출혈성 방광염에 대한 Cidofovir 대 최상의 지지 요법
줄기세포 이식 후 폴리오마바이러스 호미니스 I형(BK) 바이러스 관련 출혈성 방광염에 대한 Cidofovir 대 최상의 지지 요법의 제2상 무작위 연구
The goal of this clinical research study is to learn if adding cidofovir to the standard of care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to standard of care alone. The safety of cidofovir will also be studied.
연구 개요
상세 설명
The Study Drug:
Cidofovir is an anti-viral drug that is designed to treat or prevent infections caused by certain kinds of viruses.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups and you will have an equal chance of being in either group:
- If you are in Group 1, you will receive standard of care drugs and cidofovir. The doctor will tell you more about the standard of care drugs that you will take and the risks for them.
- If you are in Group 2, you will only receive standard of care drugs.
Study Drug Administration:
If you are in Group 1, you will receive cidofovir by vein over about 1 hour 3 times per week. You will also receive standard of care, which may include oral pain drugs taken every 4 to 6 hours as needed, oral drugs for urinary urgency taken 2 times daily, and fluids given by vein to increase your urination rate.
If you are in Group 2, you will only receive the standard of care, as described above.
Study Visits:
Each week:
- Blood (about 2 tablespoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs.
Every 2 weeks, you will complete the questionnaire about urinary problems.
Length of Study:
If you are in Group 1, you may continue taking the study drug for up to 4 weeks. Group 2 will take the standard of care for 4 weeks. If the doctor thinks it is needed Groups 1 and 2 can continue to receive standard of care after this study is over. If your symptoms get worse during the study and you are not receiving cidofovir, you may be eligible for further treatments, which may include cidofovir, after the study ends. You will no longer be able to take the study drug if the disease gets worse or intolerable side effects occur.
Your participation on the study will be over once you have completed the end-of-treatment visit and the follow-up visit.
End-of-Treatment Visit:
After you finish treatment:
- Urine will be collected to test the level of BK virus.
- You will complete the questionnaire about urinary problems.
Follow-up Visit:
Four (4) weeks after treatment ends:
- You will have a physical exam, including measurement of your vital signs.
- Urine will be collected to test the level of BK virus.
This is an investigational study. Cidofovir is FDA approved and commercially available for the treatment of several viral infections. Its use in patients with the BK virus after a stem cell transplant is investigational.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Texas
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Houston, Texas, 미국, 77030
- University of Texas MD Anderson Cancer Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- HSCT patients with symptomatic hemorrhagic cystitis (minimal Grade 1 symptoms of HC per NCI criteria) and positive BKV in urine >1x103 DNA copies/ml
- Age >/= 6 years
- Patient must sign the informed consent document.
Exclusion Criteria:
- Creatine clearance < 55 ml/min, calculated using ideal body weight (IBW) using Cockcroft-Gault equation
- Concomitant use of foscarnet, liposomal amphotericin B or aminoglycoside
- Use of cidofovir for bladder instillation
- Use of formalin or hyperbaric oxygen treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Standard of Care + Cidofovir
Cidofovir 0.5 mg/kg IV 3 x week for 4 weeks |
0.5 mg/kg by vein (IV) 3 times a week for 4 weeks.
다른 이름들:
|
|
활성 비교기: No Cidofovir
Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation. |
Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Patients with Microbiologic Response
기간: 8 weeks
|
Response defined as improvement in symptoms based on questionnaire, reduction or stability in grade of hemorrhagic cystitis, and level of virus must be a 1 log reduction from baseline when the BKV was first diagnosed. |
8 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Borje S. Andersson, MD,PHD, M.D. Anderson Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2010-0518
- NCI-2011-00250 (레지스트리 식별자: NCI CTRP)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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