Combination Chemotherapy Followed By Antiviral Therapy and Interferon Alfa in Treating Patients With HTLV-1-Related Adult T-Cell Leukemia/Lymphoma
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
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.
研究概览
地位
条件
详细说明
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.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 10-32 patients will be accrued for this study within 1-2 years.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
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California
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Los Angeles、California、美国、90089-9181
- USC/Norris Comprehensive Cancer Center and Hospital
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Florida
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Miami、Florida、美国、33136
- University of Miami Sylvester Comprehensive Cancer Center
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Missouri
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Saint Louis、Missouri、美国、63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age:
- 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
Hepatic:
- 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)
Renal:
- Creatinine less than 2.0 mg/dL (unless due to lymphoma)
Other:
- 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
Surgery:
- Not specified
Other:
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
反应持续时间
大体时间:3年
|
3年
|
|
毒性
大体时间:1年
|
1年
|
|
Efficacy
大体时间:60 days
|
60 days
|
|
Effects on markers of virus replication and expression and immune function
大体时间:5 years
|
5 years
|
合作者和调查者
调查人员
- 学习椅:Lee Ratner, MD, PhD、Washington University Siteman Cancer Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
- 免疫系统疾病
- 组织学类型的肿瘤
- 肿瘤
- 淋巴增生性疾病
- 淋巴系统疾病
- 免疫增生性疾病
- 白血病、淋巴细胞
- 白血病
- 淋巴瘤
- 白血病,T细胞
- 白血病-淋巴瘤,成人 T 细胞
- 药物的生理作用
- 药理作用的分子机制
- 抗感染药
- 抗病毒药物
- 逆转录酶抑制剂
- 核酸合成抑制剂
- 酶抑制剂
- 抗艾滋病药物
- 抗逆转录病毒药物
- 抗炎药
- 抗风湿药
- 抗代谢物
- 抗肿瘤药
- 免疫抑制剂
- 免疫因素
- 微管蛋白调节剂
- 抗有丝分裂剂
- 有丝分裂调节剂
- 糖皮质激素
- 荷尔蒙
- 激素、激素替代品和激素拮抗剂
- 抗肿瘤药,激素
- 抗肿瘤药,烷基化
- 烷化剂
- 清髓性激动剂
- 抗肿瘤药,植物性
- 拓扑异构酶 II 抑制剂
- 拓扑异构酶抑制剂
- 抗生素、抗肿瘤药
- 干扰素
- 干扰素-α
- 环磷酰胺
- 依托泊甙
- 强的松
- 拉米夫定
- 齐多夫定
- 阿霉素
- 脂质体阿霉素
- 长春新碱
其他研究编号
- AMC-033
- U01CA070019 (美国 NIH 拨款/合同)
- CDR0000069469 (其他标识符:NCI)
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