Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109941
Status:
COMPLETED
Last Update Posted:
2018-09-06
First Post:
2005-05-03
Brief Title:
Opioid Growth Factor in Treating Patients With Advanced Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Treatment of Advanced Pancreatic Cancer With Opioid Growth Factor OGF Phase II
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:
OGF
Brief Summary:
RATIONALE Opioid growth factor may stop the growth of pancreatic cancer by blocking blood flow to the tumor
PURPOSE This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well opioid growth factor works in treating patients with advanced pancreatic cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the growth inhibitory effects of opioid growth factor Met5-enkephalin in patients with advanced unresectable pancreatic cancer
Secondary
Determine the pharmacokinetics of this drug in these patients
Determine the quality of life of patients treated with this drug
Determine the pain control depression and nutritional status of patients treated with this drug
OUTLINE This is an open-label study
Patients receive opioid growth factor Met5-enkephalin IV over 45 minutes once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 4 weeks during study treatment and at the completion of study treatment
Patients are followed weekly for survival
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the growth inhibitory effects of opioid growth factor Met5-enkephalin in patients with advanced unresectable pancreatic cancer
Secondary
Determine the pharmacokinetics of this drug in these patients
Determine the quality of life of patients treated with this drug
Determine the pain control depression and nutritional status of patients treated with this drug
OUTLINE This is an open-label study
Patients receive opioid growth factor Met5-enkephalin IV over 45 minutes once weekly Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline every 4 weeks during study treatment and at the completion of study treatment
Patients are followed weekly for survival
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| FD-R-0002391 | OTHER_GRANT | None | None |
| M01RR010732 | NIH | FDA OOPD Grant FD-R-0002391 | httpsreporternihgovquickSearchM01RR010732 |