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临床试验/NCT00225173
NCT00225173终止2 期

A Phase II Trial of Stanford VI ± Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's Disease With 3+ Risk Factors: the G6 Study

Stanford University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2001年10月最近更新:
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适应症
干预措施

试验速览

阶段
2 期
状态
终止
入组人数
45
试验地点
1
主要终点
Freedom from progression
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Patients with 3 or more adverse prognostic factors have a higher relapse rate. Significant anti-tumor activity in Hodgkin's lymphoma has been reported with two new drugs:gemcitabine and vinorelbine. The introduction of these new agents with their different mechanisms of action into the Stanford V regimen may increase effectiveness while maintaining a favorable toxicity profile with respect to fertility and a low risk of secondary leukemia. On this basis, we propose a new regimen, Stanford VI, for patients with bulky and advanced HD with 3 or more risk factors.

详细描述

Patients will receive chemotherapy weekly for 19 weeks, alone or followed by irradiation as indicated per protocol guidelines.

  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

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 70 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Untreated, locally extensive or advanced stage classical Hodgkin's disease
  • •3 or more adverse risk factors
  • •Age > 18 years and < 70 years.
  • •No prior invasive malignancies for > 5 years except curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • •ECOG performance status 0 to 2
  • •WBC > 4000/µL
  • •Platelets > 100,000/µL
  • •Creatinine < 2.0mg/dL
  • •Bilirubin < 5.0mg/dL

排除标准

  • •HIV-positive
  • •Pregnant or currently breast feeding women
  • •Lymphocyte predominant Hodgkin's disease

研究组 & 干预措施

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Doxorubicin (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Vinblastine (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Cyclophosphamide (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Etoposide (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Vincristine (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Bleomycin (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Gemcitabine (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Vinorelbine (Drug)

Treatment

Experimental
  • Doxorubicin 25 mg/m2 IV w 1,3,5,7,9,11
  • Vinblastine 6 mg/m2 IV w 1,3,5,7,9,11
  • Cyclophosphamide 750 mg/m2 IV w 1, 5, 9
  • Etoposide2 60 mg/mg2 x 2 IV w 3, 7,11
  • Vincristine1 1.4 mg/m2 IV w 2,4,6,8,10,12 (cap @ 2mg)
  • Bleomycin 5 u/m2 IV w 2,4,6,8,10,12
  • Gemcitabine 1250 mg/m2 IV w 13,15,17,19
  • Vinorelbine 25 mg/m2 IV w 13,15,17,19
  • Prednisone 40 mg/m2 PO qod w 1-10, taper

干预措施: Prednisone (Drug)

结局指标

主要结局

Freedom from progression

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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