Phase II Trial Of Induction Therapy With EPOCH Chemotherapy And Maintenance Therapy With Combivir/Interferon ALPHA-2a For HTLV-1 Associated T-Cell Non-Hodgkin's Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 6
- 主要终点
- Duration of response
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. Antiviral therapy may kill viruses such as HTLV-1 that can cause cancer. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with antiviral drugs and interferon alfa may be effective in treating adult T-cell leukemia/lymphoma.
PURPOSE: Phase II trial to determine the effectiveness of combination chemotherapy followed by antiviral therapy and interferon alfa in treating patients who have adult T-cell leukemia/lymphoma caused by HTLV-1.
详细描述
OBJECTIVES:
- Determine the efficacy of etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH) followed by lamivudine, zidovudine, and interferon alfa, in terms of response rate, in patients with HTLV-1-associated adult T-cell leukemia/lymphoma.
- Determine the duration of response in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the effect of this regimen on markers of virus replication and expression and immune function in these patients.
OUTLINE: This is a multicenter study.
Patients receive EPOCH chemotherapy comprising etoposide, vincristine, and doxorubicin IV continuously on days 1-5, cyclophosphamide IV over 30 minutes on day 5, and oral prednisone on days 1-5. Patients also receive filgrastim (G-CSF) subcutaneously (SC) daily beginning on day 7 and continuing until blood counts recover. Treatment repeats every 21-28 days for at least 2 courses beyond best response or for up to 6 courses in the absence of unacceptable toxicity, disease progression, or stable disease.
Beginning 1 month after completion of EPOCH, patients receive oral lamivudine and zidovudine twice daily and interferon alfa SC daily continuously for 1 year.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed HTLV-1-associated adult T-cell leukemia/lymphoma (ATLL)
- •Previously treated ATLL allowed
- •CD3-positive
- •Documented HTLV-1 infection by serologic assay (ELISA, Western blot)
- •Measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 50-100%
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count greater than 1,000/mm^3*
- •Platelet count greater than 75,000/mm^3* NOTE: *Unless cytopenia is secondary to ATLL
- •Transaminase less than 7 times upper limit of normal
- •Bilirubin less than 2.0 mg/dL (unless secondary to hepatic infiltration with lymphoma or isolated indirect hyperbilirubinemia associated with indinavir)
- •Creatinine less than 2.0 mg/dL (unless due to lymphoma)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 6 months after study completion
- •No active opportunistic infection requiring acute therapy
- •No untreated thyroid disease
- •No autoimmune disease
- •No uncontrolled significant psychiatric disease
- •No other concurrent malignancy except carcinoma in situ of the cervix or non-metastatic nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 24 hours since prior hematologic growth factors
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •Concurrent chronic therapy with potentially myelosuppressive agents allowed
- •Other concurrent antiretroviral therapy for HIV, hepatitis B, or hepatitis C infection (or other indication) allowed at investigator's discretion for patients receiving therapy prior to study initiation
排除标准
- 未提供
结局指标
主要结局
Duration of response
时间窗: 3 years
Toxicity
时间窗: 1 year
Efficacy
时间窗: 60 days
Effects on markers of virus replication and expression and immune function
时间窗: 5 years
次要结局
未报告次要终点