카포시 육종 치료를 위한 프로프라놀롤 연구
소아 및 성인의 카포시 육종 치료를 위한 프로프라놀롤의 제2상 연구
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Shane McAllister, Md, Phd
- 전화번호: 612-301-2205
- 이메일: smcallis@umn.edu
연구 장소
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Mexico City, 멕시코, 14080
- 아직 모집하지 않음
- Instituto Nacional de Cancerologia
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연락하다:
- Patricia Volkow, MD
- 전화번호: 5255 51026450
- 이메일: pvolkowf@gmail.com
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수석 연구원:
- Patricia Volkow, MD
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Rio de Janeiro, 브라질, 20231-050
- 아직 모집하지 않음
- Instituto Nacional de Câncer José de Alencar
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연락하다:
- Fabio Leal, MD, PhD
- 전화번호: 552132076557
- 이메일: fabio.leal@inca.gov.br
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Salvador, 브라질
- 아직 모집하지 않음
- Complexo Hospitalar Universitário Professor Edgard Santos
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연락하다:
- Carlos Brites, PhD
- 전화번호: 55 (71) 3283-8123
- 이메일: crbrites@gmail.com
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Buenos Aires, 아르헨티나
- 모병
- Fundación Huésped
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연락하다:
- Maria Jose Rolon, MD
- 전화번호: 541148082627
- 이메일: mjrolon@gmail.com
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Kampala, 우간다
- 아직 모집하지 않음
- Uganda Cancer Institute
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연락하다:
- Jackson Orem, MD
- 전화번호: +256 414540 410
- 이메일: jacksonorem@yahoo.co.uk
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수석 연구원:
- Jackson Orem, MD
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Harare, 짐바브웨
- 아직 모집하지 않음
- University of Zimbabwe College of Health Sciences
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연락하다:
- Margaret Borok, MBChB, FRCP
- 전화번호: +263 (242) 791-631
- 이메일: mborok@mweb.co.zw
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수석 연구원:
- Margaret Borok, MBChB (Hons) FRCP(UK)
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Objective Response Rate
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of dose-limiting toxicities
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
수사관
- 연구 의자: Shane McAllister, Md, PhD, University of Minnesota Medical School Department of Pediatrics
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 (실제)
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
- AMC-116
- UM1CA121947 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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