NCT00589381已完成1 期
Phase I Trial of Fenretinide (4-HPR, NSC 374551) Lym-X-Sorb™ (LXS) Oral Powder (4-HPR/LXS Oral Powder) (4-HPR) in Adults With Solid Tumors and Lymphomas
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 8
- 主要终点
- Maximum tolerated dose of 4-HPR/LXS oral powder
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fenretinide Lym-X-Sorb™ , 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 trial is studying the side effects and best dose of fenretinide Lym-X-Sorb™ in treating patients with recurrent or resistant solid tumors or lymphoma.
详细描述
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of fenretinide Lym-X-Sorb™ oral powder (4-HPR/LXS oral powder) in patients with recurrent and/or resistant solid tumors or lymphomas.
- To define the toxicities of 4-HPR/LXS oral powder in these patients.
- To determine the plasma pharmacokinetics of 4-HPR/LXS oral powder in these patients.
Secondary
- To determine the level of fenretinide delivered as 4-HPR/LXS oral powder in normal peripheral blood mononuclear cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 (by the NIH pathology department) diagnosis of 1 of the following:
- •Solid tumor malignancy that is metastatic or unresectable
- •Lymphoma for which standard treatment or curative measures do not exist, or are associated with minimal patient survival benefit
- •Recurrent and/or resistant disease
- •Measurable or evaluable disease
- •No known brain metastases
- •Patients whose brain metastatic disease status has remained stable for ≥ 3 months after treatment may be eligible at the discretion of the principal investigator (without steroids or anti-seizure medications)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- •Life expectancy ≥ 3 months
- •Absolute neutrophil count ≥ 1,500/µL
- •Platelets ≥ 100,000/µL (CTCAE v.3 grade 1 thrombocytopenia allowed if explained by involvement of the bone marrow by lymphoma)
- •Total bilirubin ≤ 1.5 times normal institutional limits (2.5 mg/dL for patients with Gilbert's syndrome)
- •AST (SGOT)/ALT (SGPT) ≤ 2.5 times upper limit of normal (ULN)
- •Creatinine < 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use two methods of birth control, including at least one highly effective method (e.g., intrauterine device [IUD], hormonal birth control pills/injections/implants, tubal ligation or partner's vasectomy), and one additional effective method (e.g., latex condoms, diaphragm, or cervical cap), prior to, during, and for 2 months after completion of study treatment
- •Men must use a latex condom every time they have sexual intercourse during therapy and for 2 months after discontinuing fenretinide, even if they have had a successful vasectomy
- •No clinically significant illnesses which could compromise participation in the study, including, but not limited to, any of the following:
- •Active or uncontrolled infection
- •Immune deficiencies or confirmed diagnosis of HIV infection
- •Uncontrolled diabetes
- •Uncontrolled hypertension
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Myocardial infarction within the past 6 months
- •Uncontrolled cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •No known wheat gluten allergy or allergy or sensitivity to the study drug
- •No history of pancreatitis as evidenced by elevated amylase or lipase ≥ grade 2 and accompanied by symptoms of pancreatitis (e.g., abdominal pain)
- •PRIOR CONCURRENT THERAPY:
- •Recovered from adverse events and/or toxicity due to prior chemotherapy or biologic therapy
- •No chemotherapy or biologic therapy within 4 weeks prior to entering the study (6 weeks for nitrosoureas, mitomycin C, or UCN-01)
- •At least 1 month since any prior radiotherapy or major surgery
- •At least 2 weeks since any prior administration of study drug in an exploratory IND/phase 0 study
- •Patients receiving bisphosphonates for any cancer or undergoing androgen deprivation therapy for prostate cancer are eligible for this therapy
- •No concurrent sulfonamides
- •No other concurrent investigational agents
- •No other concurrent cancer chemotherapy, or immunomodulating agents (including systemic corticosteroids)
- •Patients must not take any drugs suspected of causing pseudo tumor cerebri, including any of the following:
- •Tetracycline
- •Nalidixic acid
- •Nitrofurantoin
- •Phenytoin
- •Sulfonamides
- •Amiodarone
- •Vitamin A (except as part of routine total parenteral nutrition vitamin supplements or in a single daily standard dose oral multivitamin supplement)
- •No concurrent herbal supplements or other alternative therapy medications
排除标准
- 未提供
结局指标
主要结局
Maximum tolerated dose of 4-HPR/LXS oral powder
Safety
Toxicity
次要结局
- Level of fenretinide in normal peripheral blood mononuclear cells
研究者
研究点 (8)
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