A Randomized Phase II Study of Oral Lenalidomide (Revlimid [TM]), an Antiangiogenic and Immunomodulatory Agent, in Subjects With Stage IV Ocular Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Clinical Responses in Patients With Metastatic Ocular Melanoma
研究概览
简要总结
This study will test whether an experimental drug called Revlimid (lenalidomide) can reduce tumor size and prolong survival in patients with metastatic melanoma (melanoma that has spread beyond the original tumor site). It will also examine the toxicity and blood effects of Revlimid.
Patients 18 years of age and older with stage IV ocular melanoma may be eligible for this study. Candidates are screened with a medical history and physical and examination, blood and urine tests, electrocardiogram, chest x-ray, computed tomography (CT) scan and other imaging scans if needed, such as a bone scan, magnetic resonance imaging (MRI), ultrasound, or positron emission tomography (PET).
Participants are admitted to the National Institutes of Health (NIH) Clinical Center for 24 hours for their first oral dose of Revlimid. During the hospital stay, blood is drawn before the dose is given and again at 0.25, 0.5, 1, 2, 4, 6, 9, 12 and 24 hours after dosing to see how the body handles the drug. If the drug is well tolerated, patients are sent home with a 21-day supply of drug to take once a day for 21 days, then go off drug 7 days. This regimen constitutes one 28-day treatment cycle. Treatment cycles may continue for up to 2 years.
Patients keep a daily diary of side effects and have blood drawn once a week. The drug dose may be adjusted according to the laboratory test results. If unacceptable toxicity occurs, treatment may be stopped.
Patients who agree to be biopsied undergo this procedure before treatment begins and at the end of treatment cycles 3 and 6. A small area of skin is numbed with medicine and a small piece of tumor is removed with a needle or by a small cut in the tumor. The tissue is examined under a microscope.
Patients return to NIH after the first month of treatment and then every 3 months to evaluate their tumors and treatment of side effects. The visits include a physical examination, x-rays and scans to evaluate tumors. Visits are scheduled every 3 months while on treatment; then every 3 months for 2 years afterwards; then every 4 months for 1 year; and as needed after that. Patients will have a brain magnetic resonance imaging scan once a year to watch for new tumor areas.
详细描述
Background:
- Patients with stage IV ocular melanoma have very few available treatment options and an overall poor prognosis.
- Pre-clinical and early clinical evidence suggest that lenalidomide has activity against solid tumors.
- This trial is designed to evaluate the safety and efficacy of two different doses of a novel antiangiogenic and immunomodulatory agent, lenalidomide (Revlimid ).
Objectives:
Primary Objectives:
- Determine the response rate to lenalidomide at two dose levels for patients with Stage IV ocular melanoma.
- To determine the toxicity of lenalidomide at two dose levels in this setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1 - 25 mg lenalidomide (Revlimid)
oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
干预措施: Revlimid (Drug)
Cohort 2 - 5 mg lenalidomide (Revlimid)
oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
干预措施: Revlimid (Drug)
结局指标
主要结局
Clinical Responses in Patients With Metastatic Ocular Melanoma
时间窗: 12 months
Clinical response is assessed by the Response Evaluation Criteria for Adverse Events in Solid Tumors (RECIST). Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Progressive disease (PD) is at least a 20% increase in the sum of the LD of target lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Number of Participants With Adverse Events
时间窗: 24 months
Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
次要结局
- Progression Free Survival(up to 2 years)
- Determine Pharmacokinetics of Lenalidomide at Two Dose Levels: 5 mg and 25 mg(Prior to treatment on cycle 1, day 1 and then on cycle 1, day 1 at 0.25, 0.5, 1, 2, 4, 6, 9 and 12 hours. Cycle 1, day 2 at 24 hours.)
- Overall Survival(up to 2 years)
- Determine Dose Level With Superior Efficacy and Acceptable Toxicity(up to 2 years)
- Evaluate Effects of Lenalidomide on Pathways(Baseline and at the end of treatment cycles 3 and 6. Every 21 day supply of lenalidomide with a 7 day rest (total of 28 days) will be considered a cycle of therapy.)
研究者
Caryn Steakley, R.N.
Principal Investigator
National Institutes of Health Clinical Center (CC)