A Phase II Clinical Trial of Angiotensin 1-7 For the Second or Third Line Treatment of Patients With Metastatic or Unresectable Sarcomas
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
研究概览
简要总结
This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor.
Funding Source - FDA Office of Orphan Drug Products (OOPD)
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the response rate of chemotherapy-refractory sarcomas to 20 mg per day of single-agent Ang(Angiotensin)-(1-7) or 10 mg per day of single-agent Ang-(1-7) if excessive toxicity is observed at the 20 mg dose.
II. To evaluate toxicities associated with single-agent Ang-(1-7) when given to patients with chemotherapy-refractory sarcomas.
SECONDARY OBJECTIVES:
I. To assess time to progression (TTP) and overall survival (OS) in patients treated with Ang-(1-7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Patients must have a histologically or cytologically confirmed sarcoma that is metastatic or unresectable and have progressed despite 1 or 2 prior treatment regimens with chemotherapy or targeted anti-cancer agents such as imatinib
- •Prior treatment: >= 4 weeks since completion of radiation or chemotherapy, except for >= 6 weeks for Melphalan, nitrosoureas, or mitomycin-C
- •Eastern Cooperative Oncology Group (ECOG) performance status =< 2
- •Absolute neutrophil count >= 1,500/Microliter (mcL)
- •Platelets >= 100,000/mcL
- •Total bilirubin =< 2 mg/dL
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) < 3 X upper limit or normal (ULN)
- •Estimated (est.) creatinine clearance > 30 mL/min
- •Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as > 10 mm
- •Women of child-bearing potential and men must agree to use adequate contraception (hormonal or double-barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients may not be receiving any other investigational agents for cancer treatment
- •Patients with evidence of bleeding diathesis are ineligible
- •No concurrent treatment with angiotensin-converting-enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs)
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension or hypotension, or psychiatric illness/social situations that would limit compliance with study requirements
- •Pregnant and nursing women are excluded from this study
研究组 & 干预措施
Treatment (antiangiogenesis therapy)
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
干预措施: therapeutic angiotensin-(1-7) (Drug)
Treatment (antiangiogenesis therapy)
Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Antitumor Activity as Assessed by Number of Patients Showing an Objective Tumor Response
时间窗: Approximately 1 year
'Activity' will be operationalized using objective tumor response, which will be estimated as the proportion of partial and complete responders (according to Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) among all evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of Participants Who Experienced Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
时间窗: Approximately 1 year
See the adverse event tables for specifics.
次要结局
- Plasma Levels of Angiogenic Peptides Including Placental Growth Factor (PlGF)(Baseline and Day 22)
- Time to Disease Progression(Approximately 5 years)
- Overall Survival(Approximately 5 years)