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Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014248
Recruitment Status : Completed
First Posted : July 30, 2003
Last Update Posted : March 18, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Cachexia Unspecified Adult Solid Tumor, Protocol Specific Drug: adenosine triphosphate Procedure: quality-of-life assessment Phase 1

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
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
Actual Primary Completion Date : November 2002

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed advanced solid tumor that is not curable by conventional therapy
  • Brain metastases allowed if adequately controlled with radiotherapy



  • Over 18

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks


  • 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


  • 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


Biologic therapy:

  • Not specified


  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

Endocrine therapy:

  • Not specified


  • 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
  • No concurrent maintenance anti-anginal drug therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014248

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United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
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Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00014248    
Other Study ID Numbers: CDR0000068522
First Posted: July 30, 2003    Key Record Dates
Last Update Posted: March 18, 2013
Last Verified: March 2013
Keywords provided by Dartmouth-Hitchcock Medical Center:
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action