Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00019786
Status:
COMPLETED
Last Update Posted:
2012-03-23
First Post:
2001-07-11
Brief Title:
Isolated Hepatic Perfusion With Melphalan in Treating Patients With Primary Unresectable Liver Cancer or Liver Metastases
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase II Study of Isolated Hepatic Perfusion IHP With Melphalan for Metastatic Unresectable Cancers of the Liver
Status:
COMPLETED
Status Verified Date:
2012-03
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving drugs in different ways may kill more tumor cells
PURPOSE This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases
PURPOSE This phase II trial is studying how well isolated hepatic perfusion with melphalan works in treating patients with primary unresectable liver cancer or liver metastases
Detailed Description:
OBJECTIVES
Determine response rate duration of response and patterns of recurrence in patients with primary or metastatic unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan
Determine the disease-free and overall survival of patients treated with this regimen
OUTLINE Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity Patients with peritoneal seeding unresectable extrahepatic metastases or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment Remaining patients receive isolated hepatic perfusion with melphalan Liver perfusion proceeds for 1 hour
Patients are followed at 6 weeks every 3 months for 2 years and then every 4 months until disease progression
PROJECTED ACCRUAL A maximum of 67 patients will be accrued for this study
Determine response rate duration of response and patterns of recurrence in patients with primary or metastatic unresectable cancers of the liver after treatment with isolated hepatic perfusion with melphalan
Determine the disease-free and overall survival of patients treated with this regimen
OUTLINE Patients who are otherwise eligible undergo an exploratory laparotomy of the peritoneal cavity Patients with peritoneal seeding unresectable extrahepatic metastases or unresectable pathologically-involved lymph nodes outside area of portahepatis do not receive treatment Remaining patients receive isolated hepatic perfusion with melphalan Liver perfusion proceeds for 1 hour
Patients are followed at 6 weeks every 3 months for 2 years and then every 4 months until disease progression
PROJECTED ACCRUAL A maximum of 67 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067220 | None | None | None |
| 99-C-0123 | None | None | None |