigational agents
研究组 & 干预措施
Bortezomib + ganciclovir
Experimental
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8 and 11. Patients also receive ganciclovir IV twice daily on days 1-14. Treatment repeats every 21 days for a maximum of 3 courses.
干预措施: bortezomib + ganciclovir (Drug)
结局指标
主要结局
MTD of Bortezomib in patients with relapsed or refractory EBV + lymphomas
时间窗: 3 weeks
次要结局
- Bortezomib in inducing lytic gene expression in EBV-infected lymphoma cells(3 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Bortezomib, Ifosfamide, Carboplatin, and Etoposide, With or Without Rituximab, in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin LymphomaLymphomaNCT00598169AIDS Malignancy Consortium23
已完成
2 期
Bortezomib, Combination Chemotherapy, and Rituximab as First-Line Therapy in Treating Patients With Stage III or Stage IV Follicular Non-Hodgkin's LymphomaLymphomaNCT00428142NCIC Clinical Trials Group95
撤回
1 期
Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple MyelomaMultiple Myeloma and Plasma Cell NeoplasmNCT00504101University of Miami
已完成
1 期
Bortezomib, Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant For High-Risk Stage I or II Multiple MyelomaAutologous Hematopoietic Stem Cell Transplant RecipientLoss of Chromosome 17pRecurrent Plasma Cell MyelomaRefractory Plasma Cell MyelomaPlasma Cell LeukemiaNCT01163357City of Hope Medical Center18
已完成
2 期
Bortezomib in Treating Patients With Metastatic Kidney CancerKidney CancerNCT00276614Jonsson Comprehensive Cancer Center4