NCT00006383已完成2 期
Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Diffuse Large B-Cell Non-Hodgkin's Lymphoma That is Refractory or Relapsed After Second-Line Combination Chemotherapy Revised Title Per 03/01 SR Pivotal Phase II Multicenter Study of Vincristine Sulfate Liposomes Injection in Aggressive Non-Hodgkin's Lymphoma That is Refractory to or Relapsed After Second-Line Combination Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 9
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of liposomal vincristine in treating patients who have refractory or relapsed non-Hodgkin's lymphoma.
详细描述
OBJECTIVES:
- Determine the complete and partial tumor responses in patients with aggressive non-Hodgkin's lymphoma that is refractory to or relapsed after second-line combination chemotherapy treated with vincristine sulfate liposomes injection.
- Determine the toxicity of this treatment regimen in these patients.
- Determine the duration of response, time to progression, and survival in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive vincristine sulfate liposomes IV over 1 hour. Treatment repeats every 2 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
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 confirmed aggressive non-Hodgkin's lymphoma including:
- •Peripheral T-cell lymphoma not otherwise specified
- •Anaplastic large null-/T-cell lymphoma
- •Diffuse large B-cell lymphoma including:
- •Primary mediastinal large B-cell lymphoma with sclerosis
- •Intravascular large B-cell lymphoma
- •Immunoblastic B-cell lymphoma
- •T-cell-rich B-cell lymphoma
- •Anaplastic large B-cell lymphoma
- •At least one bidimensionally measurable lesion with clearly defined margins at least 2 cm in the largest dimension by physical examination or CT scan
- •No prior or active CNS lymphoma or AIDS-related lymphoma
- •Must have received 2 or more prior chemotherapy courses from time of diagnosis of aggressive lymphoma or from time of biopsy-proven transformation from indolent to aggressive
- •Prior first and second-line therapy must have been combination chemotherapy
- •Prior first-line chemotherapy regimen must have contained anthracycline
- •Must have had at least a minor response to first-line therapy
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Granulocyte count at least 500/mm^3 (unless due to lymphoma bone marrow involvement)
- •Platelet count at least 50,000/mm^3 (unless due to lymphoma bone marrow involvement)
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •ALT no greater than 4 times ULN
- •Alkaline phosphatase no greater than 4 times ULN
- •Not specified
- •Neurologic:
- •No prior neurological disorders unrelated to chemotherapy (including familial neurological diseases or acquired demyelinating disorders)
- •No neuromuscular impairment (neuromotor, neurosensory, or neurocerebellar)
- •No prior grade 3 or 4 sensory or motor neuropathy related to chemotherapy
- •No uncontrolled severe medical illness or infection
- •HIV negative
- •No other malignancies within the past 5 years except curatively resected basal cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Radiotherapy
- •No prior allogeneic bone marrow or peripheral blood stem cell transplantation
- •At least 4 weeks since prior immunotherapy
- •No concurrent biological agents
- •Chemotherapy:
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior corticosteroids at a dose greater than 10 mg/day of prednisone or equivalent
- •Radiotherapy:
- 另有 11 项未显示
排除标准
- 未提供
研究者
研究点 (9)
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