NCT00093444

Heat Activated Liposomal Doxorubicin and Radiofrequency Ablation in Treating Patients With Primary or Metastatic Liver Tumors

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 tumor(s) 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.

Conditions

• Liver Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	lyso-thermosensitive liposomal doxorubicin
PROCEDURE	radiofrequency ablation

Timeline

• Start date: 2004-09-01
• Completion: 2010-01-01
• First posted: 2004-10-08
• Last updated: 2012-03-15

Locations

2 sites across 2 countries: United States, China