뼈 전이 완화에 대한 방사선 요법 및 졸레드론산 병용의 안전성 및 효능 연구
2010년 12월 20일 업데이트: The Cleveland Clinic
유방암, 전립선암 및 폐암의 뼈 전이 완화를 위한 병용 방사선 요법 및 졸레드론산의 안전성 및 효능을 연구하기 위한 1상 예비 시험
졸레드론산(Zometa)은 비스포스포네이트라고 불리는 약물 종류에 속합니다.
비스포스포네이트는 뼈 전이에 사용되어 뼈의 암 병변을 통제하고 혈중 칼슘 수치 상승을 방지하는 데 도움이 됩니다.
클리블랜드 클리닉(Cleveland Clinic)의 암세포 배양 연구에서 졸레드론산과 방사선을 함께 사용하면 단독으로 사용하는 것보다 더 많은 세포 살상 효과가 있는 것으로 나타났습니다.
본 연구의 목적은 방사선 치료와 함께 졸레드론산을 사용할 때 뼈 병변의 치유를 모니터링하는 것입니다.
연구 개요
상세 설명
뼈 전이는 종종 암 환자의 파종성 질병의 첫 징후 중 하나입니다. 전이성 질환으로 인한 골격 합병증에는 (심각한) 뼈 통증, 운동 장애, 척수 압박, 병적 골절 및 고칼슘혈증이 포함됩니다. 방사선 요법과 수술은 뼈 전이의 특정 국소 치료를 위한 옵션입니다. 화학요법, 호르몬요법 및 비스포스포네이트는 고칼슘혈증이 있거나 없는 뼈 전이 치료에 사용되는 전신 무기입니다. 유방, 전립선, 폐 및 골수종과 같이 뼈로 전이되는 경향이 있는 암은 파골 세포와 상호 작용할 수 있는 능력을 가질 수 있습니다. 파골 세포는 산과 리소좀 효소를 분비하여 광물화된 뼈를 침식하는 특화된 뼈 세포입니다. 정상적인 뼈 재형성에서 파골세포의 뼈 재흡수는 조골세포의 뼈 형성과 결합되어 균형을 이룹니다. 악성 골 전이와 관련된 용해성 골 파괴는 종양 세포가 파골 세포를 자극하여 골을 재흡수하도록 하는 용해성 인자를 합성 및 방출하기 때문에 발생합니다. 파골 세포의 악성 활성화는 정상적인 골 재형성을 방해하여 골 재흡수와 골 형성 사이의 균형이 골 재흡수 증가 쪽으로 이동합니다. 파골세포 골 흡수의 상대적인 증가는 뼈의 순 손실을 초래합니다.
졸레드론산(Zometa®, CGP42446)은 비스포스포네이트로 알려진 화합물 부류의 구성원입니다. 비스포스포네이트는 파골세포 골 흡수의 효과적인 억제제입니다. 이들은 악성 종양의 고칼슘혈증, 다발성 골수종과 관련된 용해성 골 질환, 유방암, 전립선암 및 폐암과 관련된 혼합 용해성 및 모세포성 골 전이의 치료에 치료 효능이 있습니다. 임상 환경에서 졸레드론산은 가장 강력한 비스포스포네이트입니다.
전통적으로 외부 빔 방사선 요법(RT)은 뼈 전이의 완화를 위한 1차 치료 방법입니다. 뼈 전이 치료에서 RT의 목표는 주변 정상 세포를 손상시키지 않고 악성 세포를 박멸하는 것입니다. RT는 가능한 한 많은 골수를 보존하기 위해 일반적으로 병변 부위에 제공됩니다. RT는 골절 위험을 예방하거나 통증을 완화하기 위해 유방암, 전립선암 및 폐암과 같은 고형 종양의 골 전이뿐만 아니라 다발성 골수종의 고립성, 용해성 및 통증성 골 병변에 표시됩니다.
이 연구의 목표는 유방암, 전립선암 또는 폐암 환자의 뼈 전이에 대한 병용 표준 RT 및 표준 졸레드론산의 안전성과 효능을 평가하는 것입니다. 우리는 이 연구에서 사용하기 위해 zoledronic acid가 가장 효과적인 FDA 승인 aminobisphosphonate이기 때문에 선택했습니다.
