Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014248
Status:
COMPLETED
Last Update Posted:
2013-03-18
First Post:
2001-04-10
Brief Title:
Adenosine Triphosphate in Treating Patients With Advanced Solid Tumors
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G01-1923 | None | None | None |
| DMS-0005 | None | None | None |
| ATP-DMS-0005 | None | None | None |