NCT01147029终止1 期
A Cancer Research UK Phase I Trial of 4-(N-(S-Glutathionylacetyl) Amino) Phenylarsenoxide (GSAO) Given as Daily Intravenous Infusions on Days 1-5 and 8-12 of a 21-Day Cycle, to Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Dose-limiting toxicity
研究概览
简要总结
RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating patients with advanced solid tumors that have not responded to therapy.
详细描述
OBJECTIVES:
Primary
- To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors.
- To assess the safety and toxicity profile and dose-limiting toxicity of this drug in these patients.
Secondary
- To determine the pharmacokinetics of this drug in these patients.
- To determine the pharmacodynamics of this drug in these patients.
- To determine possible anti-tumor activity in patients treatment with this drug.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed advanced solid tumor
- •Refractory to conventional treatment or for which no conventional therapy exists
- •Disease assessable by DCE-MRI and should be of a size that can be adequately assessed by these techniques
- •No known primary brain tumors or brain metastases
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-1
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 9.0 g/dL
- •Platelet count ≥ 100 x 10^9/L
- •Neutrophil count ≥ 1.5 x 10^9/L
- •Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 times ULN
- •Creatinine clearance ≥ 50 mL/min (uncorrected value)
- •Serum potassium and magnesium normal
- •No proteinuria > grade 1 either on 24-hour urine or on 2 consecutive dipsticks taken no less than 1 week apart
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception 4 weeks prior to, during, and for 6 months after completion of study therapy
- •Not at high medical risk due to non-malignant systemic disease, including active uncontrolled infection
- •No serologically positive hepatitis B, hepatitis C, or HIV
- •No concurrent congestive heart failure or prior NYHA class III-IV cardiac disease
- •None of the following medical conditions:
- •Angina (stable or severe, even if well controlled on medication)
- •Myocardial infarction in the past 2 months by ECG
- •Congestive cardiac failure
- •Arrhythmias, including any condition associated with QTc prolongation (e.g., Lange-Neilson syndrome or Romano Ward syndrome)
- •Evidence of ischemia
- •QTc > 480 msec
- •Other clinically significant abnormalities
- •No uncontrolled hypertension (defined as BP consistently greater than 160/100 mm Hg irrespective of medication)
- •No other condition that, in the opinion of the investigator, would not make the patient a good candidate for this clinical trial
- •No pacemakers
- •No metal fragments in the eyes or shrapnel or bullet injuries
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from all prior treatments (except for alopecia or certain grade 1 toxicities which, in the opinion of the investigator and Cancer Research UK, should not exclude the patient)
- •At least 4 weeks since prior radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, or chemotherapy (6 weeks for nitrosoureas and mitomycin C)
- •At least 1 week since prior and no concurrent shellfish
- •At least 6 weeks since prior major surgery (including thoracic and/or abdominal surgery) and recovered
- •Concurrent luteinizing-hormone releasing-hormone (LHRH) analogues allowed for patients with castration-refractory prostate cancer provided the prostate-specific antigen level is rising
- •No prior heart or brain surgery
- •No concurrent drug known to prolong the QTc interval
- •No concurrent warfarin (1 mg for maintenance of a Hickman line is acceptable) or heparin (flushing of arterial lines, if necessary, is acceptable)
- •No concurrent naproxen (other NSAIDs are acceptable)
- •No concurrent prophylactic use of antiemetics during the first treatment
- •Domperidone and lorazepam must not be used as antiemetics
- •No other concurrent anticancer therapy or investigational drugs
- •Concurrent bisphosphonates allowed
排除标准
- 未提供
结局指标
主要结局
Dose-limiting toxicity
Causality of each adverse event and grading severity according to NCI CTCAE Version 3.0
次要结局
- Relationship between pharmacokinetics and toxicity and/or markers of efficacy
- Changes in microvascular function using DCE-MRI
- Plasma and tumor levels of angiogenic factors and apoptosis markers
- Response (stable disease, partial response, or complete response) as determined by RECIST criteria
- Circulating endothelial cells and circulating endothelial progenitor cells as a marker of inhibition of angiogenesis
研究者
研究点 (4)
Loading locations...
相似试验
终止
1 期
NG-Nitro-L-Arginine in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT01324115Cancer Research UK6
Unknown
1 期
SU006668 in Treating Patients With Advanced Solid TumorsKidney CancerMultiple Myeloma and Plasma Cell NeoplasmProstate CancerColorectal CancerPancreatic CancerBreast CancerLung CancerGastric CancerNCT00024063Jonsson Comprehensive Cancer Center
已完成
1 期
SU5416 in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00005642Case Comprehensive Cancer Center19
已完成
1 期
S-3304 in Treating Patients With Advanced Solid TumorsUnspecified Adult Solid Tumor, Protocol SpecificNCT00033566Roswell Park Cancer Institute
已完成
1 期
SU5416 and Paclitaxel in Treating Patients With Advanced CancerUnspecified Adult Solid Tumor, Protocol SpecificNCT00006257City of Hope Medical Center