연구 유형
중재적
등록 (실제)
4
단계
- 1단계
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
포함 기준:
- 18세 이상
- 생검으로 입증된 유방암, 폐암 및/또는 전립선암
- 방사선학적으로 진단되거나 생검으로 입증된 방사선 징후가 있는 뼈 전이
- Karnofsky 성능 상태 >60
- 기대 수명 최소 6개월
- 혈청 크레아티닌 수치 ≤ 2.0 mg/dL 및 계산된 크레아티닌 청소율 > 60 mL/min
- 백혈구 수 ≥ 3500/mm3
- 헤모글로불린 > 11g/dl
- 혈소판 > 100,000/mm3
- 총 빌리루빈 < 2.5mg/dl
제외 기준:
- 임산부 및 수유부(유방암 및 폐암)
- 무작위 배정 전 3개월 이내에 시작된 호르몬 요법(전립선암)
- 비스포스포네이트에 대한 알레르기 반응의 병력
- 병용 신 독성 화학 요법을 받고
- 지난 30일 이내에 연구 약물로 다른 임상 시험에 참여했거나 연구 약물 시험을 완료했습니다.
- 간 기능 검사 > 정상 수치의 1.5배
- 무작위화 전 30일 미만의 IV 칼시토닌 투여
- 신장 질환의 실험실 증거
- 이 연구에서 치료할 뼈 전이 영역에 대한 이전 RT
- 현재 경구 또는 IV 비스포스포네이트 요법을 받고 있는 자
- 복수의 존재
- 임상적으로 중요한 심전도 변화
- 고칼슘혈증, 병적 골절 또는 경막외 척수 압박
- 다른 장기 전이
- Zometa®(졸레드론산) 또는 기타 비스포스포네이트에 대해 알려진 과민성
- 치아 또는 턱뼈(상악골 또는 하악골)의 감염을 포함한 현재 진행 중인 치과 문제; 치과 또는 고정 장치 외상, 턱의 골괴사증(ONJ), 구강 내 노출된 뼈 또는 치과 시술 후 느린 치유의 현재 또는 이전 진단.
- 최근(6주 이내) 또는 예정된 치과 또는 턱 수술(예: 발치, 임플란트)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
졸레드론산 + 방사선 요법
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기준선에서 15분에 걸쳐 4 mg IV 졸레드론산.
6개월 동안 4주마다 방사선 요법 10분할로 30Gy(처음 2주 동안 주당 5회)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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PET-CT
기간: 기본 및 6개월
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기본 및 6개월
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2차 결과 측정
결과 측정 |
기간 |
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엑스레이, 베이스라인
기간: 3개월, 6개월
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3개월, 6개월
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신체 검사
기간: Radiaton 종양학 - 방문 1, 14, 17
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Radiaton 종양학 - 방문 1, 14, 17
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신체 검사
기간: 종양학 - 방문 1, 13, 17
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종양학 - 방문 1, 13, 17
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen Breast Cancer...완전한
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University of UtahNational Cancer Institute (NCI)모병피로 | 좌식 생활 | 전이성 전립선암 | IV기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVA기 전립선암 AJCC(American Joint Committee on Cancer) v8 | IVB기 전립선암 AJCC(American Joint Committee on Cancer) v8미국
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Jonsson Comprehensive Cancer Center아직 모집하지 않음전립선암 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Rashmi Verma, MDNational Cancer Institute (NCI)모병거세저항성 전립선암 | 전이성 전립선 선암종 | IVB기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center빼는전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer CenterMiraDX모집하지 않고 적극적으로전립선 선암종 | 2기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer Center종료됨거세저항성 전립선암 | 전이성 전립선암 | IVA기 전립선암 AJCC v8 | IVB기 전립선암 AJCC v8 | IV기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.종료됨2기 전립선암 AJCC v8 | IIIA기 전립선암 AJCC v8 | IIIB기 전립선암 AJCC v8 | IIC기 전립선암 AJCC v8 | 3기 전립선암 AJCC v8 | IIIC기 전립선암 AJCC v8 | IIA기 전립선암 AJCC v8 | IIB기 전립선암 AJCC v8 | 1기 전립선암 American Joint Committee on Cancer(AJCC) v8미국
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Assiut University아직 모집하지 않음South Egypt Cancer Institute(SECI)에서 소아 악성종양 환자에 대한 KDIGO 기준을 사용하여 AKI의 누적 발병률을 확인하기 위해
졸레드론산에 대한 임상 시험
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co...완전한
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National University of Ireland, Galway, IrelandStanley Medical Research Institute완전한
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Daewoong Pharmaceutical Co. LTD.완전한
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University Hospital, Akershus모병
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University Hospital, Basel, Switzerland완전한
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University College, LondonImperial College London; Cancer Research UK; National Cancer Imaging Translational Accelerator모병
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Massachusetts General Hospital완전한