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Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

Primary Purpose

Cachexia, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
adenosine triphosphate
quality-of-life assessment
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cachexia focused on measuring unspecified adult solid tumor, protocol specific, cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Norris Cotton Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 10, 2001
Last Updated
March 15, 2013
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00014248
Brief Title
Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
November 2002 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cachexia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, cachexia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
adenosine triphosphate
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lionel D. Lewis, MD
Organizational Affiliation
Norris Cotton Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Norris Cotton Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States

12. IPD Sharing Statement

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Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

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