Prospective Non Randomized Study With Chemotherapy in Patients With Hodgkin's Disease and HIV Infection: "Stanford V Regimen" For "Low Risk" Patients, "EBVP Regimen" For "High Risk" Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of two combination chemotherapy regimens in treating patients with Hodgkin's disease and HIV infection.
详细描述
OBJECTIVES:
- Investigate the effects on survival, life expectancy and quality, toxicity, and immunological status in low risk patients with Hodgkin's Disease and HIV infection treated with the Stanford V regimen and in high risk patients treated with epirubicin, bleomycin, vinblastine, and prednisone.
OUTLINE: Patients are stratified into 2 groups designated as low and high risk on the basis of ECOG performance status (0-2 vs 3-4), presence or absence of AIDS before the diagnosis of Hodgkin's Disease, and immune status (CD4+ cell count greater vs no greater than 100/mm^3).
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Low risk patients (those with no risk factors) receive the EBVP regimen, as follows:
-
Epirubicin intravenously on day 1
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Bleomycin intramuscularly or intravenously on day 1
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Vinblastine intravenously on day 1
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Prednisone orally on days 1-5
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Patients also receive daily injections of filgrastim (granulocyte colony-stimulating factor; G-CSF) on days 6-15. This schedule is repeated every 3 weeks for 6 courses.
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High risk patients (those with one or more risk factors) receive the Stanford V regimen, as follows:
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 proven Hodgkin's disease:
- •Clinical or pathologic stage II - IV
- •Stage I with bulky disease (tumor size greater than 10 cm) and B symptoms
- •Confirmed HIV infection
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular:
- •No severe cardiac disease
- •No severe pulmonary disease
- •No severe neurologic or metabolic disease
- •No concurrent or prior second malignancy except:
- •Nonmelanomatous skin cancer
- •In situ cancer of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •No prior therapy for Hodgkin's disease
- •Concurrent triple-drug antiretroviral therapy (including one protease inhibitor) required
排除标准
- 未提供
