出血性膀胱炎に対するシドフォビルと最良の支持療法の比較
幹細胞移植後のポリオーマウイルス ホミニス I 型（BK）ウイルス関連出血性膀胱炎に対するシドフォビルとベスト サポーティブ ケアの第 II 相ランダム化試験
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Texas
-
Houston、Texas、アメリカ、77030
- University of Texas MD Anderson Cancer Center
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
|
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Patients with Microbiologic Response
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Borje S. Andersson, MD,PHD、M.D. Anderson Cancer Center
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2010-0518
- NCI-2011-00250 (レジストリ識別子：NCI CTRP)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。