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临床试验/NCT00003262
NCT00003262Unknown2 期

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

Centro di Riferimento Oncologico - Aviano1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 1997年5月1日最近更新:
适应症
相关药物

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).

  • Low risk patients (those with no risk factors) receive the EBVP regimen, as follows:

  • Epirubicin intravenously on day 1

  • Bleomycin intramuscularly or intravenously on day 1

  • Vinblastine intravenously on day 1

  • Prednisone orally on days 1-5

  • 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.

  • 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

研究者

申办方类型
Other

研究点 (1)

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