An Open-Label Pilot Phase 2 Study to Investigate Efficacy, Safety, and Intratumoral Kinetics of ALDOXORUBICIN in HIV-Infected Patients With Kaposi's Sarcoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population
研究概览
简要总结
This is a pilot study to determine the efficacy, kinetics and safety of aldoxorubicin in HIV positive subjects with Kaposi's sarcoma.
详细描述
This is an open-label pilot phase 2 study to investigate efficacy, safety, and intratumoral kinetics of aldoxorubicin in HIV-Infected patients with Kaposi's sarcoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years of age; male or female.
- •HIV (confirmed by ELISA and western blot) with histologically confirmed KS.
- •Willing to undergo serial tumor biopsies.
- •Capable of providing informed consent and complying with trial procedures.
- •KPS ≥70 (Appendix B)
- •Easter Cooperative Oncology Group (ECOG) PS 0-
- •Life expectancy ≥ 8 weeks.
- •Measurable (at accessible site or radiographic) tumor lesions according to ACTG TIS criteria.
- •Women must not be able to become pregnant (e.g. post-menopausal for at least 1 year, surgically sterile, or practicing adequate birth control methods) for the duration of the study. (Adequate contraception includes: oral contraception, implanted contraception, intrauterine device implanted for at least 3 months, or barrier method in conjunction with spermicide.)
- •Women of child bearing potential must have a negative serum or urine pregnancy test at the Screening Visit and be non-lactating.
- •Geographic accessibility to the site.
排除标准
- •Prior exposure to an anthracycline.
- •Surgery and/or radiation treatment < 4 weeks prior to Randomization.
- •Exposure to any investigational agent within 30 days of Randomization.
- •History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥3 years.
- •Laboratory values: Screening serum creatinine >1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) > 2.5 × ULN, total bilirubin >1.5 × ULN, absolute neutrophil count (ANC) <1,500/mm3, platelet concentration <75,000/mm3, absolute lymphocyte count <1000/mm3, hematocrit level <25% for females or <27% for males, serum albumin ≤2.5 g/dL.
- •Evidence of central nervous system (CNS) hemorrhage National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (published 28 May 2009) grade 2 or greater on baseline MRI.
- •Clinically evident congestive heart failure (CHF) > class II of the New York Heart Association (NYHA) guidelines.
- •Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
- •History or signs of active coronary artery disease with or without angina pectoris.
- •Serious myocardial dysfunction defined as ultrasound-determined absolute left ventricular ejection fraction (LVEF) <45% of predicted institutional normal value.
- •Active, clinically significant serious infection requiring treatment with antibacterial, antiviral (other than antiretroviral therapy), or antifungal therapy.
- •Major surgery within 4 weeks prior to Randomization.
- •Any condition that might interfere with the subject's participation in the study or in the evaluation of the study results.
- •Any condition that is unstable and could jeopardize the subject's participation in the study.
研究组 & 干预措施
50 mg/m2 aldoxorubicin
干预措施: 50 mg/m2 aldoxorubicin (Drug)
100 mg/m2 aldoxorubicin
干预措施: 100 mg/m2 aldoxorubicin (Drug)
150 mg/m2 aldoxorubicin
干预措施: 150 mg/m2 aldoxorubicin (Drug)
结局指标
主要结局
Number of Participants With Treatment-related Toxicities (Adverse Events) in This Subject Population
时间窗: 30 days from last dose, up to 199 days
All subjects who receive any amount of ALDOXORUBICIN will be included in the safety analyses, which will include the following: The incidence, severity, duration, causality, seriousness, and type of AEs and changes in the subject's physical examination, vital signs, and clinical laboratory results. * vitals signs (systolic/diastolic blood pressure, pulse, respiration, temperature, weight, and body surface area) * physical examination * laboratory tests (chemistry, hematology, urinalysis, anion gap)
Objective Response Rate
时间窗: up to 6 months
To evaluate the uptake of aldoxorubicin into the tumor and the objective response rate (complete and partial response) using RECIST 1.1 criteria in subjects with HIV-infected with Kaposi's sarcoma. Objective responses will be evaluated using the RECIST 1.1 criteria. Changes (i.e. improvements) in tumor measurements from baseline values will be assigned a status of CR or PR or SD. Objective response measurements will comprise the sum of CR plus PR. Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm). Partial Response (PR): 30% decrease in the sum of the longest diameter of target lesions, from the baseline sum longest diameter.
次要结局
未报告次要终点