Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Weight is measured at baseline and at weeks 1-8, 10, and 13. Percentage of body fat and skeletal muscle strength is measured at baseline and at weeks 2, 4, 8, 10, and 13. Quality of life is assessed at baseline and at weeks 2, 4, 8, 10, and 13. Patients are followed at weeks 10 and 13. PROJECTED ACCRUAL: A maximum of 13-24 patients will be accrued for this study.

Official Title
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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)

Conditions
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Cachexia, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: adenosine triphosphate
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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: Age: Over 18 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 Hepatic: SGOT and SGPT no greater than 3 times normal Bilirubin no greater than 2.0 mg/dL Renal: 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) Pulmonary: 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 Other: 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 Surgery: Not specified Other: 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 No concurrent maintenance anti-anginal drug therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adenosine triphosphate|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, cachexia