A Study of ThermoDox™ in Combination With Radiofrequency Ablation (RFA) in Primary and Metastatic Tumors of the Liver
NCT00441376 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2019-02-07
Summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of ThermoDox when used in combination with radiofrequency ablation (RFA) in the treatment of primary and metastatic tumors of the liver.
Conditions
- Hepatocellular Carcinoma
- Liver Neoplasms
Interventions
- DRUG
-
ThermoDox
15 ml vial containing 2mg/ml Doxorubicin HCl, DPPC, MSPC, DSPE-MPEG 2000. Administered as single dose intravenously over 30 minutes. Dose is determined by dose cohort patient enters study.
Sponsors & Collaborators
-
Imunon
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-02-28
- Primary Completion
- 2008-10-31
- Completion
- 2009-12-31
Countries
- United States
Study Locations
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