カポジ肉腫を治療するためのプロプラノロールの研究
小児および成人におけるカポジ肉腫の治療のためのプロプラノロールの第II相試験
A clinical study of propranolol for the treatment of Kaposi Sarcoma in children and adults. This study will be an open-label single armed treatment trial that will test the effectiveness and the safety of treating Kaposi Sarcoma with propranolol.
調査の概要
詳細な説明
Eligible study participants will receive propanolol twice daily for an initial 12-week period. At the conclusion of 12-weeks, response will be assessed. Participants who achieve a complete or partial response will continue propanolol for an additional 6 weeks or 12 weeks, respectively.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Shane McAllister, Md, Phd
- 電話番号：612-301-2205
- メール：smcallis@umn.edu
研究場所
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Buenos Aires、アルゼンチン
- 募集
- Fundación Huésped
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コンタクト：
- Maria Jose Rolon, MD
- 電話番号：541148082627
- メール：mjrolon@gmail.com
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Kampala、ウガンダ
- まだ募集していません
- Uganda Cancer Institute
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コンタクト：
- Jackson Orem, MD
- 電話番号：+256 414540 410
- メール：jacksonorem@yahoo.co.uk
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主任研究者：
- Jackson Orem, MD
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Harare、ジンバブエ
- まだ募集していません
- University of Zimbabwe College of Health Sciences
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コンタクト：
- Margaret Borok, MBChB, FRCP
- 電話番号：+263 (242) 791-631
- メール：mborok@mweb.co.zw
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主任研究者：
- Margaret Borok, MBChB (Hons) FRCP(UK)
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Rio de Janeiro、ブラジル、20231-050
- まだ募集していません
- Instituto Nacional de Câncer José de Alencar
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コンタクト：
- Fabio Leal, MD, PhD
- 電話番号：552132076557
- メール：fabio.leal@inca.gov.br
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Salvador、ブラジル
- まだ募集していません
- Complexo Hospitalar Universitário Professor Edgard Santos
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コンタクト：
- Carlos Brites, PhD
- 電話番号：55 (71) 3283-8123
- メール：crbrites@gmail.com
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Mexico City、メキシコ、14080
- まだ募集していません
- Instituto Nacional de Cancerologia
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コンタクト：
- Patricia Volkow, MD
- 電話番号：5255 51026450
- メール：pvolkowf@gmail.com
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主任研究者：
- Patricia Volkow, MD
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
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Pediatric (< 18 years) and adult (≥ 18 years) participants with biopsy-proven and measurable Kaposi Sarcoma (KS) as defined in the KS Manual of Procedures (MOP).
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No urgent clinical indication for immediate cytotoxic chemotherapy. Participants who have received cytotoxic chemotherapy > 4 weeks prior to screening are eligible.
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KS stage:
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< 18 years:
- 1A (Mild): disease limited to skin, flat oral mucosal lesions, and/or flesh colored subcutaneous nodules, total <10 lesions.
- 1B (Moderate): having any of the following features, alone or in combination: a total of 10-19 hyperpigmented skin/oral lesions, nodular oral involvement, conjunctival eye involvement, or exophytic mass.
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≥ 18 years:
- T0: confined to skin and/or lymph nodes and/or minimal oral lesions.
- T1: limited to tumor-associated edema of cutaneous lesions without functional impairment or flat oral lesions.
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Performance Status:
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< 18 years:
- Lansky performance status > 70%
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≥ 18 years:
- Easter Cooperative Oncology Group (ECOG) performance status ≤ 2
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Participants must have adequate organ function, as defined by the following:
- Bilirubin (direct or total) within normal range, or total bilirubin <3.0 mg/dl for participants with Gilbert syndrome.
- Calculated creatinine clearance ≥ 30 mL/min for participants ≥ 12 years (see Appendix III); creatinine <1.5 Upper Limit Normal (ULN) for participants < 12 years.
- Hemoglobin > 9 g/dL;
- Platelets > 100 × 109/L;
- ANC > 1000 cells/mm3
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Human Immunodeficiency Virus (HIV) positive participants must be on antiretroviral therapy (ART) that conforms to local standards of care. Participants will have been on ART for at least 12 weeks. Participants will not be excluded based on CD4 count or HIV viral load.
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HIV positive participants must not show recent improvement on ART that may confound response evaluation:
- If on ART 12 to 24 weeks, participants must show evidence of KS progression requiring further systemic treatment.
- If on ART for >24 weeks, must show no evidence of regression in the last eight weeks.
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HIV-negative participants must not show evidence of improvement in the three months prior to enrollment.
