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临床试验/NCT00041327
NCT00041327已完成2 期

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

AIDS Malignancy Consortium6 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2002年10月1日最近更新:
适应症
相关药物

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

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

研究者

发起方
AIDS Malignancy Consortium
申办方类型
Network
责任方
Sponsor

研究点 (6)

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