A Pilot Study of Flavopiridol in Patients With Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adverse events of dose escalated alvocidib administered in patients with advanced solid tumors
研究概览
简要总结
This phase I trial is studying the side effects and best dose of alvocidib in treating patients with locally advanced or metastatic solid tumors. Drugs used in chemotherapy, such as alvocidib, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Alvocidib may also stimulate the immune system in different ways and stop tumor cells from growing. It may also stop the growth of solid tumors by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Determine the toxicity profile and dose-limiting toxicity of flavopiridol (alvocidib) in patients with locally advanced or metastatic solid tumors.
II. Determine the maximum tolerated dose of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed solid tumor
- •Locally advanced or metastatic disease for which curative treatment does not exist or is no longer effective
- •Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •No previously irradiated* measurable lesion unless lesion demonstrates progressive disease OR there are other measurable lesions outside the irradiated* field
- •The following are not considered measurable disease:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural or pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •No uncontrolled brain metastases
- •Performance status - ECOG 0-1
- •At least 6 months
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No uncontrolled cardiac arrhythmia
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to flavopiridol
- •No ongoing or active infection
- •No uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •More than 12 weeks since prior hepatic arterial chemoembolization
- •More than 4 weeks since prior systemic chemotherapy
- •No prior flavopiridol
- •See Disease Characteristics
- •More than 12 weeks since prior radioactive metaiodobenzylguanidine (MIBG)
- •More than 4 weeks since prior external beam radiotherapy
- •Recovered from all prior tumor-specific therapy
- •More than 4 weeks since prior investigational tumor-specific therapy
- •Concurrent octreotide for control of carcinoid syndrome allowed
- •No concurrent combination anti-retroviral therapy for HIV-positive patients
- •No other concurrent tumor-specific therapy
- •No other concurrent investigational therapy
- •No other concurrent anticancer therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy, biological therapy)
Patients receive alvocidib IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: alvocidib (Drug)
Treatment (chemotherapy, biological therapy)
Patients receive alvocidib IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Treatment (chemotherapy, biological therapy)
Patients receive alvocidib IV over 4½ hours once weekly in weeks 1-4. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Adverse events of dose escalated alvocidib administered in patients with advanced solid tumors
时间窗: At weeks 1-4, 7-10, 11 or 12, and within 4 weeks after the completion of study treatment
Graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
次要结局
- Pharmacokinetics of alvocidib administered in this schedule(After the first dose of treatment drug)
- Pharmacogenomics studies on procured PBMCs if clinical responses are observed(Baseline, and within 4 weeks after the completion of study treatment)
- Measurement of serum tumor markers depending on the tumor type(Baseline, week 11 or 12, and within 4 weeks after the completion of study treatment)
- Immunomodulatory effects of alvocidib(Baseline, days 1 and 15 of courses 1 and 2, and within 4 weeks after the completion of study treatment)