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Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma

2015年11月24日 更新者:Memorial Sloan Kettering Cancer Center

A Phase II Study of SU11248 (Sunitinib) in Patients With Renal Cell Carcinoma and Melanoma Metastatic to the Brain

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with brain metastases caused by kidney cancer or melanoma.

研究概览

详细说明

OBJECTIVES:

Primary

  • Determine the efficacy of sunitinib malate, in terms of objective radiographic response of brain lesions, in patients with brain metastases secondary to renal cell carcinoma or melanoma.

Secondary

  • Determine overall and progression-free survival.

OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

研究类型

介入性

注册 (实际的)

8

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New York
      • New York、New York、美国、10021
        • Memorial Sloan-Kettering Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 120年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed melanoma or renal cell carcinoma

    • Metastatic brain disease
  • Must have assessable target intracranial lesion(s), defined as measurable disease ≥ 10 mm in longest diameter that is not appropriate for stereotactic radiosurgery or surgical resection

    • Lesions previously treated with radiosurgery AND not eligible for resection can only be used as target lesions if there has been true tumor progression on baseline scan (i.e., ≥ 20% increase in longest diameter of lesion) rather than radionecrosis

      • True progression must be confirmed by PET scan or other corroborating imaging used to distinguish radionecrosis
  • No leptomeningeal metastases or primary dural metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 60-100%
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Total leukocyte count ≥ 3,000/mm³
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 2.0 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Hemoglobin ≥ 9.0 g/dL
  • Calcium ≤ 12.0 mg/dL
  • AST and ALT ≤ 1.5 times ULN
  • PT ≤ 1.5 times ULN
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • No uncontrolled medical illness including, but not limited to, any of the following:

    • Hypertension (i.e., blood pressure > 150/100 mm Hg)
    • Thyroid disease
    • Severe valvular disease
    • Severe pulmonary disease
    • HIV/AIDS
    • Severe psychiatric illness
  • No cardiac dysrhythmia ≥ grade 2
  • No prolonged QTc interval on baseline EKG
  • No systemic hemorrhage ≥ grade 2 within the past 4 weeks

    • No CNS hemorrhage ≥ grade 2

      • Grade 1 (asymptomatic) CNS hemorrhage allowed at investigator's discretion
  • None of the following within the past 6 months:

    • Myocardial infarction
    • Unstable angina
    • Symptomatic congestive heart failure
    • Stroke/transient ischemic attack
    • Pulmonary embolism
  • Ejection fraction ≥ 50% by baseline echocardiogram OR < 20% decrease in ejection fraction from a prior study

PRIOR CONCURRENT THERAPY:

  • No prior multi-targeted tyrosine kinase inhibitor therapy (e.g., sunitinib malate or sorafenib)
  • No coronary/peripheral arterial bypass surgery within the past 6 months
  • More than 4 weeks since prior surgery and recovered
  • More than 4 weeks since prior and no other concurrent experimental therapy or cytotoxic chemotherapy
  • More than 4 weeks since prior immunotherapy
  • More than 2 weeks since prior stereotactic radiosurgery and recovered
  • More than 7 days since prior and no concurrent drugs that interact with CYP3A4 family, including enzyme-inducing antiepileptic drugs, warfarin, or Hypericum perforatum extract (St. John's wort)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Sunitinib
Patients will be treated with 50 mg daily for four out of every six weeks.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Central Nervous System (CNS) Response Rate by RECIST Criteria
大体时间:up to a year
Response and progression will be evaluated in this study using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in RECIST. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques (CT, MRI, X-ray) or as >10 mm with spiral CT scan. This study will use a minimum diameter of 10 mm for measurable lesions in the brain, regardless of imaging modality. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, inflammatory breast disease, and cystic lesions are all nonmeasurable.
up to a year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Paul B. Chapman, MD、Memorial Sloan Kettering Cancer Center
  • 首席研究员:Lauren E. Abrey, MD、Memorial Sloan Kettering Cancer Center
  • 首席研究员:Robert J. Motzer, MD、Memorial Sloan Kettering Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年3月1日

初级完成 (实际的)

2008年8月1日

研究完成 (实际的)

2008年8月1日

研究注册日期

首次提交

2007年4月18日

首先提交符合 QC 标准的

2007年4月18日

首次发布 (估计)

2007年4月19日

研究记录更新

最后更新发布 (估计)

2015年12月30日

上次提交的符合 QC 标准的更新

2015年11月24日

最后验证

2015年11月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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