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Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
This study has been completed.
Sponsored by: | National Cancer Institute (NCI) Norris Cotton Cancer Center
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Information provided by: | National Cancer Institute (NCI) |
Purpose
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.
Condition | Treatment or Intervention | Phase |
---|---|---|
Cachexia unspecified adult solid tumor, protocol specific Quality of Life |
Procedure: supportive care Drug: nutritional support Procedure: anticachectic therapy Behavior: supportive care/therapy Procedure: quality-of-life assessment Drug: adenosine triphosphate |
Phase I |
MedlinePlus related topics: Cancer; Cancer Alternative Therapy
Study Type: Interventional
Study Design: Educational/Counseling/Training
Official Title: Phase I Study of Adenosine Triphosphate in Patients With Advanced Solid Tumors
Study start: October 2000
OBJECTIVES: I. Determine the individualized maximum tolerated dose of adenosine triphosphate in patients with advanced solid tumors. II. Determine the safety of this regimen in these patients. III. Determine the pharmacokinetics of this regimen in these patients. IV. Determine the effect of this regimen on quality of life of these patients. V. 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. VI. Determine the effect of this regimen on tumor burden in these patients.
PROTOCOL 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.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--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:
Surgery: Not specified
Other:
--Patient Characteristics--
Age: Over 18
Performance status: Karnofsky 60-100%
Life expectancy: At least 12 weeks
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
AND/OR
Pulmonary:
OR
Other:
Location Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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