- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00462982
Sunitinib in Treating Patients With Brain Metastases Caused by Kidney Cancer or Melanoma
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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New York
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New York, New York, 미국, 10021
- Memorial Sloan-Kettering Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Sunitinib
Patients will be treated with 50 mg daily for four out of every six weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Central Nervous System (CNS) Response Rate by RECIST Criteria
기간: up to a year
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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
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paul B. Chapman, MD, Memorial Sloan Kettering Cancer Center
- 수석 연구원: Lauren E. Abrey, MD, Memorial Sloan Kettering Cancer Center
- 수석 연구원: Robert J. Motzer, MD, Memorial Sloan Kettering Cancer Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 07-009
- P30CA008748 (미국 NIH 보조금/계약)
- MSKCC-07009
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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