NCT00061880已完成1 期
Phase 1-2 Multi-Center Study of Intravenous BCX-1777 in Patients With Refractory Cutaneous T-Cell Lymphoma (CTCL)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 6
研究概览
简要总结
RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractory cutaneous T-cell lymphoma.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma.
- Determine the efficacy of this drug in these patients.
- Determine the toxicity profile of this drug in these patients.
- Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug.
- Determine the provisional optimal biological dose of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.
- Phase I: Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 (a total of 9 doses). Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 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 cutaneous T-cell lymphoma (CTCL)
- •Any stage except IA patch only
- •Previously treated according to 1 of the following:
- •Stage IA plaque, IB, or IIA:
- •At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light [PUVA] and systemic corticosteroids)
- •Stage IIB, III, or IV:
- •At least 1 prior systemic regimen (systemic corticosteroids and PUVA do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered one regimen
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Granulocyte count at least 2,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Hemoglobin at least 10.0 g/dL
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
- •ALT no greater than 2 times ULN
- •Alkaline phosphatase no greater than 2 times ULN
- •No hepatitis B or C
- •Creatinine clearance at least 45 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •Human T-cell leukemia virus type 1 (HTLV-1) negative
- •No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No other illness that would limit study participation
- •No active serious infection not controlled by antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent anticancer antibody therapy
- •No concurrent anticancer immunotherapy
- •No concurrent anticancer gene therapy
- •No concurrent anticancer vaccine therapy
- •No concurrent anticancer angiogenesis inhibitors
- •No concurrent sargramostim (GM-CSF)
- •No concurrent filgrastim (G-CSF) during course 1 of therapy
- •Chemotherapy
- •More than 21 days since prior chemotherapy unless fully recovered
- •No concurrent anticancer chemotherapy
- •Endocrine therapy
- •See Disease Characteristics
- •More than 2 weeks since prior topical corticosteroids
- •No concurrent anticancer hormonal therapy
- •Radiotherapy
- •More than 2 weeks since prior radiotherapy
- •No concurrent radiotherapy
- 另有 8 项未显示
排除标准
- 未提供
研究者
研究点 (6)
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