Study of Liposome Encapsulated Mitoxantrone (LEM) in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 8
研究概览
简要总结
Liposome entrapped mitoxantrone (LEM) is a mixture of commercially available mitoxantrone HCL (Novantrone) and a combination of lyophilized lipids. Mitoxantrone, the active agent in the investigational formulation, is a currently marketed chemotherapeutic agent. The rationale for development of liposomal formulations is primarily that of improving the safety profile of the drug, which may permit dose intensification and/or an increase in the cumulative dose that may be administered, resulting in enhanced efficacy.
LEM will be given to patients with advanced solid tumors to determine the dose of drug these patients can tolerate. Patients will receive intravenous LEM every 21 days until the disease progresses or toxicity occurs requiring treatment discontinuation. Anti-tumor effects of LEM will be assessed and patients will be evaluated for safety and tolerability.
详细描述
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of LEM.
II. Measure the blood pharmacokinetics of LEM following IV administration.
III. Observe any anti-tumor effects of LEM.
PROTOCOL OUTLINE: This is an open-label study for patients with advanced and/or metastatic, histologically-documented solid tumors considered to be unresponsive to available conventional treatment.
LEM will be administered IV over 45 minutes. At least three patients will be studied at each dose level and at least three patients will complete one 21-day course before any patient is enrolled at the next dose level. Study drug administration will continue on an every 3-week schedule in the absence of progressive disease or unacceptable toxicity. A subsequent course of treatment may be administered at least 21 days after a prior LEM dose has been administered when study criteria are met.
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-
- •Advanced (local and/or metastatic) histologically documented solid tumors
- •Disease is not considered responsive to available conventional modalities or treatments
- •Prior/Concurrent Therapy-
- •Must be fully recovered from acute toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities (returned to baseline before most recent treatment)
- •No radiotherapy, treatment with cytotoxic or biologic agents within 3 weeks prior to study entry (6 weeks for mitomycin or nitrosoureas)
- •At least 2 weeks after any prior surgery or hormonal therapy
- •Chronic toxicities of grade 1 from prior treatment are permitted
- •Patient Characteristics-
- •ECOG Performance status of 0-2
- •Must be at least 18 years of age
- •Must have the following clinical laboratory values: ANC at least 1,500/mm3; Platelets at least 100,000/mm3; Hemoglobin at least 10 g/dL; albumin at least 3.0 mg/dL; Serum creatinine at least 2.0 mg/dL; Total bilirubin not more than upper limit of normal; ALT, AST, and alkaline phosphatase not more than 1.5 x upper limit of normal; LVEF by MUGA scan greater than or equal to the lower limit of normal
- •Must sign informed consent
- •No pregnant and/or nursing patients. Women of child-bearing potential must have negative serum or urine pregnancy test within 1 week prior to study entry. Sexually-active patients (both men and women) must use acceptable contraceptive methods.
- •No active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease)
- •No active infection of any kind
- •No known HIV infection or viral hepatitis
- •No active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmias requiring medication, or congestive heart failure
- •No known CNS metastases
- •No patients receiving any other standard or investigational treatment for their cancer, or any other investigational agent for any indication
- •No patients requiring immediate palliative treatment of any kind including surgery
- •No patients who have received a high-dose chemotherapy regimen with stem cell support in the previous 6 months
- •No patients who have received a cumulative anthracycline dose greater than 250 mg/m2 (doxorubicin equivalent)
- •No patients unwilling or unable to follow protocol requirements
- •No patients with known hypersensitivity to mitoxantrone or liposomes.
排除标准
- 未提供