Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
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.
|Cachexia Unspecified Adult Solid Tumor, Protocol Specific||Drug: adenosine triphosphate Procedure: quality-of-life assessment||Phase 1|
|Study Design:||Primary Purpose: Supportive Care|
|Official Title:||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)|
|Study Start Date:||October 2000|
|Primary Completion Date:||November 2002 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014248
|United States, New Hampshire|
|Norris Cotton Cancer Center|
|Lebanon, New Hampshire, United States, 03756-0002|
|Study Chair:||Lionel D. Lewis, MD||Norris Cotton Cancer Center|