NCT00004106终止2 期
Phase II Trial of Temozolomide for the Treatment of Mycosis Fungoides and the Sezary Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 6
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying temozolomide to see how well it works in treating patients with mycosis fungoides or Sezary syndrome that has not responded to previous treatment.
详细描述
OBJECTIVES:
- Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome.
- Determine the toxic effects of this drug in these patients.
- Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year.
Patients are followed every 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed mycosis fungoides or Sezary syndrome
- •Stage IB-IVB disease
- •Must have failed at least one prior systemic therapy
- •Generalized erythroderma allowed
- •Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only
- •Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •WBC at least 3,000/mm^3
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 2.2 mg/dL
- •SGOT or SGPT no greater than 2 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No clinically significant peripheral venous insufficiency
- •HIV negative
- •No poorly controlled diabetes mellitus
- •No acute infection requiring IV antibiotics
- •No other medical condition that would prevent ingestion or absorption of oral medication
- •No other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy and recovered
- •No concurrent growth factors or epoetin alfa
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy:
- •At least 4 weeks since prior topical steroids
- •Radiotherapy:
- •See Disease Characteristics
- •At least 2 weeks since prior radiotherapy for local control or palliation and recovered
- •Recovered from prior major surgery
- •No other concurrent investigational drugs
排除标准
- 未提供
结局指标
主要结局
Response rate
时间窗: After every 2 cycles of therapy
Disease response will be assessed using bi-dimensional measurements of lesions with clearly defined margins by medical photograph (skin lesion) or by radiological imaging (internal lesions).
次要结局
未报告次要终点
研究者
研究点 (6)
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