NCT00014248已完成1 期
A Phase I Study And Pharmacokinetics Of Adenosine 5'- Triphosphate (ATP) When Administered By Intravenous Infusion On A Multiple Weekly Dose Schedule To Patients With Advanced Malignancies (Solid Tumors)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Adenosine triphosphate may decrease weight loss and improve muscle strength in patients with advanced solid tumors.
PURPOSE: Phase I trial to study the effectiveness of adenosine triphosphate in controlling loss of weight and loss of muscle mass in patients who have advanced solid tumors.
详细描述
OBJECTIVES:
- Determine the individualized maximum tolerated dose of adenosine triphosphate in patients with advanced solid tumors.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Determine the effect of this regimen on quality of life of these patients.
- Determine the influence of this regimen on cancer cachexia in terms of weight change, percentage of body fat, voluntary muscle strength, and plasma markers in these patients.
- Determine the effect of this regimen on tumor burden in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive adenosine triphosphate (ATP) IV over 8 hours on day 0. Treatment repeats weekly for a total of 8 courses in the absence of disease progression or unacceptable toxicity.
Each patient receives escalating doses of ATP until the individual maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which the patient experiences at least grade 3 (at least grade 2 cardiac ischemia or arrhythmia) toxicity.
研究设计
- 研究类型
- Interventional
- 主要目的
- Supportive Care
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 or cytologically confirmed advanced solid tumor that is not curable by conventional therapy
- •Brain metastases allowed if adequately controlled with radiotherapy
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Karnofsky 60-100%
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count at least 100,000/mm^3
- •SGOT and SGPT no greater than 3 times normal
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance greater than 60 mL/min
- •BUN no greater than 25 mg/dL
- •Cardiovascular:
- •Adequate cardiovascular function
- •No congestive heart failure (New York Heart Association class III or IV heart disease)
- •No angina pectoris AND/OR
- •No significant arrhythmia
- •No myocardial infarction within the past 6 months
- •No clinically significant ischemic cardiac disease currently under treatment
- •No clinically significant conduction system disease in the absence of a pacemaker (e.g., sick sinus syndrome, or second or third degree atrioventricular block)
- •Adequate pulmonary function
- •No clinical evidence of acute chronic obstructive pulmonary disease
- •FEV1 at least 50% predicted
- •Arterial oxygen tension at least 90% by pulse oximetry and on breathing room air
- •No asthma OR
- •No evidence of more than 20% reversibility in FEV1 with albuterol therapy
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No history of severe adverse reaction to adenosine
- •No uncontrolled medical illness
- •No average daily pain scores of at least 5 on a simple Visual Analogue Self pain assessment (0-10) scale
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy and recovered
- •Not specified
- •At least 30 days since prior investigational therapy
- •At least 14 days since prior long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy
- •No concurrent long-term theophylline, dipyridamole, or dipyridamole/aspirin therapy
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
The study of Involvement of Adenosine Triphosphate in Sputum in Pathophysiology of AsthmaBronchial asthma, COPDJPRN-UMIN000035749Saitama Medical University215
已完成
1 期
A Possible Therapeutic Role for Adenosine During InflammationEndotoxemiaNCT00513110Radboud University Medical Center33
已完成
不适用
Study to Examine the Effects of ATP Supplementation on Muscle Excitability and Reaction Time During and Following a Repeated Sprint BoutMuscle Fatigue Caused by Repetitive Muscle ExerciseNCT02093611Metabolic Technologies Inc.42
撤回
2 期
A Short-Term Study to Examine the Effects of ATHX-105 Phosphate on Weight Loss and SafetyObesityNCT00735683Healios K.K.
已完成
不适用
To evaluate whether intravenous Adenosine would replace the need for inhaled nitric oxide (iNO) in the management of Persistent Pulmonary Hypertension of the Newborn (PPHN)eonatal Diseases: Persistant pulmonary hypertensionNeonatal DiseasesOther pulmonary heart diseasesISRCTN51768118Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK)9