Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030082
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2002-01-30
Brief Title:
Hepatic Arterial Infusion With Melphalan in Treating Patients With Unresectable Liver Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Hepatic Arterial Infusion of Escalating Dose Melphalan With Venous Filtration for Metastatic Unresectable Cancers of the Liver
Status:
COMPLETED
Status Verified Date:
2004-07
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 Heating melphalan to several degrees above body temperature and infusing it to the affected area directly around the tumor may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer
PURPOSE Phase I trial to study the effectiveness of hepatic arterial infusion with melphalan in treating patients who have unresectable liver cancer
Detailed Description:
OBJECTIVES
Determine the dose-limiting toxicity and maximum tolerated dose of hepatic arterial infusion with melphalan in patients with unresectable liver cancer
Determine the regional and systemic toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients undergo percutaneous hepatic arterial infusion using a double balloon catheter in the inferior vena cava to isolate circulation to the liver with melphalan over 30 minutes on day 1 Treatment may be repeated when all toxic effects are grade 2 or less Patients undergo staging at 4 weeks after completion of the second treatment Patients may receive 2 additional treatments
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 12 additional patients are treated with melphalan at the recommended dose
Patients are followed every 3 months for 2 years and then every 4 months for 1 year
PROJECTED ACCRUAL A total of 44 patients will be accrued for this study
Determine the dose-limiting toxicity and maximum tolerated dose of hepatic arterial infusion with melphalan in patients with unresectable liver cancer
Determine the regional and systemic toxic effects of this drug in these patients
Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation study
Patients undergo percutaneous hepatic arterial infusion using a double balloon catheter in the inferior vena cava to isolate circulation to the liver with melphalan over 30 minutes on day 1 Treatment may be repeated when all toxic effects are grade 2 or less Patients undergo staging at 4 weeks after completion of the second treatment Patients may receive 2 additional treatments
Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 12 additional patients are treated with melphalan at the recommended dose
Patients are followed every 3 months for 2 years and then every 4 months for 1 year
PROJECTED ACCRUAL A total of 44 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 |
|---|---|---|---|
| NCI-01-C-0215 | None | None | None |