Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00324727
Status:
COMPLETED
Last Update Posted:
2021-06-21
First Post:
2006-05-10
Brief Title:
Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma
Sponsor:
Delcath Systems Inc
Organization:
Delcath Systems Inc
Study Overview
Official Title:
A Random-Assignment Study of Hepatic Arterial Infusion of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion PHP Delcath System Versus Best Alternative Care for Ocular and Cutaneous Melanoma Metastatic to the Liver
Status:
COMPLETED
Status Verified Date:
2021-06
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 such as melphalan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving melphalan directly into the arteries around the tumor may kill more tumor cells It is not yet known whether hepatic arterial infusion with melphalan is more effective than standard therapy in treating liver metastases due to melanoma
PURPOSE This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma
PURPOSE This randomized phase III trial is studying hepatic arterial infusion with melphalan to see how well it works compared to standard therapy in treating patients with unresectable liver metastases due to melanoma
Detailed Description:
OBJECTIVES
Primary
Compare the hepatic progression-free survival of patients with unresectable liver metastases secondary to ocular or cutaneous melanoma treated with percutaneous isolated hepatic arterial perfusion PHP with melphalan with subsequent venous hemofiltration vs the best alternative standard treatment
Secondary
Determine the response rate and duration of response in patients treated with melphalan PHP
Determine the patterns of recurrence in patients treated with melphalan PHP
Compare the overall survival of patients treated with these regimens
Compare the safety and tolerability of these regimens in these patients
Determine the pharmacokinetics of melphalan after PHP
OUTLINE This is a multicenter study Patients are stratified according to site of disease ocular vs cutaneous Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1 Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity
Arm II Patients receive the best alternative therapy comprising supportive care systemic or regional chemotherapy hepatic artery chemo-embolization or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician Patients may cross over to arm I if they have evidence of disease progression
Blood samples are collected periodically for pharmacokinetic analysis of melphalan
After completion of study treatment patients are followed periodically for 4 years and then annually for survival
PROJECTED ACCRUAL A total of 92 patients will be accrued for this study
Primary
Compare the hepatic progression-free survival of patients with unresectable liver metastases secondary to ocular or cutaneous melanoma treated with percutaneous isolated hepatic arterial perfusion PHP with melphalan with subsequent venous hemofiltration vs the best alternative standard treatment
Secondary
Determine the response rate and duration of response in patients treated with melphalan PHP
Determine the patterns of recurrence in patients treated with melphalan PHP
Compare the overall survival of patients treated with these regimens
Compare the safety and tolerability of these regimens in these patients
Determine the pharmacokinetics of melphalan after PHP
OUTLINE This is a multicenter study Patients are stratified according to site of disease ocular vs cutaneous Patients are randomized to 1 of 2 treatment arms
Arm I Patients undergo an isolated hepatic arterial infusion of melphalan over 30 minutes on day 1 Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity Patients with complete or partial response undergo 2 additional courses in the absence of ongoing or increasing toxicity
Arm II Patients receive the best alternative therapy comprising supportive care systemic or regional chemotherapy hepatic artery chemo-embolization or any other appropriate therapy at the National Cancer Institute or therapy at the discretion of their physician Patients may cross over to arm I if they have evidence of disease progression
Blood samples are collected periodically for pharmacokinetic analysis of melphalan
After completion of study treatment patients are followed periodically for 4 years and then annually for survival
PROJECTED ACCRUAL A total of 92 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-P6701 | None | None | None |
| NCI-06-C-0088 | None | None | None |