NCT00310128撤回2 期
Phase II Study of Induction Therapy Comprising Etoposide, Methylprednisolone, Cytarabine, and Cisplatin (ESHAP) Followed by Consolidation Therapy Comprising Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma
AIDS Malignancy Consortium0 个研究点开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving more than one drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
Primary
- Determine the overall survival rate at one year in patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma treated with consolidation therapy comprising rituximab and yttrium Y 90 ibritumomab tiuxetan (radioimmunotherapy) given after induction therapy comprising etoposide, methylprednisolone, cytarabine, and cisplatin (ESHAP).
- Describe the toxicity profile of radioimmunotherapy as consolidation therapy, including changes in immunologic and virologic parameters over time, in these patients.
- Determine the overall disease-free survival of patients receiving ESHAP as induction therapy followed by radioimmunotherapy as consolidation therapy.
Secondary
- Determine the effect of ESHAP as induction therapy and radioimmunotherapy as consolidation therapy on HIV-1 viral load, CD4 and CD8 cells, and quantitative immunoglobulin levels in patients on concurrent highly active antiretroviral therapy (HAART).
- Determine the objective response rates (complete and partial response) in patients treated with this regimen.
- Determine the toxicity of ESHAP as induction therapy in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically documented B-cell non-Hodgkin's lymphoma, including any of the following histologic types:
- •Follicular large B-cell lymphoma (follicular, grade 3)
- •Follicular mixed cell lymphoma (follicular, grade 2)
- •Diffuse mixed cell lymphoma
- •Diffuse large B-cell lymphoma
- •Immunoblastic lymphoma
- •Burkitt or Burkitt-like lymphoma
- •Anaplastic large cell lymphoma
- •Primary effusion lymphoma
- •All stages eligible
- •Seropositive for HIV by any approved test or positive HIV-1 RNA in plasma at anytime in the past
- •Prior documentation of HIV seropositivity allowed
- •Received 1 prior anthracycline-based regimen of curative intent
- •No more than 1 prior regimen
- •Measurable or evaluable disease
- •Evaluable disease defined as not having bidimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests, such as gallium scan, positron emission tomography (PET) imaging and/or bone marrow biopsy
- •No primary CNS lymphoma
- •Lymphomatous meningitis or brain metastasis eligible provided other measurable systemic lymphomatous disease is also present
- •Less than 25% bone marrow involvement with lymphoma
- •Concurrent effective highly active anti-retroviral therapy (HAART) required at study entry
- •HIV viral load < 100,000 copies/mL if HAART was not used previously
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status 50-100%
- •Bilirubin ≤ 2.0 mg/dL (unless elevated due to lymphomatous involvement of the liver or biliary tract OR due to other HIV medications [e.g., indinavir or atazanavir])
- •Creatinine < 2.0 mg/dL (< 2.6 mg/dL if due to use of tenofovir or truvada) OR creatinine clearance ≥ 60 mL/min
- •Granulocyte count > 1,000/mm^3 (unless abnormal due to lymphomatous involvement of the bone marrow)
- •Platelet count > 75,000/mm^3 (unless abnormal due to lymphomatous involvement of the bone marrow or HIV-related thrombocytopenia)
- •No acute intercurrent infection that may interfere with study participation
- •Mycobacterium avium allowed
- •No second active tumor except nonmelanomatous skin cancer, carcinoma in situ of the cervix, or Kaposi's sarcoma not requiring systemic chemotherapy
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- •No serious, ongoing nonmalignant disease or infection that would compromise study objectives
- •No antimurine antibody (HAMA) reactivity
- •No history of any cutaneous or mucocutaneous reaction from prior rituximab administration
- •No history of cutaneous or mucocutaneous reactions or diseases severe enough to cause hospitalization or an inability to eat for ≥ 2 days
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Fully recovered from all toxicities associated with prior surgery, radiotherapy, chemotherapy, or immunotherapy
- •Prior chronic therapy with potentially myelosuppressive agents allowed provided hematologic criteria are met at study entry
- •No radiotherapy within the past 4 weeks, unless for emergency conditions secondary to lymphoma (i.e., cord compression)
- •No anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C)
- •No rituximab within 6 weeks before study radioimmunotherapy
- •No investigational agent(s) within the past 4 weeks, unless these are antiretroviral agents available on a compassionate use basis
- •No prior external beam radiotherapy to > 25% of active bone marrow (involved field or regional)
- •No major surgery, other than diagnostic surgery, within the past 4 weeks
- •No prior myeloablative therapies with autologous bone marrow transplantation, peripheral blood stem cell rescue, or failed stem cell collection
- •No prior radioimmunotherapy
- 另有 4 项未显示
排除标准
- 未提供
研究者
相似试验
已完成
2 期
Epirubicin, Oxaliplatin and Fluorouracil (EOF) in Cancer of the Esophagus, Gastroesophageal Junction, or StomachGastric CancerEsophageal CancerNCT00601705Case Comprehensive Cancer Center61
已完成
1 期
Everolimus MICE-regimen in Treating Older Patients With Newly Diagnosed Acute Myeloid LeukemiaLeukemiaNCT01154439Gruppo Italiano Malattie EMatologiche dell'Adulto11
已完成
1 期
Combination Chemotherapy and Radiation Therapy With or Without Lapatinib in Treating Patients With Locally Advanced Cancer of the Larynx or HypopharynxHead and Neck CancerNCT00498953European Organisation for Research and Treatment of Cancer - EORTC7
已完成
2 期
S0350 Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Peripheral T-Cell Non-Hodgkin's LymphomaLymphomaNCT00109928SWOG Cancer Research Network34
已完成
2 期
S0220: Chemoradiotherapy Followed By Surgery and Docetaxel in Treating Patients With Pancoast TumorsLung CancerNCT00062439SWOG Cancer Research Network46