A Phase II, Multicentre, Open, Randomised, Dose Ranging Study to Investigate the Efficacy of Combination Therapy Containing Dacarbazine (DTIC) Plus Low Dose Interferon Alpha (aIFN) Plus Thymosin a1 Versus Both DTIC Plus Thymosin a1 and DTIC Plus aIFN in Patients With Advanced -Stage Metastatic Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 64
- 主要终点
- Overall Tumor Response
研究概览
简要总结
The purpose of the study is to test safety and efficacy of different doses of thymosin alpha 1 (1.6 mg, 3.2 mg, and 6.4 mg) in combination with dacarbazine and with or without Interferon alpha in treating patients affected by stage IV melanoma.
Primary end-point is Tumor Response evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST). Secondary end-points are Overall Survival and Progression Free Survival.
Ninety-five patients are allocated to each arm to test the hypothesis that P0 <= 0.05 vs the alternative hypothesis that P1 >= 0.15 (alpha = 5%, within-group statistical analysis beta = 95%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have read and signed the informed consent form
- •18 years <=Age<= 75 years
- •Adequate contraception practice (fertile female patient)
- •Confirmed diagnosis of metastatic melanoma (stage IV) with unresectable metastases and >= 1 measurable lesion
- •Adequate renal function as demonstrated by serum creatinine level < 1.5 mg/deciliter (dl)
- •Absolute Neutrophil Count (ANC) >= 1.5 x 10000000000/L ; platelets >= 100 x 10000000000/Liter (L)
- •Good performance status: PS <= 1 (ZUBROD-ECOG-WHO scale)
- •At least 12 week life expectancy
排除标准
- •Clinical diagnosis of autoimmune disease
- •Transplant recipient
- •Pregnancy documented by a urine pregnancy test or lactation
- •Previous treatment with thymosin alpha 1
- •Previous treatment with chemotherapy
- •Presence of Central Nervous System (CNS) metastases
- •Concomitant or prior history of malignancy other than melanoma
- •Participation in another investigational trial within 30 days of study entry
- •Active infectious process that is not of self-limiting nature
研究组 & 干预措施
Dacarbazine + Interferon alpha + thymosin-alpha-1 1.6 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
干预措施: Dacarbazine + Interferon alpha + Thymosin-alpha-1 1.6 mg (Biological)
Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
干预措施: Dacarbazine + Interferon alpha + Thymosin-alpha-1 3.2 mg (Biological)
Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
干预措施: Dacarbazine + Interferon alpha + Thymosin-alpha-1 6.4 mg (Biological)
Dacarbazine + Thymosin-alpha-1 3.2 mg
Dacarbazine 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
干预措施: Dacarbazine + Thymosin-alpha-1 3.2 mg (Biological)
Dacarbazine + Interferon alpha
Dacarbazine 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
干预措施: Dacarbazine + Interferon alpha (Drug)
结局指标
主要结局
Overall Tumor Response
时间窗: 1 year
Tumor response is measured according to Response Evaluation Criteria In Solid Tumors (RECIST) computing number of Complete Response plus Partial Response
次要结局
- Overall Survival(2 years)
- Progression Free Survival(2 years)