Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT00014248
• Recruitment Status: Completed
• First Posted: July 30, 2003
• Last Update Posted: March 18, 2013
• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Dartmouth-Hitchcock Medical Center

Tracking Information

• First Submitted Date: April 10, 2001
• First Posted Date: July 30, 2003
• Last Update Posted Date: March 18, 2013
• Study Start Date: October 2000
• Actual Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00014248 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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)

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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Primary Purpose: Supportive Care

Condition

• Cachexia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

• Drug: adenosine triphosphate
• Procedure: quality-of-life assessment

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Study Completion Date: Not Provided
• Actual Primary Completion Date: November 2002 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00014248
• Other Study ID Numbers: CDR0000068522; DMS-0005; ATP-DMS-0005; NCI-G01-1923
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dartmouth-Hitchcock Medical Center
• Study Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: National Cancer Institute (NCI)

Investigators

• Study Chair: Lionel D. Lewis, MD; Norris Cotton Cancer Center

• PRS Account: Dartmouth-Hitchcock Medical Center
• Verification Date: March 2013