- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00884598
Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer (CIRAB)
Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
RATIONALE: Cilengitide may stop the growth of brain metastases by blocking blood flow to the tumor. Radiation therapy uses high energy X-rays to kill tumor cells. Giving cilengitide together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide when given together with whole-brain radiation therapy in treating patients with brain metastases from lung cancer.
연구 개요
상세 설명
OBJECTIVES:
Primary
- To assess the safety and tolerability of daily cilengitide by determining its dose-limiting toxicity and maximum-tolerated dose when combined with concomitant fractionated whole-brain radiation therapy in patients with brain metastases from lung cancer.
Secondary
- To collect evidence of the best overall response rate, overall survival, brain-specific progression-free survival, and tumor-specific progression-free survival of these patients.
- To collect evidence of changes in functional MRI imaging studies at 6 and 12 weeks after initiation of therapy.
- To collect evidence of early response by functional MRI (ASL technique) on days 1, 4, and 12, immediately before and after the administration of cilengitide.
- To collect evidence of changes in neurological and neurocognitive function tests at 6 and 12 weeks after initiation of therapy.
- To further evaluate the safety and toxicity of the combination of cilengitide and whole-brain radiation therapy.
- To further evaluate the pharmacokinetics of cilengitide administered daily.
OUTLINE:
Patients receive oral cilengitide once daily and undergo whole-brain radiotherapy on the same days. Treatment continues for 2 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection on days 1, 4, 5, and 12 for pharmacokinetic studies.
After completion of study treatment, patients are followed for 10 weeks.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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Mannheim, 독일, D-68167
- 모병
- University Medical Center, Department of Surgery
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연락하다:
- Christian Manegold, MD
- 전화번호: 49-621-383-2199
- 이메일: prof.manegold@t-online.de
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
DISEASE CHARACTERISTICS:
- Histologically confirmed lung cancer (small cell or non-small cell lung cancer)
- Patient must be eligible for whole-brain radiotherapy
- Presence of brain metastasis (single or multiple, synchronous or metachronous) from lung cancer not amenable to surgery or radiosurgery (presence of metastases at any other site is allowed)
- No leptomeningeal metastasis or known subarachnoid spread of tumor
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-1 (ECOG PS 2 allowed if due to the presence of cerebral metastases and not due to a high peripheral-tumor load or other reasons)
- Life expectancy ≥ 3 months
- Adequate hematologic function
- Total bilirubin < 1.5 times upper limit of normal (ULN)
- AST, ALT, and alkaline phosphatase < 2.5 times ULN
- Creatinine clearance > 60 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study treatment
- No history of acute or chronic renal disease
- No other malignancies treated within the past 5 years, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
- No uncontrolled hypertension
- No history of coagulation disorder associated with bleeding or recurrent thrombotic events
- No peptic ulcer disease within the past 6 months
- No congestive heart failure, high risk for uncontrolled arrhythmia, or history of clinically significant coronary heart disease
- No known alcohol or drug abuse
- No other significant or acute concomitant disease
- No dementia or altered mental status
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent corticosteroids allowed if the dosing regimen has ben stable ≥ 5 days
- Concurrent anticonvulsants allowed if the dosing regimen has been stable for the past week
- More than 30 days since prior participation in another clinical trial
- No concurrent anticoagulation with vitamin K antagonists, therapeutic-dose anticoagulation with heparin resulting in prolonged PTT, or therapeutic-dose anticoagulation with low molecular weight heparin (low-dose [i.e. prophylactic], low molecular weight heparins allowed)
- No prior whole-brain radiation or radiosurgery
- No prior antiangiogenic therapy
- No other concurrent anticancer therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
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최대 허용 용량
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용량 제한 독성
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2차 결과 측정
결과 측정 |
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전반적인 생존
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전체 응답률
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Brain-specific progression-free survival (PFS)
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Tumor-specific PFS
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Changes in functional MRI imaging studies at 6 and 12 weeks
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Evidence of early response by functional MRI on days 1, 4, and 12
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Changes of neurological and neurocognitive function tests at 6 and 12 weeks
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Safety and toxicity of the combination of cilengitide and whole-brain radiation therapy
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Pharmacokinetics of cilengitide
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공동 작업자 및 조사자
수사관
- 수석 연구원: Christian Manegold, MD, University Medical Center Mannheim
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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 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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