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Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center Identifier:
First received: April 10, 2001
Last updated: March 15, 2013
Last verified: March 2013

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

Study Type: Interventional
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)

Resource links provided by NLM:

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Study Start Date: October 2000
Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00014248

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)
Study Chair: Lionel D. Lewis, MD Norris Cotton Cancer Center
  More Information

Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT00014248     History of Changes
Other Study ID Numbers: CDR0000068522
Study First Received: April 10, 2001
Last Updated: March 15, 2013

Keywords provided by Dartmouth-Hitchcock Medical Center:
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Wasting Syndrome
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
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 processed this record on September 21, 2017