A Phase I Dose Escalation Study Of Heat Activated Liposome Delivery Of Doxorubicin And Radiofrequency Ablation Of Primary And Metastatic Tumors Of The Liver
- Determine the maximum tolerated dose of heat activated doxorubicin HCl liposome when
combined with radiofrequency ablation in patients with primary or metastatic tumors of
- 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
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Maximum tolerated dose of heat-activated doxorubicin HCL liposome
Bradford Wood, MD
National Cancer Institute (NCI)
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|