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CompletedNCT00014248Updated Mar 18, 2013

Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

A Phase 1 interventional study of adenosine triphosphate and quality-of-life assessment in Cachexia and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-03-18.

Sponsored by Dartmouth-Hitchcock Medical Center · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

  • 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.

02

Conditions studied

  • Cachexia
  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • unspecified adult solid tumor, protocol specific
  • cachexia
03

In context

Wasting Syndrome

196 studies on the registry are indexed under Wasting Syndrome; 22 are open to participants now.

Browse Wasting Syndrome studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • WBC at least 3,500/mm\^3
  • Absolute neutrophil count at least 2,000/mm\^3
  • Platelet count at least 100,000/mm\^3

Hepatic:

  • SGOT and SGPT no greater than 3 times normal
  • Bilirubin no greater than 2.0 mg/dL

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance greater than 60 mL/min
  • BUN no greater than 25 mg/dL

Cardiovascular:

  • 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)

Pulmonary:

  • 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

Other:

  • 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

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:

  • See Disease Characteristics
  • At least 3 weeks since prior radiotherapy and recovered

Surgery:

  • Not specified

Other:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Supportive care

Interventions

  • Drugadenosine triphosphate
  • Procedurequality-of-life assessment
06

Study locations

1 site
  • Norris Cotton Cancer Center
    Lebanon, New Hampshire 03756-0002, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00014248
Lead sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jul 30, 2003
Start date
Oct 2000
Primary completion
Nov 2002
Last update
Mar 18, 2013

Study contacts

Lionel D. Lewis, MD
study chair · Norris Cotton Cancer Center
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2013. You cannot join it, but the record below documents what was studied.

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