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Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014248 |
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 | Intervention | Phase |
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Cachexia Unspecified Adult Solid Tumor, Protocol Specific |
Drug: adenosine triphosphate Procedure: quality-of-life assessment |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 |
Study ID Numbers: | CDR0000068522, DMS-0005, ATP-DMS-0005, NCI-G01-1923 |
Study First Received: | April 10, 2001 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00014248 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific cachexia |
Body Weight Signs and Symptoms Vasodilator Agents Weight Loss Body Weight Changes Cachexia |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Emaciation Adenosine |
Vasodilator Agents Physiological Effects of Drugs Cachexia Cardiovascular Agents Emaciation Pharmacologic Actions Body Weight Signs and Symptoms Sensory System Agents |
Therapeutic Uses Weight Loss Body Weight Changes Anti-Arrhythmia Agents Analgesics Peripheral Nervous System Agents Adenosine Central Nervous System Agents |