NCT00335647已完成1 期
A Phase I/IIa, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerance, and Preliminary Activity of Intravenous High-Dose Fluphenazine HCI in Patients With Advanced Multiple Myeloma
Immune Control6 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluphenazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of fluphenazine and to see how well it works in treating patients with refractory advanced multiple myeloma.
详细描述
OBJECTIVES:
- Determine the safety of high-dose fluphenazine hydrochloride in patients with refractory advanced multiple myeloma.
- Determine the pharmacological properties of this drug.
- Determine the effectiveness of this drug in these patients.
OUTLINE: This is an open-label, dose-escalation study.
Patients receive high-dose fluphenazine hydrochloride IV 3 times on day 1. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of fluphenazine hydrochloride until the maximum tolerated dose is determined.
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 or cytologically confirmed multiple myeloma
- •Advanced disease
- •Must be refractory to ≥ 2 different methods of standard treatment
- •Measurable disease, defined as serum paraprotein ≥ 1g/L or urine light chain ≥ 200 mg/24 hours
- •No brain involvement or leptomeningeal disease
- •No spinal cord compression unless the following criteria are met:
- •Patient has undergone prior surgery or radiotherapy
- •Neurological findings are ≤ grade 1
- •Patient is off steroids for spinal cord edema or is on a stable regimen of ≤ 10 mg/day of prednisone or equivalent
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 (ECOG PS 3 allowed if related to skeletal lesions)
- •Life expectancy ≥ 12 weeks
- •Absolute granulocyte count ≥ 1,000/mm^3*
- •Platelet count ≥ 50,000/mm^3*
- •Hemoglobin ≥ 8.0 g/dL* (no transfusion within the past 7 days)
- •AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2 times ULN
- •Creatinine clearance ≥ 30 mL/min
- •LVEF ≥ 40%
- •QTc < 450 msec
- •No evidence of dysrhythmias on EKG
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No congestive heart failure
- •No angina pectoris
- •No cardiac arrhythmia
- •No uncontrolled hypertension, defined as systolic blood pressure (BP) > 180 mm Hg and/or diastolic BP > 105 mm Hg
- •No myocardial infarction within the past year
- •No active infection
- •No HIV, hepatitis B, or hepatitis C infection
- •No history of psychosis
- •No history of subcortical brain damage
- •No hypersensitivity to fluphenazine hydrochloride or other phenothiazines
- •No history of seizures or extrapyramidal symptoms
- •No other serious illness or medical condition
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix NOTE: *Patients with values outside of this range due to infiltration by myeloma may be allowed at the discretion of the investigator
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from prior therapy
- •At least 21 days since prior chemotherapy, immunotherapy, or radiotherapy
- •At least 21 days since prior and no concurrent systemic steroids
- •Patients who have been taking chronically administered steroids for ≥ 1 month at a dose ≤ 10 mg/day of prednisone or equivalent are eligible
- •At least 28 days since prior investigational agents
- •At least 6 weeks since prior selective serotonin reuptake inhibitors (SSRIs) (a wash-out period equivalent to 5 times the terminal elimination half-life is required for tricyclic antidepressants or norepinephrine reuptake inhibitors)
- •No concurrent SSRIs, tricyclic antidepressants, or norepinephrine reuptake inhibitors
- •No concurrent dialysis therapy
- •No concurrent hematopoietic growth factors except epoetin alfa
- •Treatment with hematopoietic growth factors may be started during study if patient develops or has progressive cytopenia
- 另有 2 项未显示
排除标准
- 未提供
结局指标
主要结局
Efficacy
Safety
次要结局
未报告次要终点
研究者
研究点 (6)
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