NCT00019656已完成1 期
A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer.
详细描述
OBJECTIVES:
- Determine the dose-limiting toxicity and maximum tolerated dose of perifosine administered as a varying series of loading and maintenance doses in patients with refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma.
- Determine the profile of adverse reactions (including changes in laboratory parameters) in patients treated with this regimen.
- Determine any disease responses that may occur in patients treated with this regimen.
- Determine the steady-state pharmacology and pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose 2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose level.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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 solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy
- •No history of CNS neoplasms
- •For prostate cancer:
- •Tumor progression during blockade of testicular and adrenal androgens
- •At least 4 weeks since prior flutamide or other antiandrogens without disease improvement
- •Leuprolide or other gonadotropin-releasing hormones should be maintained in patients without an orchiectomy
- •Testosterone in the castrate range
- •For breast cancer:
- •At least 4 weeks since any prior hormonal therapy with evidence of disease progression
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Platelet count greater than 50,000/mm^3
- •Absolute granulocyte count greater than 500/mm^3
- •Hemoglobin at least 9.0 g/dL
- •Bilirubin no greater than 1.5 mg/dL
- •SGOT and SGPT no greater than 2.5 times normal
- •Creatinine no greater than 1.5 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No history of unstable or newly diagnosed angina pectoris
- •No myocardial infarction within the past 6 months
- •No New York Heart Association class II-IV heart disease
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •No recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer or enteritis) that might affect tolerability or drug absorption
- •No allergic reaction to any medication with a structure similar to perifosine
- •No pre-existing retinal disease or pathologic baseline electrooculogram
- •No cataracts that would interfere with normal vision or require medical intervention
- •No other serious concurrent illness that would preclude assessment of drug effect
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •At least 2 months since prior UCN-01
- •More than 3 months since prior suramin
- •Endocrine therapy:
- •See Disease Characteristics
- •No concurrent corticosteroids except for physiological replacement or as antiemetics
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy (6 weeks for bone-seeking radioisotopes) and recovered
- •See Disease Characteristics
- •No other concurrent antineoplastic therapies
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate CancerProstate CancerNCT00060437National Cancer Institute (NCI)
已完成
2 期
Perifosine in Treating Patients With Metastatic or Recurrent Malignant MelanomaMelanoma (Skin)NCT00053781NCIC Clinical Trials Group18
已完成
2 期
Perifosine in Treating Patients With Metastatic or Locally Advanced Soft Tissue SarcomaEndometrial CancerSarcomaNCT00053794NCIC Clinical Trials Group17
已完成
2 期
Perifosine in Treating Patients With Advanced Pancreatic CancerPancreatic CancerNCT00053924University Health Network, Toronto
已完成
2 期
Perifosine in Treating Patients With Recurrent, Refractory, Locally Advanced, or Metastatic Breast CancerBreast CancerNCT00054145University Health Network, Toronto