Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093444
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2004-10-06
Brief Title:
Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as liposomal doxorubicin work in different ways to stop tumor cells from dividing so they stop growing or die Radiofrequency ablation uses high-frequency electric current to kill tumor cells Combining radiofrequency ablation with liposomal doxorubicin may increase the effectiveness of the drug and kill more tumor cells
PURPOSE This phase I trial is studying the best dose of liposomal doxorubicin when given with radiofrequency ablation in treating patients with primary or metastatic liver tumors
PURPOSE This phase I trial is studying the best dose of liposomal doxorubicin when given with radiofrequency ablation in treating patients with primary or metastatic liver tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when combined with radiofrequency ablation in patients with primary or metastatic tumors of the liver
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
OUTLINE This is a dose-escalation study of heat activated doxorubicin HCl liposome
Patients receive doxorubicin HCl liposome IV over 30 minutes Approximately 15 minutes after the beginning of the doxorubicin HCl liposome infusion patients undergo radiofrequency ablation with needles inserted into the tumors and heated to the target temperature for approximately 12-60 minutes
Cohorts of 3-6 patients receive escalating doses of heat activated doxorubicin HCl liposome 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 At least 6 patients are treated at the MTD
Patients are followed at 28 days every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 2 years
Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when combined with radiofrequency ablation in patients with primary or metastatic tumors of the liver
Determine the pharmacokinetics and pharmacodynamics of this drug in these patients
OUTLINE This is a dose-escalation study of heat activated doxorubicin HCl liposome
Patients receive doxorubicin HCl liposome IV over 30 minutes Approximately 15 minutes after the beginning of the doxorubicin HCl liposome infusion patients undergo radiofrequency ablation with needles inserted into the tumors and heated to the target temperature for approximately 12-60 minutes
Cohorts of 3-6 patients receive escalating doses of heat activated doxorubicin HCl liposome 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 At least 6 patients are treated at the MTD
Patients are followed at 28 days every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL Approximately 30 patients will be accrued for this study within 2 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 |
|---|---|---|---|
| CDR0000387979 | None | None | None |
| 04-C-0263 | None | None | None |
| CELSION-10403101 | None | None | None |