Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096083
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2004-11-09
Brief Title:
Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer
Sponsor:
Delcath Systems Inc
Organization:
Delcath Systems Inc
Study Overview
Official Title:
A Phase II Study Of Hepatic Arterial Infusion Of Melphalan With Venous Filtration Via Peripheral Hepatic Perfusion PHP For Unresectable Primary And Metastatic Cancers Of The Liver
Status:
COMPLETED
Status Verified Date:
2013-10
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 Hepatic arterial infusion uses a catheter to deliver anticancer substances directly into the liver Drugs used in chemotherapy such as melphalan work in 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 giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer
PURPOSE This phase II trial is studying how well giving an hepatic arterial infusion of melphalan together with hepatic perfusion works in treating patients with unresectable liver cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate and duration of response in patients with unresectable primary or metastatic liver cancer treated with intrahepatic arterial infusion of melphalan with venous filtration via peripheral hepatic perfusion
Secondary
Determine the patterns of recurrence in patients treated with this regimen
Determine progression-free and overall survival of patients treated with this regimen
Evaluate the safety and tolerability of this regimen in these patients
Assess the filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors during and after treatment
OUTLINE Patients are stratified according to primary tumor histology neuroendocrine tumor vs primary hepatic malignancy vs adenocarcinoma of gastrointestinal or other origin
Patients undergo peripheral isolated hepatic perfusion in which a catheter is placed via the groin into the hepatic artery and another into the hepatic vein Patients then receive melphalan as an intrahepatic arterial infusion over 15-30 minutes Treatment repeats approximately every 3-8 weeks for up to 6 total infusions in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 4 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 105 patients will be accrued for this study within 4-5 years
Primary
Determine the response rate and duration of response in patients with unresectable primary or metastatic liver cancer treated with intrahepatic arterial infusion of melphalan with venous filtration via peripheral hepatic perfusion
Secondary
Determine the patterns of recurrence in patients treated with this regimen
Determine progression-free and overall survival of patients treated with this regimen
Evaluate the safety and tolerability of this regimen in these patients
Assess the filter characteristics including melphalan pharmacokinetics and filtration of cytokines and clotting factors during and after treatment
OUTLINE Patients are stratified according to primary tumor histology neuroendocrine tumor vs primary hepatic malignancy vs adenocarcinoma of gastrointestinal or other origin
Patients undergo peripheral isolated hepatic perfusion in which a catheter is placed via the groin into the hepatic artery and another into the hepatic vein Patients then receive melphalan as an intrahepatic arterial infusion over 15-30 minutes Treatment repeats approximately every 3-8 weeks for up to 6 total infusions in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 4 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 105 patients will be accrued for this study within 4-5 years
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 |
|---|---|---|---|
| DELCATH-G990039 | None | None | None |
| NCI-04-C-0273 | None | None | None |
| NCI-6332 | None | None | None |