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No history of asthma or diabetes mellitus (as it is a risk factor for hypoglycemia).
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No clinically significant cardiovascular disease other than hypertension, which is permitted.
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No use of beta-adrenergic antagonists for other indications.
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Not pregnant or planning to become pregnant. Propranolol is United Stats Food and Drug Administration (US FDA) pregnancy category C. At this time, the study team has determined that the unknown risk to a developing fetus is greater than the potential benefit of treatment.
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Use of effective contraception for women of childbearing potential, defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months.
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Women of child bearing potential (WOCBP) must agree to use adequate contraception (oral contraceptive pills, intrauterine device, Nexplanon, Depo-Provera, or permanent sterilization, etc., or another acceptable method as determined by the investigator) prior to study entry, for the duration of study participation.
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Not breast feeding.
Exclusion Criteria:
• Participants who do not fulfill the criteria as listed in Section 3.1 above, are ineligible. Additionally, the presence of any of the following conditions will exclude a participant from study enrollment:
- Children and adolescents with lymph node or visceral disease, woody edema, or ≥ 20 cutaneous lesions.
- Children and adolescents with heart rate or systolic blood pressure <10th percentile for age.
- Adults with visceral disease or tumor-associated edema causing functional impairment.
- Shortness of breath, hemoptysis, or moderate/severe cough not attributable to causes other than KS.
- Bleeding from the mouth or rectum not attributable to causes other than KS.
- Treatment for active and serious infection.
- Children with severe acute malnutrition based on World Health Organization (WHO) criteria (Mid-upper arm circumference <11.5 cm, weight-for height Z-score <-3 or presence of symmetrical pitting edema).
- Given the risk of hypotension and hypoglycemia, participants must take the study drug with food. If needed, the study team will pursue additional funding to support providing supplemental food for participants who experience food insecurity.
- Patients who experienced hypersensitivity to propranolol during initiation phase of treatment or had previous known allergy to propranolol or allergy to other β-blockers.
- Patients with a history of uncompensated heart failure; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree.
- Patients with diagnosed obstructive airway disease such as asthma, chronic obstructive pulmonary disease (COPD), or bronchiolitis.
- History of diabetes mellitus (as it is a risk factor for hypoglycemia)
- Patients receiving concurrent treatment with an anticancer therapy. Patients must not have received any anticancer therapies within 30 days prior to receiving the first dose of investigational treatment.
- Patients with concern for Kaposi Sarcoma herpesvirus (KSHV) inflammatory cytokine syndrome.
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：なし
- 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 |
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実験的：Propranolol
Propranolol Twice Daily (BID) x 12 weeks Dosage: For ages ≤ 12 years: 3mg/kg/day divided BID; for ages > 12 years, 120 mg BID. |
Adults: Propanolol 120 mg tablets by mouth twice daily for up to 24 weeks Children: Propanolol 3 mg/kg suspension, divided dose twice daily for up to 24 weeks |
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 |
|---|---|---|
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Objective Response Rate
時間枠：At one year
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ORR is defined as the proportion of participants with complete response (CR), or partial response (PR) based on AIDS Malignancy Consortium Kaposi Sarcoma (AMC KS) Response Criteria. |
At one year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of dose-limiting toxicities
時間枠：At one year
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To evaluate the number of dose-limiting toxicities. The dose-limiting toxicities will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events |
At one year
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Number of treatment-emergent adverse events
時間枠：At one year
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To evaluate the number of treatment-emergent adverse events. The treatment-emergent adverse events will be based on the National Cancer Institute's Common Terminology Criteria for Adverse Events |
At one year
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Complete and Partial Response rates in children and adults
時間枠：At one year
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Proportion of children and adults with a Complete Response or Partial Response. |
At one year
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Time to recurrence among children
時間枠：At one year
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Time to recurrence among responders overall in children. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission. |
At one year
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Time to recurrence among adults
時間枠：At one year
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Time to recurrence among responders overall in adults. Recurrent disease is defined as the appearance of tumor following documentation of a complete remission. |
At one year
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Time to progression among children
時間枠：At one year
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Time to progression among responders overall in children. Time to progression is defined as time from initiation of propranolol to documentation of first progression. |
At one year
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Time to progression among adults
時間枠：At one year
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Time to progression among responders overall in adults. Time to progression is defined as time from initiation of propranolol to documentation of first progression. |
At one year
|
協力者と研究者
捜査官
- スタディチェア：Shane McAllister, Md, PhD、University of Minnesota Medical School Department of Pediatrics
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 (実際)
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
- AMC-116
- UM1CA121947 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国で製造され、米国から輸出された製品。
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